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Sample records for hysteroscopy randomized study

  1. Hysteroscopy

    Science.gov (United States)

    ... for hysteroscopy is to find the cause of abnormal uterine bleeding. Abnormal bleeding can mean that a woman’s menstrual ... menstrual periods also is abnormal (see the FAQ Abnormal Uterine Bleeding) . Hysteroscopy also is used in the following situations: • ...

  2. [Efficacy of intravenous dexketoprofen trometamol compared to intravenous paracetamol for postoperative pain management after day-case operative hysteroscopy: randomized, double-blind, placebo-controlled study].

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    Koçum, Aysu; Sener, Mesut; Izmirli, Hatice; Haydardedeoğlu, Bülent; Arıboğan, Anış

    2014-01-01

    Adequate pain management following day-case surgery allows early ambulation of patients. In this study, we aimed to compare postoperative analgesic efficacy of intravenous (iv) dexketoprofen vs. iv paracetamol following day-case operative hysteroscopy. One hundred and fourteen American Society of Anesthesiologists (ASA) I-II patients scheduled for day-case operative hysteroscopy were recruited and randomized to three groups in the study. Group D received 50 mg iv dexketoprofen trometamol, Group P 1000 mg iv paracetamol and Group C normal saline solution. Visual Analogue Scale (VAS) pain intensity, pain relief, sedation, nausea-vomiting, other side effects, and additional opioid analgesic requirement were noted at postoperative 15 minutes (min), 30 min, 1 hour (h), 2 h, and 3 h. Patients with VAS>=40 mm received meperidine 0.25 mg/kg as rescue analgesic medication. VAS scores at 15 min, 30 min, 1 h, and 2 h were significantly lower in Group D compared to Group C. VAS scores at 15 min and 30 min were significantly lower in Group D compared to Group P. The percentages of patients who required opioid treatment were 34%, 60%, and 63% in Groups D, P and C, respectively (pdexketoprofen has superior efficacy for postoperative pain management following day-case operative hysteroscopy when compared with paracetamol and placebo.

  3. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial.

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    Mazzon, Ivan; Favilli, Alessandro; Grasso, Mario; Horvath, Stefano; Bini, Vittorio; Di Renzo, Gian Carlo; Gerli, Sandro

    2014-11-01

    To study which variables are able to influence women's experience of pain during diagnostic hysteroscopy. Multivariate analysis (phase II) after a randomized, controlled trial (phase I). Endoscopic gynecologic center. In phase I, 392 patients were analyzed. Group A: 197 women with carbon dioxide (CO2); group B: 195 women with normal saline. In phase II, 392 patients were assigned to two different groups according to their pain experience as measured by a visual analogue scale (VAS): group VAS>3 (170 patients); group VAS≤3 (222 patients). Free-anesthesia diagnostic hysteroscopy performed using CO2 or normal saline as distension media. Procedure time, VAS score, image quality, and side effects during and after diagnostic hysteroscopy. In phase I the median pain score in group A was 2, whereas in group B it was 3. In phase II the duration of the procedure, nulliparity, and the use of normal saline were significantly correlated with VAS>3. A higher presence of cervical synechiae was observed in the group VAS>3. The multivariate analysis revealed an inverse correlation between parity and a VAS>3, whereas the use of normal saline, the presence of synechiae in the cervical canal, and the duration of the hysteroscopy were all directly correlated to a VAS score>3. Pain in hysteroscopy is significantly related to the presence of cervical synechiae, to the duration of the procedure, and to the use of normal saline; conversely, parity seems to have a protective role. NCT01873391. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  4. Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial.

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    El-Khayat, Waleed; Elsadek, Mostafa; Saber, Waleed

    2015-11-01

    To evaluate the role of endometrial injury in the cycle preceding ovarian stimulation for intrauterine insemination (IUI) cycle on the clinical pregnancy rate. This was a prospective randomized controlled trial which included three hundred and thirty two infertile women with an indication for IUI. The subjects were randomly divided into two groups. The intervention group (group A) (n=166) subjects underwent office hysteroscopy with endometrial injury using grasping forceps with teeth, while the control group (group B) (n=166) subjects underwent office hysteroscopy alone without endometrial injury. Primary outcome was clinical pregnancy rate. There were no significant differences in baseline or clinical characteristics between the groups. There were no significant differences in clinical pregnancy rate [13.8% (23/166) versus 12% (20/166); RR 1.15 (95% CI 0.66-2.01), p=0.62]. The abortion rate [4.3% (1/23) versus 15% (3/20); RR 0.29 (95% CI 0.03-2.57), p=0.27], the multiple pregnancy rate [13% (3/23) versus 15% (3/20); RR 0.87 (95% CI 0.20-3.83), p=0.85] and the live birth rate [13.6% (22/166) versus 10.4% (17/166); RR 1.28 (95% CI 0.71-2.32), p=0.42]. There is no evidence of significant difference on the clinical pregnancy rate when endometrial scratching during hysteroscopy is compared to only hysteroscopy in women undergoing IUI. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. 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.

  6. Cost-effectiveness of hysteroscopy screening for infertile women.

    Science.gov (United States)

    Kasius, Jenneke C; Eijkemans, René J C; Mol, Ben W J; Fauser, Bart C J M; Fatemi, Human M; Broekmans, Frank J M

    2013-06-01

    This study assessed the cost-effectiveness of office hysteroscopy screening prior to IVF. Therefore, the cost-effectiveness of two distinct strategies - hysteroscopy after two failed IVF cycles (Failedhyst) and routine hysteroscopy prior to IVF (Routinehyst) - was compared with the reference strategy of no hysteroscopy (Nohyst). When present, intrauterine pathology was treated during hysteroscopy. Two models were constructed and evaluated in a decision analysis. In model I, all patients had an increase in pregnancy rate after screening hysteroscopy prior to IVF; in model II, only patients with intrauterine pathology would benefit. For each strategy, the total costs and live birth rates after a total of three IVF cycles were assessed. For model I (all patients benefit from hysteroscopy), Routinehyst was always cost-effective compared with Nohyst or Failedhyst. For the Routinehyst strategy, a monetary profit would be obtained in the case where hysteroscopy would increase the live birth rate after IVF by ≥ 2.8%. In model II (only patients with pathology benefit from hysteroscopy), Routinehyst also dominated Failedhyst. However, hysteroscopy performance resulted in considerable costs. In conclusion, the application of a routine hysteroscopy prior to IVF could be cost-effective. However, randomized trials confirming the effectiveness of hysteroscopy are needed. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  7. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial.

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    Hassan, A; Wahba, A; Haggag, H

    2016-01-01

    Which is better, Tramadol or Celecoxib, in reducing pain associated with outpatient hysteroscopy? Both Tramadol and Celecoxib are effective in reducing pain associated with outpatient hysteroscopy but Celecoxib may be better tolerated. Pain is the most common cause of failure of outpatient hysteroscopy. A systematic review and meta-analysis showed that local anaesthetics were effective in reducing pain associated with hysteroscopy but there was insufficient evidence to support the use of oral analgesics, opioids and non-steroidal anti-inflammatory drugs, to reduce hysteroscopy-associated pain and further studies were recommended. This was a randomized double-blind placebo-controlled trial with balanced randomization (allocation ratio 1:1:1) conducted in a university hospital from May 2014 to November 2014. Two hundred and ten women who had diagnostic outpatient hysteroscopy were randomly divided into three equal groups: Group 1 received oral Tramadol 100 mg, group 2 received Celecoxib 200 mg and group 3 received an oral placebo. All the drugs were given 1 h before the procedure. A patient's perception of pain was assessed during the procedure, immediately afterwards and 30 min after the procedure with the use of a visual analogue scale (VAS). There was a significant difference in the pain scores among the groups during the procedure, immediately afterwards and 30 min after the procedure (Ppain scores when compared with the placebo during the procedure (mean difference = 1.54, 95% confidence interval (CI) (0.86, 2.22), P pain scores than the placebo during the procedure (mean difference = 1.28, 95% CI (0.62, 1.94), P pain scores between Tramadol and Celecoxib at any time. Time until no pain differed significantly among the groups (P = 0.01); it was shorter with both Tramadol and Celecoxib groups when compared with placebo (P = 0.002 and 0.046, respectively). The procedure failed to be completed in one patient in the placebo group but no failure to complete the

  8. Hysterography and hysteroscopy. A comparative study with 50 patients

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    De Vivo, D; Valentini, A L; La Vecchia, G; Ceccarelli, D; Vincenzoni, M; Palla, G

    1986-01-01

    Hysterography and hysteroscpy have been compared in the diagnosis of endouterine benign pathology, in a group of 50 patients, complaining memo-metrorrhagia, sterility, infertility or amenorrhea. Hysterography resulted more sensible (95.3%), but less specific (86.3%) than hysteroscopy (88.8% and 95.6%). 18 refs.

  9. Pain during diagnostic hysteroscopy: what is the role of the cervical canal? A pilot study.

    Science.gov (United States)

    Mazzon, Ivan; Favilli, Alessandro; Horvath, Stefano; Grasso, Mario; Di Renzo, Gian Carlo; Laurenti, Elena; Bini, Vittorio; Gerli, Sandro

    2014-12-01

    To evaluate whether a correlation exists between the pain perceived during diagnostic anesthesia-free hysteroscopy and the characteristics of the cervical canal. Prospective observational pilot study of 255 women undergoing diagnostic hysteroscopy. Data analysis included characteristics of the patient and the cervical canal, and the pain experience during the procedure, assessed by visual analog score (VAS). A multiple logistic regression was then carried out in order to exclude confounding factors. The degree of pain during hysteroscopy was equal to a median VAS score of 2 (range 0-10). Bivariate analysis between patients with VAS>3 and patients with VAS≤3 demonstrated a significant correlation between pain and the presence of synechiae in the cervical canal (P=0.022), the patient's age (P=0.003) and parity (P=0.001). Multivariate analysis revealed that the presence of cervical synechiae (P=0.0001) [OR=4.99 (95% CI 2.13-11.70)] and parity (P=0.014) [OR=0.42 (95% CI 0.21-0.83)] were significantly correlated with pain. There was no significant correlation with the different angles of the cervical canal. Cervical synechiae appear as a major factor influencing pain during hysteroscopy. While parity acts as a protective factor, the angle of the cervical canal does not seem to play an important role for pain during diagnostic hysteroscopy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. Optimal Order of Successive Office Hysteroscopy and Endometrial Biopsy for the Evaluation of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

    Science.gov (United States)

    Sarkar, Papri; Mikhail, Emad; Schickler, Robyn; Plosker, Shayne; Imudia, Anthony N

    2017-09-01

    To estimate the optimal order of office hysteroscopy and endometrial biopsy when performed successively for evaluation of abnormal uterine bleeding. Patients undergoing successive office hysteroscopy and endometrial biopsy were included in a single-blind, prospective, randomized trial. The primary outcome was to evaluate the effect of order of procedures on patients' pain score. Prespecified secondary outcomes include procedure duration, hysteroscopic visualization of the uterine cavity, endometrial sample adequacy, and number of attempts at biopsy. Pain scores were assessed using a visual analog scale from 0 to 10 and endometrial sample adequacy was determined from the histopathology report. Hysteroscopy images were recorded. Sample size of 34 per group (n=68) was determined to be adequate to detect a difference of 20% in visual analog scale score between hysteroscopy first (group A) and biopsy first (group B) at α of 0.05 and 80% power. Between October 2015 and January 2017, 78 women were randomized to group A (n=40) and group B (n=38). There was no difference in global pain perception [7 (0-10) vs 7 (0-10); P=.57, 95% CI 5.8-7.1]. Procedure duration [3 (1-9) vs 3 (2-10), P=.32, 95% CI 3.3-4.1] and endometrial sample adequacy (78.9% vs 75.7%, P=.74) were similar in both groups. Group A patients had better endometrial visualization (Pabnormal uterine bleeding, the global pain perception, and time required are independent of the order in which procedures are performed. Performing hysteroscopy first ensures better image, whereas biopsy first yields adequate tissue sample with fewer attempts. ClinicalTrials.gov, NCT02472184.

  11. Office Hysteroscopy

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    Hikmet Hassa; Basar Tekin; H. Mete Tanir; Bulent Cakmak

    2007-01-01

    Although hysteroscopy has evolved in recent years, its use in the office setting was not made practical until early 1980s with the introduction of small caliber hysteroscopes of less than 5- mm outer diameter.This innovation simplifies ambulatory uterine exploration and the office evaluation of patients with abnormal uterine bleeding. This article reviews current trends in office hysteroscopy and its areas of application in different forms of gynecological problems.

  12. Office Hysteroscopy

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    Hikmet Hassa

    2007-06-01

    Full Text Available Although hysteroscopy has evolved in recent years, its use in the office setting was not made practical until early 1980s with the introduction of small caliber hysteroscopes of less than 5- mm outer diameter.This innovation simplifies ambulatory uterine exploration and the office evaluation of patients with abnormal uterine bleeding. This article reviews current trends in office hysteroscopy and its areas of application in different forms of gynecological problems.

  13. Hysteroscopy in bitches.

    Science.gov (United States)

    Gerber, D; Nöthling, J O

    2001-01-01

    The aim of this study was to determine whether the canine endometrium could be examined by hysteroscopy. Eight German shepherd bitches were used. Two bitches were in dioestrus, five were in anoestrus and one was about 8 weeks post partum. The uterus was exposed through a ventral celiotomy. A 3 mm straight laparoscope or a 4 mm laparoscope with a 30 degrees angle, and a catheter for inflation of the uterus were used. After hysteroscopy the bitches were spayed and the uterus of each bitch was examined macroscopically and histologically. Endometrium and uterotubal junctions were visible in all bitches. The cervix and caudal uterine body could not be visualized in three bitches as two bitches had uterine discharge and air escaped through the cervix in the other bitch. In the post-partum bitch, dark-brown sites of implantation were observed. Four bitches (aged 9, 22, 25 and 31 months) had endometrial cysts (0.5-2.0 mm in diameter). Hysteroscopy caused petechiae and ecchymosis in the endometrium of four bitches. Traumatization of the endometrium affected only the epithelium and the most superficial part of the lamina propria. In conclusion, hysteroscopy appears to be a very sensitive tool for evaluation of the canine endometrium. Further research is necessary to determine the effects of hysteroscopy on subsequent fertility.

  14. 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.

  15. Tolerability of hysteroscopy under local anaesthesia

    International Nuclear Information System (INIS)

    Nasrullah, F.D.; Khan, A.

    2007-01-01

    To assess the tolerability of hysteroscopy amongst patients, when performed under local anesthesia. Patients attending the Outpatient Clinics with bleeding per vagina were randomly selected. After the clinical work-up and taking consent, all patients were given injection diclofenac sodium half an hour prior to the procedure. After preparing and positioning the patient,10cc of injection Bupivacaine was given for para cervical block at 3 and 9 o'clock positions. The uterine cavity was distended with normal saline. Hysteroscopy was performed and the findings noted. Pain scoring was done by visual analogue scale. The condition of the patient was monitored during and after the procedure; they were kept under observation for four hours. Tolerability of the procedure was assessed by pain scoring and the presence of complications, and the results analyzed. During the study period 113 patients underwent hysteroscopy for abnormal uterine bleeding. The procedure was performed successfully in 98.2% patients without any complications, while 1.8% patients experienced transient vasovagal attack. The procedure was painless in 52.2% patients; 40.7% patients had mild pain (score <3) and were reassured, whereas 7.1% patients had moderate pain (score 3-5). Only 3.5% cases required analgesia for pain control. All patients remained haemodynamically stable during and after the procedure. Hysteroscopy is very well tolerated under local anaesthesia by our local population. (author)

  16. Objective Structured Assessment of Technical Skills (OSATS) evaluation of hysteroscopy training: a prospective study.

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    Alici, Ferizan; Buerkle, Bernd; Tempfer, Clemens B

    2014-07-01

    To describe the performance curve of hysteroscopy-naïve probands repeatedly working through a surgery algorithm on a hysteroscopy trainer. We prospectively recruited medical students to a 30min demonstration session teaching a standardized surgery algorithm. Subjects subsequently performed three training courses immediately after training (T1) and after 24h (T2) and 48h (T3). Skills were recorded with a 20-item Objective Structured Assessment of Technical Skills (OSATS) at T1, T2, and T3. The presence of a sustained OSATS score improvement from T1 to T3 was the primary outcome. Performance time (PT) and self assessment (SA) were secondary outcomes. Statistics were performed using paired T-test and multiple linear regression analysis. 92 subjects were included. OSATS scores significantly improved over time from T1 to T2 (15.21±1.95 vs. 16.02±2.06, respectively; ptraining courses on a hysteroscopy trainer. Serial hysteroscopy trainings may be helpful for teaching hysteroscopy skills. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Office hysteroscopy: A report of 2402 cases.

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    Capmas, P; Pourcelot, A-G; Giral, E; Fedida, D; Fernandez, H

    2016-05-01

    Hysteroscopy is the gold standard for evaluation of uterine cavity. It can be performed either as office setting or as day care procedure under general anaesthesia. Objective of this study is to assess feasibility and acceptability of office hysteroscopy without anaesthesia. This retrospective observational study took place in the gynaecologic unit of a teaching hospital. Women who had had an office hysteroscopy from 2010 to 2013 were included. Two thousand four hundred and two office hysteroscopies were carried out. Indications were menorrhagia (32.2%), postoperative evaluation (20.8%), infertility (15.8%), postmenopausal bleeding (10.9%) and other indications (20.3%). Women's mean age was 39.4 [39.0-39.9] and significantly higher among women with a failure of the office hysteroscopy (47.3 vs. 38.6, Poffice hysteroscopy was 0.05%. Mean pain score during the examination was 3.57 out of 10 [3.48-3.66] and 0.89 [0.83-0.95] five minutes later. Office hysteroscopy is safe and feasible with little pain. A failure rate of 9.5% is reported, mainly for older women with postmenopausal bleeding. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  18. 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

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

    Science.gov (United States)

    Smit, Janine G; Kasius, Jenneke C; Eijkemans, Marinus J C; Koks, Carolien A M; Van Golde, Ron; Oosterhuis, Jurjen G E; Nap, Annemiek W; Scheffer, Gabrielle J; Manger, Petra A P; Hoek, Annemiek; Kaplan, Mesrure; Schoot, Dick B C; van Heusden, Arne M; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M; Sluijmer, Alexander; Friederich, Jaap; Laven, Joop S E; van Hooff, Marcel; Louwe, Leonie A; Kwee, Janet; Boomgaard, Jantien J; de Koning, Corry H; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Torrance, Helen L; Broekmans, Frank J M

    2012-08-08

    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. 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, using univariate and multivariate logistic regression and

  20. Hysterography and hysteroscopy

    International Nuclear Information System (INIS)

    De Vivo, D.; Valentini, A.L.; La Vecchia, G.; Ceccarelli, D.; Vincenzoni, M.; Palla, G.

    1986-01-01

    Hysterography and hysteroscpy have been compared in the diagnosis of endouterine benign pathology, in a group of 50 patients, complaining memo-metrorrhagia, sterility, infertility or amenorrhea. Hysterography resulted more sensible (95.3%), but less specific (86.3%) than hysteroscopy (88.8% and 95.6%)

  1. Hysteroscopy in daily practice

    NARCIS (Netherlands)

    Dongen, Heleen van

    2009-01-01

    In the recent past, the established method for investigating women with abnormal uterine bleeding was dilatation and curettage. When hysteroscopic examination of the uterus proved to be more accurate, diagnostic hysteroscopy with or without endometrial sampling was suggested as the method of choice.

  2. Office hysteroscopy and adenomyosis.

    Science.gov (United States)

    Molinas, Carlos Roger; Campo, Rudi

    2006-08-01

    Adenomyosis, the heterotopic presence of endometrial glands and stroma within the myometrium, has traditionally been diagnosed by the pathologist in hysterectomy specimens. However, the recent development of high-quality non-invasive techniques such as transvaginal sonography (TVS), magnetic resonance imaging (MRI) and hysteroscopy has renewed interest in diagnosing adenomyosis in the office prior to any treatment. Hysteroscopy offers the advantage of direct visualization of the uterine cavity, and since nowadays it is performed in the office, it can be offered as a first-line diagnostic tool for evaluation of uterine abnormalities in patients with abnormal uterine bleeding and/or infertility. The available data clearly indicate that high-quality mini-hysteroscopes, saline as a distension medium, and atraumatic insertion technique are essential for the success of office hysteroscopy. The procedure is indicated in any situation in which an intrauterine anomaly is suspected; it is immediately preceded by a physical exam and a TVS to evaluate uterine characteristics, and it is followed by a second TVS to take advantage of the intracavitary fluid for a contrast image of the uterus. Although diagnostic hysteroscopy does not provide pathognomonic signs for adenomyosis, some evidence suggests that irregular endometrium with endometrial defects, altered vascularization, and cystic haemorrhagic lesion are possibly associated with the entity. In addition to the direct visualization of the uterine cavity, the hysteroscopic approach offers the possibility of obtaining endometrial/myometrial biopsies under visual control. Since they can be performed in the office, the combination of TVS, fluid hysteroscopy and contrast sonography is therefore a powerful screening tool for detecting endometrial and myometrial abnormalities in association with adenomyosis.

  3. 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.

  4. Endometrial hyperplasia in hysteroscopy, Report of 363 cases of hysteroscopy

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    Aghahosseyni M

    1998-05-01

    Full Text Available Hysteroscopy is a new and precise method for evaluating of uterus, so it is valuable in evaluating infertile women. In 18 months, 363 hysteroscopies were done on patients who were visited in IVF center of Shariati Hospital for treatment of infertility. Incidence of abnormal hysteroscopy was 18%. 32% of these abnormal hysteroscopies was endometrial hyperplasia. In evaluating of laparoscopy and other factors of these patients there was a statistically significant relation between diagnosis of PCOD (polycystic ovary disease and endometrial hyperplasia (P<0.008, but there is no significant relation between other diagnoses like endometriosis and endometrial hyperplasia (P<0.4.

  5. [Use of hysteroscopy at the office in gynaecological practice].

    Science.gov (United States)

    Török, Péter

    2014-10-05

    Nowadays minimally invasive techniques are a leading factors in medicine. According to this trend, hysteroscopy has been used in gynecology more and more frequently. Office hysteroscopy gives opportunity for a faster examination with less costs and strain for the patient. The aim of this work was to get familiar with the novel method. The author examined the level of pain during hysteroscopy performed for different indications with different types of instruments. In addition, the novel method invented for evaluating tubal patency was compared to the gold standard laparoscopy in 70 tubes. Office hysteroscopy was performed in 400 cases for indications according to the traditional method. All examinations were performed in University of Debrecen, Department of Obstetrics and Gynecology in an outpatient setting. A 2.7 mm diameter optic with diagnostic or operative sheet was used. Hysteroscopies were scheduled between the 4th and 11th cycle day. For recording pain level VAS was used in 70 cases. Comparison of hysteroscopic evaluation of tubal patency to the laparoscopic method was studies in 70 cases. It was found that office hysteroscopy can be performed in an outpatient setting, without anesthesia. Pain level showed no difference among subgroups (nulliparous, non-nulliparous, postmenopausal, diagnostic, operative) (mean±SD, 3.5±1.01; p=0.34). For the evaluation of tubal patency, office hysteroscopy showed 92.06% accuracy when compared to laparoscopy. Office hysteroscopy has several advantages over traditional method. This procedure is fast, it has less strain for the patient. The novel method, rather than traditional hysteroscopy, should be used in the work-up of infertility as well.

  6. Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy.

    Science.gov (United States)

    Marsh, Fiona; Kremer, Christian; Duffy, Sean

    2004-03-01

    To examine the cost implications of outpatient versus daycase hysteroscopy to the National Health Service, the patient and their employer. Randomised controlled trial. The gynaecology clinic of a large teaching hospital. Ninety-seven women with abnormal uterine bleeding requiring investigation. Women were randomly allocated to either outpatient or daycase hysteroscopy. They were asked to complete diaries recording expenses and time off work. The National Health Service costs were calculated for a standard outpatient and daycase hysteroscopy. Costs to the National Health Service, costs to the employer, loss of income, childcare costs and travel expenses. The outpatient group required significantly less time off work compared with the daycase group (0.8 days vs 3.3 days), P Service approximately pound 53.88 more per patient, than performing an outpatient hysteroscopy. Purchasing the hysteroscopes necessary to perform an outpatient hysteroscopy is a more expensive outlay than those required for daycase hysteroscopy. However, there are so many other savings that only 38 patients need to undergo outpatient hysteroscopy (even with a 4% failure rate) rather than daycase hysteroscopy in order to recoup the extra money required to set up an outpatient hysteroscopy service. Outpatient hysteroscopy offers many benefits over its traditional counterpart including faster recovery, less time away from work and home and cost savings to the woman and her employer and the National Health Service. Resources need to be made available to rapidly develop this service across the UK in order to better serve both patient and taxpayer.

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

    African Journals Online (AJOL)

    or hysteroscopy in AKTH within the study period were retrieved from the operation record book; their case files were retrieved, studied and recorded in a ... Key words: Anaesthesia; hysteroscopy; laparoscopy. Introduction. Laparoscopy and ... local anaesthesia with sedation may also be used for office laparoscopy.[3].

  8. Office Operative Hysteroscopy: An Update.

    Science.gov (United States)

    Salazar, Christina Alicia; Isaacson, Keith B

    2018-02-01

    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 © 2018. Published by Elsevier Inc.

  9. The diagnosis of chronic endometritis in infertile asymptomatic women: a comparative study of histology, microbial cultures, hysteroscopy, and molecular microbiology.

    Science.gov (United States)

    Moreno, Inmaculada; Cicinelli, Ettore; Garcia-Grau, Iolanda; Gonzalez-Monfort, Marta; Bau, Davide; Vilella, Felipe; De Ziegler, Dominique; Resta, Leonardo; Valbuena, Diana; Simon, Carlos

    2018-06-01

    Chronic endometritis is a persistent inflammation of the endometrial mucosa caused by bacterial pathogens such as Enterobacteriaceae, Enterococcus, Streptococcus, Staphylococcus, Mycoplasma, and Ureaplasma. Although chronic endometritis can be asymptomatic, it is found in up to 40% of infertile patients and is responsible for repeated implantation failure and recurrent miscarriage. Diagnosis of chronic endometritis is based on hysteroscopy of the uterine cavity, endometrial biopsy with plasma cells being identified histologically, while specific treatment is determined based on microbial culture. However, not all microorganisms implicated are easily or readily culturable needing a turnaround time of up to 1 week. We sought to develop a molecular diagnostic tool for chronic endometritis based on real-time polymerase chain reaction equivalent to using the 3 classic methods together, overcoming the bias of using any of them alone. Endometrial samples from patients assessed for chronic endometritis (n = 113) using at least 1 or several conventional diagnostic methods namely histology, hysteroscopy, and/or microbial culture, were blindly evaluated by real-time polymerase chain reaction for the presence of 9 chronic endometritis pathogens: Chlamydia trachomatis, Enterococcus, Escherichia coli, Gardnerella vaginalis, Klebsiella pneumoniae, Mycoplasma hominis, Neisseria gonorrhoeae, Staphylococcus, and Streptococcus. The sensitivity and specificity of the molecular analysis vs the classic diagnostic techniques were compared in the 65 patients assessed by all 3 recognized classic methods. The molecular method showed concordant results with histological diagnosis in 30 samples (14 double positive and 16 double negative) with a matching accuracy of 46.15%. Concordance of molecular and hysteroscopic diagnosis was observed in 38 samples (37 double positive and 1 double negative), with an accuracy of 58.46%. When the molecular method was compared to microbial culture

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

    Science.gov (United States)

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

    2017-12-01

    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.

  11. Transvaginal sonography in abnormal uterine bleeding and correlation to hysteroscopy

    International Nuclear Information System (INIS)

    Saeed, S.; Shah, S.; Ali, H.; Khan, S.; Ehsan, N.; Ahmed, S.Z.

    2017-01-01

    To correlate results of Transvaginal sonography with those of hysteroscopy and biopsy in abnormal uterine bleeding to estimate the accuracy and analytical values of non-invasive transvaginal sonography in abnormal uterine bleeding. Methodology: This cross-sectional Study was carried out at BMCH, Quetta, Balochistan, Pakistan from March 2013 to February 2014 and included 200 patients of abnormal uterine bleeding. Exclusion criteria were pregnancy, virginity, local bleeding of perineal or vaginal origin. Hysteroscopy and biopsy and Transvaginal Ultrasound (TVS) were performed in all. Result: The most common type of bleeding was found to be menorrhagia in 39% while the least common type was postmenopausal bleeding in 9%. Mean endometrial thickness was 11.64 mm and it was noted that at less than 14mm thickness no serious pathology was found. Sensitivity of TVS for endometrial hyperplasia was found to be 66.66% while specificity was 100%. Positive analytical value was 100% while negative value was 100%. Overall sensitivity calculated for TVS was 94.44%, specificity 98.55%, PPV was 81.93% and NPV 98.55%. Conclusion: Sensitivity and specificity of TVS were lower than hysteroscopy and biopsy but the difference was not significant. TVS can be used as first line investigation while hysteroscopy and biopsy may be left for cases of high risk or in those cases where some positive findings could be found on TVS. (author)

  12. ACOG Technology Assessment No. 13: Hysteroscopy.

    Science.gov (United States)

    2018-05-01

    Hysteroscopy is performed to view and treat pathology within the uterine cavity and endocervix. Diagnostic hysteroscopy allows visualization of the endocervical canal, endometrial cavity, and fallopian tube ostia. Operative hysteroscopy incorporates the use of mechanical, electrosurgical, or laser instruments to treat intracavitary pathology and perform hysteroscopic sterilization procedures. Selection of a distending medium requires consideration of the advantages, disadvantages, and risks associated with various media as well as their compatibility with electrosurgical or laser energy. A preoperative consultation allows the patient and physician to discuss the hysteroscopic procedure, weigh its inherent risks and benefits, review the patient's medical history for any comorbid conditions, and exclude pregnancy. Known pregnancy, genital tract infections, and active herpetic infection are contraindications to hysteroscopy. The most common perioperative complications associated with operative hysteroscopy are hemorrhage, uterine perforation, and cervical laceration. The procedure is minimally invasive and can be used with a high degree of safety.

  13. ACOG Technology Assessment No. 13 Summary: Hysteroscopy.

    Science.gov (United States)

    2018-05-01

    Hysteroscopy is performed to view and treat pathology within the uterine cavity and endocervix. Diagnostic hysteroscopy allows visualization of the endocervical canal, endometrial cavity, and fallopian tube ostia. Operative hysteroscopy incorporates the use of mechanical, electrosurgical, or laser instruments to treat intracavitary pathology and perform hysteroscopic sterilization procedures. Selection of a distending medium requires consideration of the advantages, disadvantages, and risks associated with various media as well as their compatibility with electrosurgical or laser energy. A preoperative consultation allows the patient and physician to discuss the hysteroscopic procedure, weigh its inherent risks and benefits, review the patient's medical history for any comorbid conditions, and exclude pregnancy. Known pregnancy, genital tract infections, and active herpetic infection are contraindications to hysteroscopy. The most common perioperative complications associated with operative hysteroscopy are hemorrhage, uterine perforation, and cervical laceration. The procedure is minimally invasive and can be used with a high degree of safety.

  14. Anti-adhesion barrier gels following operative hysteroscopy for treating female infertility: a systematic review and meta-analysis

    NARCIS (Netherlands)

    Bosteels, Jan; Weyers, Steven; Mol, Ben W. J.; D'Hooghe, Thomas

    2014-01-01

    The aim of this study was to assess the effects of any anti-adhesion barrier gel used after operative hysteroscopy for treating infertility associated with uterine cavity abnormalities. Gynecologists might use any barrier gel following operative hysteroscopy in infertile women for decreasing de novo

  15. Discrepancy between ultrasonography and hysteroscopy and histology of endometrium in postmenopausal breast cancer patients using tamoxifen

    NARCIS (Netherlands)

    Mourits, MJE; Van der Zee, AGJ; Willemse, PHB; Ten Hoor, KA; Hollema, H; De Vries, EGE

    Background. The increased risk of endometrial carcinoma following the use of tamoxifen has stimulated studies on endometrial diagnostic screening methods. In tamoxifen users the endometrial thickening observed with transvaginal ultrasonography (TVU) frequently cannot be confirmed by hysteroscopy or

  16. Are 3D ultrasound and office hysteroscopy useful for the assessment of uterine cavity after late foetal loss?

    Science.gov (United States)

    Thellier, E; Levaillant, J-M; Pourcelot, A-G; Houllier, M; Fernandez, H; Capmas, P

    2018-05-01

    To assess the efficacy of office hysteroscopy and 3D ultrasound for the diagnostic of uterine anomalies after late foetal loss. This retrospective observational study took place in the gynaecologic unit of a teaching hospital from 2009 to 2014. Women with late foetal loss (<22 weeks of gestation) had an office hysteroscopy and 3D ultrasound within three months after delivery. The results of the ultrasound and hysteroscopy were recorded and compared. Eighty women were included with a mean age of 29.8 years (28.2-31.4). Forty-seven women had both hysteroscopy and 3D ultrasound, and a uterine cavity's anomaly (bicornuate uterus, T-Shape uterus and septate uterus) was found in ten women (21%) at 3D sonography and in 13 women (28%) at office hysteroscopy. Concordance between the two exams was very good with a kappa at 0.83. In three cases, a uterine cavity's anomaly was found at hysteroscopy whereas sonography was normal. Anomalies at ultrasound (uterine cavity's anomaly, myometrium anomaly or ovarian anomaly) were found in 27.6% of cases. Both 3D ultrasound and office hysteroscopy are useful for assessment of the uterine cavity after late foetal loss. The application of these two exams is important, as hysteroscopy is generally used for assessment of the uterine cavity and endometrium, while 3D ultrasound is generally used to identify the precise type of uterine malformation and for the examination of the myometrium and annexes. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. [Hysteroscopy clinic: diagnostic and therapeutic method in abnormal uterine bleeding].

    Science.gov (United States)

    Alanis Fuentes, José; Obregón Zegarra, Eva Haydee

    2012-12-01

    Abnormal uterine bleeding is a public health problem prevalence exceeded only by abnormal vaginal discharge as a reason for medical consultation. To describe the findings reported by the Hysteroscopy clinic of the Hospital GEA Gonzalez on patients with Abnormal Uterine bleeding diagnosis. Retrospective, transversal, descriptive study. The total 2546 records of those patient that were evaluated by Office Hysteroscopic between January 2007 and December 2008 on the Hysteroscopy Clinic of Hospital Manuel GEA Gonzalez, then we selected the 1482 records of those patients that were sended because of an Abnormal Uterine bleeding condition. We descrive the frequencies of the diagnosis and its interrelation with the age of the patients. We also report the therapeutical interventions during office hysteroscopy. The mean age of the patients was 42.15 +/- 9.30 years (from 12 a 92 years); the age groups of patients that belonged to 40-44 years and 45-49 years are the most frequent patient and they represent the 25% y el 23.3% of the records. The abnormal findings occurred on the 66% de of the patients. Those patients of 65 years old and older do not have any report of normal cavities, all of then have abnormal findings. The leiomyoma (26.9%) and the endometrial polyps (27.3%) were the most frequent findings. The postmenopausal bleeding had a rate of 90.9% abnormal findings and in this group of patients the most frequent diagnosis was atrophic endometrium (32.2%) and polyps (24.3%). Besides that the office hysteroscopy show its therapeutical usefulness because of the 67% and 77.5% of polipectomy perform for endometrial and cervical polyps respectively The office Hysteroscopy is a well tolerated diagnosis and therapeutic method that is useful for any women with abnormal uterine bleeding condition and it is the ideal technique for the examination of abnormal uterine bleeding in postmenopausal women... The office hysteroscopy is a efficient cost-effective and cost-benefic method for

  20. Virtual Reality Hysteroscopy

    Science.gov (United States)

    Levy

    1996-08-01

    New interactive computer technologies are having a significant influence on medical education, training, and practice. The newest innovation in computer technology, virtual reality, allows an individual to be immersed in a dynamic computer-generated, three-dimensional environment and can provide realistic simulations of surgical procedures. A new virtual reality hysteroscope passes through a sensing device that synchronizes movements with a three-dimensional model of a uterus. Force feedback is incorporated into this model, so the user actually experiences the collision of an instrument against the uterine wall or the sensation of the resistance or drag of a resectoscope as it cuts through a myoma in a virtual environment. A variety of intrauterine pathologies and procedures are simulated, including hyperplasia, cancer, resection of a uterine septum, polyp, or myoma, and endometrial ablation. This technology will be incorporated into comprehensive training programs that will objectively assess hand-eye coordination and procedural skills. It is possible that by incorporating virtual reality into hysteroscopic training programs, a decrease in the learning curve and the number of complications presently associated with the procedures may be realized. Prospective studies are required to assess these potential benefits.

  1. Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB

    Directory of Open Access Journals (Sweden)

    Deeksha Pandey

    2017-11-01

    Full Text Available Introduction: Pattern recognition of various phases of normal endometrium and endometrial pathologies during hysteroscopy has many advantages. It would help to triage women with AUB, so as to be selective with biopsies and curettages. Recognition of normal variant or benign lesion would reduce burden to the pathologist by decreasing the number of unnecessary sampling. It will also decreases anxiety of the patient as the report/prognostication can be instant in many cases. Material and methods: This prospective, double blind, correlation study was carried out in the teaching hospital with a sample population of 70 women presenting with AUB who underwent hysteroscopy and endometrial sampling. We identified patterns of endometrium which can used to predict six endometrial pathologies which were later correlated with the final histological diagnosis. Results: There was good correlation between hysteroscopic patterns and histopathology report, 33% of starry sky appearance correlated with atrophic endometrium, 87% of tongue shaped projections correlated with endometrial polyp, 44.4% of pebble stone appearance correlated with myomatous polyp, 50% of polypoidal pattern correlated with endometrial hyperplasia. 100% correlation was seen in strawberry appearance, pattern for secretory endometrium and cerebroid appearance which was pattern designated to endometrial carcinoma. Conclusion: Hysteroscopic pattern recognition is a useful concept to triage women who require sampling for histopathological diagnosis. Keywords: Abnormal uterine bleeding, Histopathology, Hysteroscopy, Pattern recognition

  2. Diagnostic Accuracy of Transvaginal Sonography, Sonohysterography and Office Hysteroscopy in the Evaluation of Abnormal Uterine Bleeding

    Directory of Open Access Journals (Sweden)

    Ümit Göktolga

    2007-06-01

    Full Text Available OBJECTIVE: To find out the diagnostic accuracy of transvaginal sonography (TVS and saline infusion sonography (SIS by comparing the results with hysteroscopy (HSC and hystological reports obtained by endometrial biopsies in pre and postmenopausal women with abnormal uterine bleeding (AUB.\tDesign: Prospective study\tSetting: women presenting with abnormal uterine bleeeding as an outpatient procedure, in Gülhane Military Medical Faculty, between June 01, 2004 – August 01, 2005.\tPatients: 38 premenopausal and 6 postmenopausal patients\tInterventions: TVS and SIS was performed at the same seance and they underwent hysteroscopy and hysteroscopic biopsy one week later.\tMain outcome measures: The findings at TVS and SIS were compared with the hysteroscopic views and histologic findings. The sensitivity and spesifity ratios of all three methods were calculated in defining the endometrial and intracavitary pathologies.\tRESULTS: The sensitivity ratios of TVS and SIS in defining endometrial pathologies was 36.4% and 33.8% respectively and the sensitivity of hysteroscopy was lower. (%28.6, p=0.24 In the comparison of spesifity ratios sonohysterography had a higher ratio than others. (TVS vs SIS, p=0.08; HSC vs SIS, p=0.07 As a result; in outpatient group, hysteroscopy gives not much more information than SIS.\tThe detection rate of focal intrauterine pathology (polyp/submucous myoma using conventional TVS was significantly lower than sonohysterography. (sensitivity ratios; 46.5% and 97.1% respectively; p=0.0009 The sensitivity ratios of hysteroscopy (100% and SIS (97.1 was similar. (p=0.98\tCONCLUSIONS: Sonohysterography is a current, trustable method which can replace office hysteroscopy in the diagnosis and evaluation of cases presenting with AUB especially in outpatient group.

  3. Evaluation of pain in outpatient diagnostic hysteroscopy with gas

    Directory of Open Access Journals (Sweden)

    Daniela Barreto Fraguglia Quental Diniz

    2010-03-01

    Full Text Available Objective: To evaluate the intensity of pain reported by patients undergoing outpatient diagnostic hysteroscopy. Methods: Exam performed with a 5-mm lens hysteroscope, vaginal speculum, tenaculum and uterine distention with carbon dioxide gas. Before and after the examination, patients were interviewed to define, in a verbal scale from 0 to 10, pain values that they expected to feel and that they experienced after the end, and also if they would repeat it if indicated. Data were analyzed using Statistical Package for the Social Sciences 15.0, statistic significance was defined as p < 0.05 with a study power of 95%. Results: Fifty-eight patients were included with mean age of 50.9 years, with 32.8% at postmenopause and 6.9% nulliparous. Among those with previous deliveries, mean parity was 2.21 and at least one vaginal delivery had occurred in 63.8%. Only 24.1% of patients knew how the exam would be done, 62.1% needed an endometrial sample and the result was considered satisfactory in 89.7%. The means of expected and experienced pain were similar (6.0 versus 6.1, and 91.4% of women would repeat the hysteroscopy if necessary. The only factor associated with less pain after the exam was previous vaginal delivery, with a decrease of pain score from 7.1 to 5.5 (p = 0.03. Mean pain was significantly lower in those who agreed to repeat the exam (5.8 versus 9.4; p = 0.003. Conclusions: Outpatient diagnostic hysteroscopy with gas can be associated with moderate but tolerable discomfort and satisfactory results.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  6. The Danish Hysterectomy and Hysteroscopy Database

    DEFF Research Database (Denmark)

    Topsøe, Märta Fink; Ibfelt, Else Helene; Settnes, Annette

    2016-01-01

    AIM OF THE DATABASE: The steering committee of the Danish Hysterectomy and Hysteroscopy Database (DHHD) has defined the objective of the database: the aim is firstly to reduce complications, readmissions, reoperations; secondly to specify the need for hospitalization after hysterectomy; thirdly...... DATA: Annually approximately 4,300 hysterectomies and 3,200 operative hysteroscopies are performed in Denmark. Since the establishment of the database in 2003, 50,000 hysterectomies have been registered. DHHD's nationwide cooperation and research have led to national guidelines and regimes. Annual...... national meetings and nationwide workshops have been organized. CONCLUSION: The use of vaginal and laparoscopic hysterectomy methods has increased during the past decade and the overall complication rate and hospital stay have declined. The regional variation in operation methods has also decreased....

  7. Role of oral tramadol 50 mg in reducing pain associated with outpatient hysteroscopy: A randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Hassan, AbdelGany; Haggag, Hisham

    2016-02-01

    Several drugs have been used to reduce hysteroscopy-associated pain. Although the Royal College of Obstetricians and Gynaecologists has recommended against the use of opiates in outpatient hysteroscopy, we wished to investigate if opioids can be used if the appropriate opioid was given in the appropriate dose. To study the effectiveness of tramadol 50 mg in reducing pain associated with outpatient hysteroscopy. A prospective randomised double-blind placebo-controlled trial conducted in the outpatient hysteroscopy clinic at Cairo University Hospital. Main outcome measures were the severity of pain during the procedure, immediately after the procedure and 30 minutes later assessed by a visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible pain. A total of 140 women who had diagnostic outpatient hysteroscopy were randomised to receive oral tramadol 50 mg or placebo one h before performing outpatient hysteroscopy. There was no difference between the groups in the age, parity, duration of the procedures or indications of hysteroscopy. The median pain score was significantly lower in the tramadol group during the procedure (5 vs 6; P = 0.013), immediately after the procedure (3 vs 4; P pain evoked by the procedure and the drug was well tolerated by women. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  8. Experience of office hysteroscopy for diagnostics of abnormal uterine bleeding causes in puberty girls

    Directory of Open Access Journals (Sweden)

    Bezhanishvili Е.М.

    2016-09-01

    Full Text Available Objective: to prove the role of office hysteroscopy as an important additional method in diagnostics of puberty abnormal uterine bleeding (AUB. Material and methods. The study involved 68 patients with AUB. The average age was 13.4 years (10-17 years. The main complaint of patients concerned bleeding from genital tract during 10-45 days (on an average 28.4 days. Patients were divided into 3 groups according to the type of AUB determined based on the level of serum estradiol, physical and sexual development, internal genitalia ultrasound data: 35 hypo estrogenic girls, 24 girls with normal estrogenic and 9 girls with hyper estrogenic type of AUB. All of the girls took the office hysteroscopy. Results. When performing hysteroscopy it was revealed that there were a clear relationship between the degree of estrogenic saturation and visual picture obtained in the course of the study. Conclusion. Hysteroscopy enables maximum visualization of uterine cavity, which allows to verify the diagnosis, to reduce the "over diagnosis" rate of organic pathology, perform a differentiated approach to treatment of diseases, based on determination of estradiol level in serum and data obtained in the study.

  9. Role Of Hysteroscopy In The Evaluation Of Tubal Patency In Infertile Women

    International Nuclear Information System (INIS)

    Rashed, A.M.; Sweedan, Kh.H.; ElBishry, G.A.; Serag, I.F.; Ahmed, W.E.

    2012-01-01

    Purpose: To evaluate the effectiveness of hysteroscopy as a method for the diagnosis of tubal patency using saline distention media. Methods: In this prospective study, 64 infertile women underwent hysteroscopy (HSC) and hysterosalpingography (HSG) on two consecutive days. Transvaginal ultrasonography (TVS) carried out before and after hysteroscopy in order to measure the fluid in the cul-de-sac.The difference between the two methods in diagnosis of tubal patency was compared using laparoscopy/chromotubationas a gold standard. Fluid volume measurements were used to determine a cut off value for tubal patency. Pain was recorded at the end of the processes. Results: According to the laparoscopy, the sensitivity and specificity of HSC and HSG in detecting tubal patency were (94.6% and 100% vs 92.8% and 50%, respectively). The best cut off point of the fluid volume in the cul-de-sac at which both tubes are patent is 6 ml. All of the patients reported significantly less pain during hysteroscopy in response to HSG. Conclusions: office HSC combined with TVS may be used as an alternative to HSG in the diagnosis of tubal patency in an easy, rapid, safe way with minimal pain.

  10. The role of hysteroscopy in diagnosis and treatment of postmenopausal bleeding

    Directory of Open Access Journals (Sweden)

    Pop-Trajković-Dinić Sonja

    2013-01-01

    Full Text Available Background/Aim. Abnormal uterine bleeding is the most common problem which brings woman to the gynecologist during the postmenopausal period. The aim of this study was to define the significance of hysteroscopy as a diagnostic procedure for the evaluation of patients with postmenopausal bleeding, as well as to define it as a surgical procedure by which the cause of bleeding can be treated in most cases in the same sitting. Methods. The study involved 148 female patients referred to the Clinic for Gynecology and Obstetrics in Niš for postmenopausal bleeding in the period of 12 months. Hysteroscopy with endometrial biopsy were performed in all the patients. Biopsy materials were directed to histological examination, and the hysteroscopic and histological findings were compared afterwards. Polyps and submucous miomas were hysteroscopically removed in the same sitting and also directed to histological examination. Results. The success rate of the method was 95.1%, while complications occurred in 1.37% of the cases. The hysteroscopic findings were normal in almost 30% of the cases, and the most common pathological finding was endometrial polyp. The sensitivity of hysteroscopy in the detection of intrauterine pathology was 100%, the specificity 81%, the positive predictive value 92% and the negative predictive value 100%. In 69.7% of the patients the cause of bleeding was hysteroscopically removed. Hysteroscopy was performed in 58.1% of the patients in the same sitting, and in 11.6% of the patients after obtaining histological findings. Conclusion. Hysteroscopy is a safe, highly sensitive diagnostic procedure, thus being an ideal method for evaluation of patients with postmenopausal bleeding. The application of hysteroscopy with endometrial biopsy leads to accurate diagnosis. An adequate diagnosis is crucial for the selection of relevant treatment of postmenopausal bleeding and avoidance of unnecessary major surgical procedures. Except for being a

  11. 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 ...

  12. 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.

  13. The impact of altering filling pressures in diagnostic outpatient hysteroscopy on the procedure completion rates and associated pain: a randomised double-blind controlled trial.

    Science.gov (United States)

    Haggag, Hisham M; Hassan, AbdelGany M A

    2016-02-01

    Several studies have compared different distension media and analgesics to optimise the efficiency of outpatient hysteroscopy. However, studies comparing different uterine filling pressures are scarce. The objective of this study was to evaluate and compare different uterine filling pressures during diagnostic outpatient hysteroscopy in an attempt to find the optimal pressure allowing adequate visualisation while minimising pain and increasing patient satisfaction. This was a double-blind randomised controlled trial. A total of 240 women who had diagnostic outpatient hysteroscopy were randomly divided into three equal groups: the uterine filling pressure was 30 mm Hg in group 1, 50 mm Hg in group 2 and 80 mm Hg in group 3. The primary outcome was adequate visualisation, and secondary outcomes were the proportion of completed procedures, pain perceived during the procedure, immediately after the procedure and 30 min later. Adequate visualisation was lower in group 1 (88.7% vs 97.5% and 98.7%; P = 0.009), but was not different between groups 2 and 3 (P > 0.999). The proportion of completed procedures was not different among the groups. There was a progressive increase in pain scores from the lower to the higher pressure groups during the procedure, immediately after the procedure and 30 min after completing the procedure. Uterine filling pressure of 50 mm Hg was associated with better visualisation than 30 mm Hg and lower pain scores than that of 80 mmHg with no difference in the proportion of completed procedures. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  14. Preoperative ripening of the cervix before operative hysteroscopy.

    Science.gov (United States)

    Al-Fozan, Haya; Firwana, Belal; Al Kadri, Hanan; Hassan, Samar; Tulandi, Togas

    2015-04-23

    Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic. To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition. In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language. Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment. Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width

  15. [New in hysteroscopy: hysteroscopic morcellators].

    Science.gov (United States)

    Garbin, O; Schwartz, L

    2014-12-01

    A new technology recently appeared for the treatment of endo-uterine pathologies: hysteroscopic morcellators. It seemed to us useful to review this new technology. The morcellator we mostly experiment is the Myosure®, in 14 patients, with a median age of 40.5 years (28-58). The time of procedure went from 5 to 75 min with a median time at 26 min. The median of the total fluid deficit was 300 mL (0-1500 mL). A conversion in traditional resectoscopy happened in 4 cases (29%). This results are not so good as in literature. This is probably bound to one the learning curve but also the type of pathology. For the operative time, all the studies agree that hysteroscopic morcellation is faster than hysteroscopic resection. The quantity of fluid used is also lesser, as the deficit of fluid when the morcellator is used. The percentage of success to remove the pathology is high, close to 100% for the polyps and 92% for the submucous myomas. The indications are the polyps and the submucous myomas type 0 or 1. The morcellation of remnant trophoblastic tissues is also described and seems effective. Others indications, as the removal of uterine septum or cure of uterine synechias, are criticisable. In conclusion, hysteroscopic morcellators are probably a great progress for the cure of the endo-uterine pathologies. They cannot yet concurrence the hysterosopic resectoscopes for the treatment of big submucous myoma or those with a large intramyometrial involvement. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  16. Four years of experience in our clinic regarding hysteroscopies for abnormal uterine hemorrhages

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    Tina Bobei

    2018-05-01

    Full Text Available Introduction. Abnormal uterine hemorrhages (AUH are the most common symptom for presentation to gynecologist. Any uterine bleeding other than menstrual bleeding, which concerns the duration, frequency, quality or quantity of the bleeding is considered abnormal. Material and Methods. We realized a retrospective study based on medical records of the patients admitted for abnormal uterine hemorrhage at “Saint John” Emergency Clinical Hospital, “Bucur” Maternity between 2013 and 2016. From the patients with AUH, we focused on those who underwent hysteroscopies. Results. Our study included 146 patients. The age of patients varied from 22 to 71 years. Abnormal uterine bleeding was most prevalent among women of 40-50 years (20%, and the mean age was 42.65%. 82.88% from our patients had obstetrical history and only 17.12% didn’t give birth either as an option, or from primary or secondary infertility. 7.53% of the patients were hypertensive and 5.48% had endocrine pathology. All patients underwent diagnostic hysteroscopy and 4.79% patients therapeutic hysteroscopy. The therapeutic measures that were made are: hysteroscopic resection of the endometrium (47.3%, excision of polyps (36.99%, sinechiolysis (8.22% and myomectomy (2.71%. The diagnoses were 46.48% endometrial polyp, 13.7% intramural leiomyoma, 13.7% IUD (intrauterine device and 9.59% intrauterine synechiae, while 15.06% cumulated for uterine septum, endometrial hyperplasia, cervical polyp, foreign intrauterine bodies, secondary infertility, dysfunctional metrorrhagia. Conclusion. In patients with abnormal uterine hemorrhages, hysteroscopy provides the most accurate diagnosis and can reduce the burden of hysterectomy in many cases.

  17. Diagnostic value of saline contrast sonohysterography comparing with hysteroscopy for detecting endometrial abnormalities in women with abnormal uterine bleeding

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    Farzaneh Goharzad

    2011-01-01

    Full Text Available Background: Abnormal uterine bleeding is a common presentation of uterine abnormalities among premenopausal and postmenopausal women.Objective: To evaluate and compare the diagnostic accuracy of saline contrast sonohysterography and hysteroscopy for detecting the cause of abnormal uterine bleeding.Materials and Methods: A total of 65 women with abnormal uterine bleeding were enrolled in this study. A prior saline contrast sonohysetrography followed by a hysteroscopy was performed in all cases. Sensitivity, specificity, positive and negative predictive value and test accuracy were calculated.Results: As the most common abnormality, SCSH showed hyperplasia in 19 patients while hysteroscopy diagnosed polyp in 15 cases. A sensitivity of 73.3%, 71.4% and 90.9% were reported for polyp, hyperplasia and submucous myoma respectively whereas the specificity was calculated 96% for polyps, 82.3% for hyperplasia and 90.7% for submucous myoma.Conclusion: Comparing with hysteroscopy, sonohysterography showed a high sensitivity and specificity for detecting submucous myoma but not for endometrial polyp and endometrial hyperplasia

  18. Comparative study of vaginal danazol vs diphereline (a synthetic GnRH agonist) in the control of bleeding during hysteroscopic myomectomy in women with abnormal uterine bleeding: a randomized controlled clinical trial.

    Science.gov (United States)

    Sayyah-Melli, M; Bidadi, S; Taghavi, S; Ouladsahebmadarek, E; Jafari-Shobeiri, M; Ghojazadeh, M; Rahmani, V

    2016-01-01

    To compare the usefulness of vaginal danazol and diphereline in the management of intra-operative bleeding during hysteroscopy. Randomized controlled clinical trial. University hospital. One hundred and ninety participants of reproductive age were enrolled for operative hysteroscopy. Thirty women were excluded from the study. One hundred and sixty participants with submucous myomas were allocated at random to receive either vaginal danazol (200mg BID, 30 days before surgery) or intramuscular diphereline (twice with a 28-day interval). Severity of intra-operative bleeding, clarity of the visual field, volume of media, operative time, success rate for completion of operation and postoperative complications. Overall, 145 patients completed the study. In the danazol group, 78.1% of patients experienced no intra-operative uterine bleeding, and 21.9% experienced mild bleeding. In the diphereline group, 19.4% of patients experienced no intra-operative uterine bleeding, but mild, moderate and severe bleeding was observed in 31.9%, 45.8% and 2.8% of patients, respectively. The difference between the groups was significant (puterine bleeding during operative hysteroscopy. However, vaginal danazol provided a clearer visual field. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  1. Management of abnormal uterine bleeding – focus on ambulatory hysteroscopy

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    Kolhe S

    2018-03-01

    Full Text Available Shilpa Kolhe Ambulatory Gynaecology Unit, Royal Derby Hospital, Derby, UK Abstract: The rapid evolution in ambulatory hysteroscopy (AH has transformed the approach to diagnose and manage abnormal uterine bleeding (AUB. The medical management in primary care remains the mainstay for initial treatment of this common presentation; however, many women are referred to secondary care for further evaluation. To confirm the diagnosis of suspected intrauterine pathology, the traditional diagnostic tool of day case hysteroscopy and dilatation and curettage in a hospital setting under general anesthesia is now no longer required. The combination of ultrasound diagnostics and modern AH now allows thorough evaluation of uterine cavity in an outpatient setting. Advent of miniature hysteroscopic operative systems has revolutionized the ways in which clinicians can not only diagnose but also treat menstrual disorders such as heavy menstrual bleeding, intermenstrual bleeding and postmenopausal bleeding in most women predominantly in a one-stop clinic. This review discussed the approach to manage women presenting with AUB with a focus on the role of AH in the diagnosis and treatment of this common condition in an outpatient setting. Keywords: abnormal uterine bleeding, ambulatory hysteroscopy, endometrial polyps, one-stop clinic, vaginoscopic approach

  2. Investigating uterine disease in the bitch: uterine cannulation for cytology, microbiology and hysteroscopy.

    Science.gov (United States)

    Watts, J R; Wright, P J

    1995-05-01

    A technique for transcervical cannulation of the uterus of the bitch for the collection of samples for cytology and microbiology was developed. This technique involved passing a cannula into the uterus with the aid of an endoscope. The uterus was cannulated successfully in mature bitches (over 10 kg) 110 times in 144 attempts. Success of cannulation was influenced by the experience of the operator and ease of cannulation by the stage of the reproductive cycle, the size of the bitch and the type of cannula. Complications associated with the procedure were endometritis, vaginitis and vaginal tears. Uterine cannulation was generally possible in all bitches studied at all stages of the reproductive cycle. Techniques for the collection of samples from the uterus for cytology and microbiology and for the processing of samples for uterine cytology are outlined. Hysteroscopy was performed on seven occasions in post partum bitches and was found to be possible at least until day 17 after whelping.

  3. Does experience in hysteroscopy improve accuracy and inter-observer agreement in the management of abnormal uterine bleeding?

    Science.gov (United States)

    Bourdel, Nicolas; Modaffari, Paola; Tognazza, Enrica; Pertile, Riccardo; Chauvet, Pauline; Botchorishivili, Revaz; Savary, Dennis; Pouly, Jean Luc; Rabischong, Benoit; Canis, Michel

    2016-12-01

    Hysteroscopic reliability may be influenced by the experience of the operator and by a lack of morphological diagnostic criteria for endometrial malignant pathologies. The aim of this study was to evaluate the diagnostic accuracy and the inter-observer agreement (IOA) in the management of abnormal uterine bleeding (AUB) among different experienced gynecologists. Each gynecologist, without any other clinical information, was asked to evaluate the anonymous video recordings of 51 consecutive patients who underwent hysteroscopy and endometrial resection for AUB. Experts (>500 hysteroscopies), seniors (20-499 procedures) and junior (≤19 procedures) gynecologists were asked to judge endometrial macroscopic appearance (benign, suspicious or frankly malignant). They also had to propose the histological diagnosis (atrophic or proliferative endometrium; simple, glandulocystic or atypical endometrial hyperplasia and endometrial carcinoma). Observers were free to indicate whether the quality of recordings were not good enough for adequate assessment. IOA (k coefficient), sensitivity, specificity, predictive value and the likelihood ratio were calculated. Five expert, five senior and six junior gynecologists were involved in the study. Considering endometrial cancer and endometrial atypical hyperplasia, sensitivity and specificity were respectively 55.5 % and 84.5 % for juniors, 66.6 % and 81.2 % for seniors and 86.6 % and 87.3 % for experts. Concerning endometrial macroscopic appearance, IOA was poor for juniors (k = 0.10) and fair for seniors and experts (k = 0.23 and 0.22, respectively). IOA was poor for juniors and experts (k = 0.18 and 0.20, respectively) and fair for seniors (k = 0.30) in predicting the histological diagnosis. Sensitivity improves with the observer's experience, but inter-observer agreement and reproducibility of hysteroscopy for endometrial malignancies are not satisfying no matter the level of expertise. Therefore, an accurate and

  4. 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.; 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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  7. 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.

  8. Audit of operative hysteroscopies among infertile women in a resource-poor setting.

    Science.gov (United States)

    Ugboaja, Joseph O; Oguejiofor, Charlotte B; Ogelle, Onyecherelam M

    2018-04-01

    To evaluate the operative hysteroscopy procedures performed among infertile women at two hospitals in Nigeria. A prospective case series was undertaken among all patients with infertility who underwent operative hysteroscopy between November 2015 and April 2017. The outcome measures included the frequency and type of operative hysteroscopy and the reproductive outcome. The series included 159 women, 70.4% (n=112) of whom had abnormal findings at hysteroscopy. A total of 162 operative hysteroscopic procedures were performed; the most common procedures were adhesiolysis (76 [46.9%]), polypectomy (28 [17.3%]), and septum resection/incision (17 [10.5%]). The instruments used were mainly scissors (65 [40.1%]) and a resectoscope (52 [32.1%]). Complete removal of the lesions was achieved in 86.4% (n=140) of the procedures and a normal cavity in 87.0% (n=141). The complication rate was 6.8% (n=11); the most common complication was minor hemorrhage (5 [3.1%]). The main challenges included poor distention (10 [6.2%]) and poor vision (8 [4.9%]). Menstrual normalization was achieved in 64 (40.3%) of the patients, the cumulative pregnancy rate was 19.5% (n=31), and the live birth rate was 3.8% (n=6). Operative hysteroscopy was feasible and safe in the present resource-poor region. There is a need to build capacity for the performance of hysteroscopy to facilitate the management of infertility in the region. © 2017 International Federation of Gynecology and Obstetrics.

  9. Ultrasound assessment of endometrial cavity in perimenopausal women on oral progesterone for abnormal uterine bleeding: comparison of diagnostic accuracy of imaging with hysteroscopy-guided biopsy.

    Science.gov (United States)

    Dasgupta, Subhankar; Dasgupta, Shyamal; Sharma, Partha Pratim; Mukherjee, Amitabha; Ghosh, Tarun Kumar

    2011-11-01

    To investigate the effect of oral progesterone on the accuracy of imaging studies performed to detect endometrial pathology in comparison to hysteroscopy-guided biopsy in perimenopausal women on progesterone treatment for abnormal uterine bleeding. The study population comprised of women aged 40-55 years with complaints of abnormal uterine bleeding who were also undergoing oral progesterone therapy. Women with a uterus ≥ 12 weeks' gestation size, previous abnormal endometrial biopsy, cervical lesion on speculum examination, abnormal Pap smear, active pelvic infection, adnexal mass on clinical examination or during ultrasound scan and a positive pregnancy test were excluded. A transvaginal ultrasound followed by saline infusion sonography were done. On the following day, a hysteroscopy followed by a guided biopsy of the endometrium or any endometrial lesion was performed. Comparison between the results of the imaging study with the hysteroscopy and guided biopsy was done. The final analysis included 83 patients. For detection of overall pathology, polyp and fibroid transvaginal ultrasound had a positive likelihood ratio of 1.65, 5.45 and 5.4, respectively, and a negative likelihood ratio of 0.47, 0.6 and 0.43, respectively. For detection of overall pathology, polyp and fibroid saline infusion sonography had a positive likelihood ratio of 4.4, 5.35 and 11.8, respectively, and a negative likelihood ratio of 0.3, 0.2 and 0.15, respectively. In perimenopausal women on oral progesterone therapy for abnormal uterine bleeding, imaging studies cannot be considered as an accurate method for diagnosing endometrial pathology when compared to hysteroscopy and guided biopsy. © 2011 The Authors. Journal of Obstetrics and Gynaecology Research © 2011 Japan Society of Obstetrics and Gynecology.

  10. Integration and Validation of Hysteroscopy Simulation in the Surgical Training Curriculum.

    Science.gov (United States)

    Elessawy, Mohamed; Skrzipczyk, Moritz; Eckmann-Scholz, Christel; Maass, Nicolai; Mettler, Liselotte; Guenther, Veronika; van Mackelenbergh, Marion; Bauerschlag, Dirk O; Alkatout, Ibrahim

    The primary objective of our study was to test the construct validity of the HystSim hysteroscopic simulator to determine whether simulation training can improve the acquisition of hysteroscopic skills regardless of the previous levels of experience of the participants. The secondary objective was to analyze the performance of a selected task, using specially designed scoring charts to help reduce the learning curve for both novices and experienced surgeons. The teaching of hysteroscopic intervention has received only scant attention, focusing mainly on the development of physical models and box simulators. This encouraged our working group to search for a suitable hysteroscopic simulator module and to test its validation. We decided to use the HystSim hysteroscopic simulator, which is one of the few such simulators that has already completed a validation process, with high ratings for both realism and training capacity. As a testing tool for our study, we selected the myoma resection task. We analyzed the results using the multimetric score system suggested by HystSim, allowing a more precise interpretation of the results. Between June 2014 and May 2015, our group collected data on 57 participants of minimally invasive surgical training courses at the Kiel School of Gynecological Endoscopy, Department of Gynecology and Obstetrics, University Hospitals Schleswig-Holstein, Campus Kiel. The novice group consisted of 42 medical students and residents with no prior experience in hysteroscopy, whereas the expert group consisted of 15 participants with more than 2 years of experience of advanced hysteroscopy operations. The overall results demonstrated that all participants attained significant improvements between their pretest and posttests, independent of their previous levels of experience (p hysteroscopic skills, proving an adequate construct validation of the HystSim. Using the multimetric scoring system enabled a more accurate analysis of the performance of the

  11. Ambulatory hysteroscopy and its role in the management of abnormal uterine bleeding.

    Science.gov (United States)

    Cooper, Natalie A M; Robinson, Lynne L L; Clark, T Justin

    2015-10-01

    Hysteroscopy is now an ambulatory procedure, having moved from a conventional day-case operating theatre environment to the outpatient clinic setting. Outpatient hysteroscopy can be used as a diagnostic test and as a therapeutic modality for women presenting with abnormal uterine bleeding. In many cases women can be diagnosed and treated efficiently during a single hospital appointment. This article reviews the development of ambulatory hysteroscopy and how it should optimally be performed and implemented. The contemporary role of this technology for investigating and treating women with abnormal uterine bleeding is then discussed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Role of hysteroscopy in the evaluation of tubal patency in infertile women

    Directory of Open Access Journals (Sweden)

    Ihab Serag Allam

    2014-09-01

    Conclusions: Office hysteroscopy combined with TVS may be used as an alternative to HSG, as an effective, easy, safe and minimal invasive office procedure that can be offered as a first line method for the evaluation of the uterine cavity along with the tubes in infertile women.

  13. 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...

  14. Predictive values of the ultrasonographic findings of patients who underwent hysteroscopy on an outpatient basis at the Servicio de Ginecologia of Hospital Mexico in 2010

    International Nuclear Information System (INIS)

    Mena Bejarano, Nasser Yamal; Calvo Chaves, Luis Antonio

    2013-01-01

    Sensitivity, specificity and predictivity were determined for ultrasonographic findings of the endometrial cavity with the findings in the outpatient surgery program of the Servicio de Ginecologia of Hospital Mexico in 2010. The data were collected retrospectively by taking randomly a sample of the total of 147 patients with hysteroscopy. Data from selected clinical records are taken to perform statistical analysis using histories for the most frequent findings and to measure the diagnostic accuracy of both transvaginal econography and hysteroscopy. Necmar's 2x2 table is used, for to calculate the values of sensitivity, specificity, positive and negative and to obtain the comparative results. The ultrasonographic findings were: endometrial polipo 60%, endometrial thickening 20% and submucous myoma 11%. The postoperative diagnoses were: endometrial polyposis 65%, endometrial cavity without lesions 11%, submucous myoma 9%, endometrial hyperplasia 7% and endometrial atrophy 3%. Transvaginal ultrasound is proved to be an acceptable diagnostic method for endometrial polipo because it had a positive predictive value of 79%. In the submucous myoma, are found values of specificity and a very high negative predictive value, which indicates that ultrasound is actually able to rule out the presence of this pathology [es

  15. Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial

    NARCIS (Netherlands)

    Tasma, M L; Louwerse, M D; Hehenkamp, W J; Geomini, P M; Bongers, M Y; Veersema, S; van Kesteren, P J; Tromp, E; Huirne, J A; Graziosi, G C

    OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical

  16. Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding.

    Science.gov (United States)

    Kowalczyk, Dariusz; Guzikowski, Wojciech; Więcek, Jacek; Sioma-Markowska, Urszula

    2012-01-01

    In many publications the transvaginal ultrasound is regarded as the first step to diagnose the cause of uterine bleeding in perimenopausal women. In order to improve the sensitivity and specificity of the conventional ultrasound physiological saline solution was administered to the uterine cavity and after expansion of its walls the interior uterine cavity was examined. And this procedure is called 2D sonohysterography (SIS 2D). By the ultrasound scanners which enable to get 3D real time image a spatial evaluation of the uterine cavity is possible. Clinical value of the real time 3D sonohysterography and 2D sonohysterography compared to hysteroscopy with histopathological examination in perimenopausal women. The study concerned a group of 97 perimenopausal women with abnormal uterine bleeding. In all of them after a standard transvaginal ultrasonography a catheter was inserted into the uterine cavity. After expansion of the uterine walls by administering about 10 ml of 0,9% saline solution the uterine cavity was examined by conventional sonohysterography. Then a 3D imaging mode was activated and the uterine interior was examined by real time 3D ultrasonography. The ultrasound results were verified by hysteroscopy, the endometrial lesions were removed and underwent a histopathological examination. In two cases the SIS examination was impossible because of uterine cervix atresion. In the rest of examined group the SIS 2D sensitivity and specificity came up to 72 and 96% respectively. In the group of SIS 3D the sensitivity and specificity reached 83 and 99% respectively. Adding SIS 3D, a minimally invasive method, to conventional sonohysterography improves the precision of diagnosis of endometrial pathology, allows to get three-dimensional image of the uterine cavity and enables examination of endometrial lesions. The diagnostic precision of this procedure is similar to the results achieved by hysteroscopy.

  17. Does the addition of saline infusion sonohysterography to transvaginal ultrasonography prevent unnecessary hysteroscopy in premenopausal women with abnormal uterine bleeding?

    Science.gov (United States)

    Short, John; Sharp, Benjamin; Elliot, Nikki; McEwing, Rachael; McGeoch, Graham; Shand, Brett; Holland, Kieran

    2016-08-01

    This observational case series in 65 premenopausal women with abnormal uterine bleeding evaluated whether transvaginal ultrasound followed by saline infusion sonohysterography (SIS) prevented unnecessary hysteroscopy. Although SIS indicated that hysteroscopy was unnecessary in eight women, this benefit was offset by the invasive nature of the scan, the number of endometrial abnormalities falsely detected by SIS and the cost of the additional investigation. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  18. Comparison of saline infusion sonohysterography and hysteroscopy in diagnosis of premenopausal women with abnormal uterine bleeding.

    Science.gov (United States)

    Soguktas, Suna; Cogendez, Ebru; Kayatas, Semra Eser; Asoglu, Mehmet Resit; Selcuk, Selcuk; Ertekin, Aktug

    2012-03-01

    The aim of this study was to compare the diagnostic effectiveness of transvaginal sonography (TVS), saline infusion sonohysterography (SIS), and diagnostic hysteroscopy (HS), with the pathologic specimen as a gold standard diagnostic method, in detecting endometrial pathology in premenopausal women with abnormal uterine bleeding. This prospective cohort study was conducted at Zeynep Kamil Education and Training Hospital, Istanbul, Turkey, and included 89 premenopausal women. All participants were examined first by TVS, further investigated with SIS and HS, and finally dilatation and curettage was performed when needed. The results obtained from these three methods were compared with the pathologic diagnoses. The positive and negative likelihood ratios (LR+ and LR-) of TVS, SIS and HS were calculated by comparison with the final pathological diagnosis. In addition, area under the curve (AUC) values were also calculated. Polypoid lesion was the most common abnormal pathology. LR+ and LR- of TVS, SIS, and HS were 3.13 and 0.15, 9.83 and 0.07, 13.7 and 0.02 respectively in detection of any abnormal pathology, and the AUCs of TVS, SIS, and HS were 0.804, 0.920, and 0.954 respectively. When the three procedures were compared with each other separately, HS had the best diagnostic accuracy, and the diagnostic accuracy of HS and SIS was superior to TVS (p(1)=0.000, p(2)=0.000). For the detection of polypoid lesions, HS was the most accurate diagnostic procedure (AUC=0.947), followed by SIS (AUC=0.894) and TVS (AUC=0.778). HS provides the most accurate diagnosis and allows treatment in the same session in premenopausal women with abnormal uterine bleeding. Published by Elsevier Ireland Ltd.

  19. Removal of Retained Adherent Placental Remnants Using the Hysteroscopy Endo-Operative System.

    Science.gov (United States)

    Zhu, Ke-An; Huang, Huan; Xue, Min; Subedi, Jigyasa; Jamail, Grace; Zhao, Weidong; Xu, Dabao; Xiao, Songshu

    2016-01-01

    Removal of retained adherent placental remnants (RAPRs) may be challenging using traditional 5Fr or 7Fr hysteroscopic grasping forceps because they are very small. This is particularly true when the retained placental remnant is large. This video demonstrates the advantages of using the Hysteroscopy Endo-Operative System (HEOS), a specially designed operative hysteroscope with a 13Fr working channel, to remove retained placental remnants. Step-by-step explanation of the technique using videos and pictures (educative video) (Canadian Task Force Classification III). Third Xiangya Hospital of Central South University, Hunan, China. A 32-year-old woman was diagnosed with RAPRs 5 weeks after the evacuation of retained placenta after a spontaneous abortion at 16 weeks' gestation. Gynecologic examination revealed an anterior 8-week uterus and no tenderness. Serum β-human chorionic gonadotropin was 150 mIU/L. Sonography revealed an irregular intrauterine mass, 3.5 cm × 3.5 cm × 3 cm in size. Removal of RAPRs using HEOS (Sopro-comeg Company, Bordeaux, France). The operation time was only 12 minutes. The RAPRs were removed completely and quickly in 1 procedure with no complications. The serum β-human chorionic gonadotropin titer normalized 1 week after the procedure. This study was approved by the institutional review board of the Third Xiangya Hospital of Central South University. When indicated, removal of RAPRs using HEOS is safe and simple because of its large and strong cold forceps. Additionally, it avoids electrical and thermal injury to the endometrium, which is particularly important in a population that wants to preserve fertility. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

  20. Clinical application of Lin's biopsy grasper for intrauterine targeted biopsy and polypectomy during office hysteroscopy.

    Science.gov (United States)

    Cheng, Hsin-Yi; Lin, Bao-Liang; Tseng, Jen-Yu; Ueno, Kazunori; Nakada, Sakura

    2018-06-01

    Hysteroscopy has widely been used for diagnosis of the uterine cavity; however, target biopsy has often been difficult in part to the inherent limitations of ancillary instruments. Lin's biopsy grasper was specifically designed to work in conjunction with a flexible hysteroscope to obtain intrauterine biopsy under transabdominal sonography. Herein, we share our clinical experience in the management of endometrial abnormalities with the use of Lin's biopsy grasper during office-based hysteroscopy. From February 2006 to November 2016, the use of Lin's biopsy grasper for tissue biopsy was attempted on 126 cases. We retrospectively recorded and analyzed the patients' preoperative characteristics and biopsy outcomes to demonstrate the feasibility and efficacy of Lin's biopsy grasper. Out of the one hundred and twenty-six enrolled patients, satisfactory targeted biopsies were achieved; including high diagnostic rate (92.1%, with 116 cases confirmed histologically) and adequate tissue retrieval (77.8%, with 98 cases obtaining optimal specimen volume). All patients tolerated the procedure without analgesics or anesthesia. Diagnostic flexible hysteroscopy combined with the use of Lin's biopsy grasper has proven to be an effective tool for intrauterine evaluation and obtaining tissue sample. Copyright © 2018. Published by Elsevier B.V.

  1. 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.

  2. Operative and diagnostic hysteroscopy: A novel learning model combining new animal models and virtual reality simulation.

    Science.gov (United States)

    Bassil, Alfred; Rubod, Chrystèle; Borghesi, Yves; Kerbage, Yohan; Schreiber, Elie Servan; Azaïs, Henri; Garabedian, Charles

    2017-04-01

    Hysteroscopy is one of the most common gynaecological procedure. Training for diagnostic and operative hysteroscopy can be achieved through numerous previously described models like animal models or virtual reality simulation. We present our novel combined model associating virtual reality and bovine uteruses and bladders. End year residents in obstetrics and gynaecology attended a full day workshop. The workshop was divided in theoretical courses from senior surgeons and hands-on training in operative hysteroscopy and virtual reality Essure ® procedures using the EssureSim™ and Pelvicsim™ simulators with multiple scenarios. Theoretical and operative knowledge was evaluated before and after the workshop and General Points Averages (GPAs) were calculated and compared using a Student's T test. GPAs were significantly higher after the workshop was completed. The biggest difference was observed in operative knowledge (0,28 GPA before workshop versus 0,55 after workshop, pvirtual reality simulation is an efficient model not described before. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. 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.

  4. Using narrow-band imaging with conventional hysteroscopy increases the detection of chronic endometritis in abnormal uterine bleeding and postmenopausal bleeding.

    Science.gov (United States)

    Ozturk, Mustafa; Ulubay, Mustafa; Alanbay, Ibrahim; Keskin, Uğur; Karasahin, Emre; Yenen, Müfit Cemal

    2016-01-01

    A preliminary study was designed to evaluate whether a narrow-band imaging (NBI) endoscopic light source could detect chronic endometritis that was not identifiable with a white light hysteroscope. A total of 86 patients with endometrial pathology (71 abnormal uterine bleeding and 15 postmenopausal bleeding) were examined by NBI endoscopy and white light hysteroscopy between February 2010 and February 2011. The surgeon initially observed the uterine cavity using white light hysteroscopy and made a diagnostic impression, which was recorded. Subsequently, after pressing a button on the telescope, NBI was used to reevaluate the endometrial mucosa. The median age of the patients was 40 years (range: 30-60 years). Endometritis was diagnosed histologically. Six cases of abnormal uterine bleeding (6/71, 8.4%, 95% confidence interval [CI] 0.03-0.17) and one case of postmenopausal bleeding (1/15, 6%, 95%CI 0.01-0.29) were only diagnosed with chronic endometritis by NBI (7/86, 8.1%, 95%CI 0.04-0.15). Capillary patterns of the endometrium can be observed by NBI and this method can be used to assess chronic endometritis. © 2015 Japan Society of Obstetrics and Gynecology.

  5. Systematic versus random sampling in stereological studies.

    Science.gov (United States)

    West, Mark J

    2012-12-01

    The sampling that takes place at all levels of an experimental design must be random if the estimate is to be unbiased in a statistical sense. There are two fundamental ways by which one can make a random sample of the sections and positions to be probed on the sections. Using a card-sampling analogy, one can pick any card at all out of a deck of cards. This is referred to as independent random sampling because the sampling of any one card is made without reference to the position of the other cards. The other approach to obtaining a random sample would be to pick a card within a set number of cards and others at equal intervals within the deck. Systematic sampling along one axis of many biological structures is more efficient than random sampling, because most biological structures are not randomly organized. This article discusses the merits of systematic versus random sampling in stereological studies.

  6. Assessment of reproductive results of infertile patients who had undergone operative hysteroscopy for intrauterine pathology

    Directory of Open Access Journals (Sweden)

    Röyale Seferli

    2015-03-01

    Full Text Available Objectives: We aimed to evaluate the reproductive outcomes of infertile patients who had undergone operative hysteroscopy (HS with the diagnoses of uterine septum, endometrial polyp, submucous myoma, and intrauterine adhesion. Methods: This retrospective study included 334 patients who had been diagnosed with primary and secondary infertility, aged between 18–35 years and diagnosed with uterine septum (group 1, endometrial polyp (group 2, submucous myoma (group 3, and intrauterine adhesion (group 4 by hysterosalpingography or office HS and who were treated via hysteroscopic operation between January 2009 and January 2013. Pregnancy results were obtained from the patients’ files and hospital database; when this was not possible, the patients were queried by phone calls. Groups were then compared in terms of characteristics, prognoses, and pregnancy outcomes. Results: The cumulative pregnancy rate was 58.7% in infertile patients who underwent operative HS due to intrauterine pathology. The mean length of time from operation to conception was 10.8±9.6 months in all groups. Mean age, infertility duration, infertility type, and smoking status were statistically different among the groups (p<0.05. Following surgery, 95 (66.4% of 143 patients in group 1 conceived and 57 (60% of these pregnancies resulted in term birth. There were 64 (54.2% pregnancies in group 2 and 34 (53.1% resulted in term birth. Sixteen (47.1% patients conceived in group 3, and 6 (37.5% of them had term birth. Twenty-one (53.8% patients conceived in group 4. Twelve out of 21 patients (57.1% had term birth. The most common mode of delivery was cesarean section in all groups. Conclusion: Thus, operative HS increases pregnancy rates in patients with intrauterine pathology. In future, large-scale prospective studies should be carried out to reveal the effects of the hysteroscopic method and compare this approach with other methods in order to achieve better pregnancy outcomes in

  7. Combined hyponatremia and hypocalcemia after intravascular absorption of 1.5% glycine during operative hysteroscopy. A case report

    OpenAIRE

    Sherif S. Sultan

    2016-01-01

    Intravascular absorption of distending media may complicate operative hysteroscopy. Consequences differ according to type, amount and speed of absorption of the distending media. We report a case of intravascular absorption of more than one liter of 1.5% glycine. A 36 years old female developed metabolic acidosis, hyponatremia and hypocalcemia during operative hysteroscopy scheduled for resection of a uterine fibroid. Serum sodium reached down to 119 mmol/l and ionized calcium to 0.898 mmol/l...

  8. 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.

  9. Combined hyponatremia and hypocalcemia after intravascular absorption of 1.5% glycine during operative hysteroscopy. A case report

    Directory of Open Access Journals (Sweden)

    Sherif S. Sultan

    2016-07-01

    Full Text Available Intravascular absorption of distending media may complicate operative hysteroscopy. Consequences differ according to type, amount and speed of absorption of the distending media. We report a case of intravascular absorption of more than one liter of 1.5% glycine. A 36 years old female developed metabolic acidosis, hyponatremia and hypocalcemia during operative hysteroscopy scheduled for resection of a uterine fibroid. Serum sodium reached down to 119 mmol/l and ionized calcium to 0.898 mmol/l. Serial estimations of arterial blood gases and serum electrolytes were followed. Management was successful in preventing serious side effects. Meticulous monitoring of distending media input/output balance remains the cornerstone in prevention of intravascular absorption.

  10. [Effects of the combined therapy of heat sensitive moxibustion and acupoint injection on endometrial receptivity of hypdrosalphinx infertility in the patients after hysteroscopy and laparoscopy].

    Science.gov (United States)

    Liu, Yanling; Pan, Lizhen; Wang, Ying

    2018-01-12

    To explore the effects of the combined therapy of heat sensitive moxibustion and acupoint injection on endometrial receptivity of hypdrosalphinx infertility in the patients after hysteroscopy and laparoscopy on the base of routine post-operative anti-inflammation. A total of 210 patients of hypdrosalphinx infertility after hysteroscopy and laparoscopy were divided into a combined therapy group, a heat sensitive moxibustion group and a control group, 70 cases in each one according to the random number table. In the control group, the intravenous drip of cefoxitin sodium was adopted, and the anti-inflammation treatment was given for 1 week after operation. In the heat sensitive moxibustion group, on the basis of the treatment as the control group, the heat sensitive moxibustion was applied after vaginal bleeding stopped. The acupoints were Yaoyangguan (GV 3), Guanyuan (CV 4), Qihai (CV 6), Shenshu (BL 23), Sanyinjiao (SP 6), Yinlingquan (SP 9) and Zigong (EX-CA1). The acupoints were modified according to the different syndromes. In the combined therapy group, on the basis of the regimen as the heat sensitive moxibustion group, after vaginal bleeding stopped, the acupoint injection was given alternatively at bilateral Tiangong (extra, 1.0 cm inferior and bilateral to the cervix) with lidocaine 1 mL, amikacin 2 mL and salvia injection 2 mL. The treatment was given once every day, the treatment for 10 times as one course and a total of 3 courses were required. The endometrial type, thickness, uterine arterial plusatility index (PI) and resistance index (RI) were observed in the patients of each group. After treatment, the numbers of A-type endometrial type in the combined therapy group and the heat sensitive moxibustion group were remarkably higher than those of the control group [57.1% (40/7) vs 31.4% (22/70), 50.0% (35/70) vs 31.4% (22/70), both P <0.05]. The endometrial thickness after treatment was all increased as compared with that before treatment in each group

  11. 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

  12. A systematic review and meta-analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions.

    Science.gov (United States)

    Li, Chunbo; Dai, Zhiyuan; Gong, Yuping; Xie, Bingying; Wang, Bei

    2017-01-01

    Results on the efficacy of hysteroscopic morcellation for patients with endometrial lesions remain conflicting. To compare hysteroscopic morcellation with conventional resectoscopy for removal of endometrial lesions. Electronic databases were searched for reports published up to February 1, 2016, using terms such as "morcellator," "morcellators," "morcellate," "morcellation," "morcellated," "hysteroscopy," "hysteroscopy," "uteroscope," and "transcervical." Randomized controlled trials were included if they assessed success rate, procedure speed, complications, tolerability, and/or learning curve. Data were extracted by two independent reviewers and a meta-analysis was performed. Four trials including 392 patients were analyzed. Successful removal of all endometrial lesions was more frequent with hysteroscopic morcellation than conventional resectoscopy (odds ratio 4.49, 95% confidence interval [CI] 1.94-10.41; Physteroscopic morcellation (mean difference -4.94 minutes, 95% CI -7.20 to -2.68; Plearning curve. In one study, hysteroscopic morcellation was acceptable to more patients (P=0.009). Hysteroscopic morcellation is associated with a higher operative success rate and a shorter operative time among patients with endometrial lesions than is resectoscopy. More high-quality trials are required to validate these results. © 2016 International Federation of Gynecology and Obstetrics.

  13. Experimental percolation studies of random networks

    Science.gov (United States)

    Feinerman, A.; Weddell, J.

    2017-06-01

    This report establishes an experimental method of studying electrically percolating networks at a higher resolution than previously implemented. This method measures the current across a conductive sheet as a function of time as elliptical pores are cut into the sheet. This is done utilizing a Universal Laser System X2-600 100 W CO2 laser system with a 76 × 46 cm2 field and 394 dpc (dots/cm) resolution. This laser can cut a random system of elliptical pores into a conductive sheet with a potential voltage applied across it and measures the current versus time. This allows for experimental verification of a percolation threshold as a function of the ellipse's aspect ratio (minor/major diameter). We show that as an ellipse's aspect ratio approaches zero, the percolation threshold approaches one. The benefit of this method is that it can experimentally measure the effect of removing small pores, as well as pores with complex geometries, such as an asterisk from a conductive sheet.

  14. Numerical study of microphase separation in gels and random media

    International Nuclear Information System (INIS)

    Uchida, Nariya

    2004-01-01

    Microphase separation in gels and random media is numerically studied using a Ginzburg-Landau model. A random field destroys long-range orientational (lamellar) order and gives rise to a disordered bicontinuous morphology. The dependence of the correlation length on the field strength is distinct from that of random-field magnets

  15. 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.

  16. Combined hysteroscopy-laparoscopy approach for excision of pelvic nitinol fragment from Essure contraceptive device: Role of intraoperative fluoroscopy for uterine conservation.

    Science.gov (United States)

    Sills, E Scott; Palermo, Gianpiero D

    2016-07-01

    We describe the successful removal of a pelvic contraceptive coil in a symptomatic 46-year-old patient who had Essure devices for four years, using a combined hysteroscopy-laparoscopy-fluoroscopy approach. Following normal hysteroscopy, at laparoscopy the right Essure implant was disrupted and its outer nitinol coil had perforated the fallopian tube. However, the inner rod (containing polyethylene terephthalate) had migrated to an extrapelvic location, near the proximal colon. In contrast, the left implant was situated within the corresponding tube. Intraoperative fluoroscopy was used to confirm complete removal of the device, which was further verified by postoperative computed tomography. The patient's condition improved after surgery and she continues to do well. This is the first report to describe this technique in managing Essure complications remote from time of insertion. Our case highlights the value and limitations of preoperative and intraoperative imaging to map Essure fragment location before surgery.

  17. Preoperative Diagnosis of Fallopian Tube Malignancy with Transvaginal Color Doppler Ultrasonography and Magnetic Resonance Imaging after Negative Hysteroscopy for Postmenopausal Bleedin

    OpenAIRE

    Arko, Darja; Žegura, Branka; Virag, Mirjana; Fokter Dovnik, Nina; Takač, Iztok

    2014-01-01

    Primary Fallopian tube carcinoma is a rare malignancy and is not often diagnosed preoperatively. We present a case of a 67-year old woman who complained of postmenopausal vaginal bleeding. After a negative hysteroscopy, transvaginal ultrasound showed a well vascularized solid-cystic tumor in the adnexal region separate from the ovary. The presence of an adnexal mass was confirmed by MR imaging. Total abdominal hysterectomy with bilateral salpingoophorectomy, omentectomy and appendectomy, as w...

  18. 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...

  19. Study on random number generator in Monte Carlo code

    International Nuclear Information System (INIS)

    Oya, Kentaro; Kitada, Takanori; Tanaka, Shinichi

    2011-01-01

    The Monte Carlo code uses a sequence of pseudo-random numbers with a random number generator (RNG) to simulate particle histories. A pseudo-random number has its own period depending on its generation method and the period is desired to be long enough not to exceed the period during one Monte Carlo calculation to ensure the correctness especially for a standard deviation of results. The linear congruential generator (LCG) is widely used as Monte Carlo RNG and the period of LCG is not so long by considering the increasing rate of simulation histories in a Monte Carlo calculation according to the remarkable enhancement of computer performance. Recently, many kinds of RNG have been developed and some of their features are better than those of LCG. In this study, we investigate the appropriate RNG in a Monte Carlo code as an alternative to LCG especially for the case of enormous histories. It is found that xorshift has desirable features compared with LCG, and xorshift has a larger period, a comparable speed to generate random numbers, a better randomness, and good applicability to parallel calculation. (author)

  20. 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.

  1. Thromboembolism and mechanical heart valves : A randomized study revisited

    NARCIS (Netherlands)

    Kuntze, CEE; Blackstone, EH; Ebels, T

    Background. This study was designed to revise and substantiate previous inferences, based on short-term follow-up, about differences in the incidence of anticoagulant-related events after heart valve replacement among patients who had been randomly assigned to receive either a Bjork-Shiley,

  2. Preoperative diagnosis of fallopian tube malignancy with transvaginal color doppler ultrasonography and magnetic resonance imaging after negative hysteroscopy for postmenopausal bleeding.

    Science.gov (United States)

    Arko, Darja; Žegura, Branka; Virag, Mirjana; Fokter Dovnik, Nina; Takač, Iztok

    2014-09-01

    Primary fallopian tube carcinoma is a rare malignancy and is not often diagnosed preoperatively. We present a case of a 67-year-old woman who complained of postmenopausal vaginal bleeding. After a negative hysteroscopy, transvaginal ultrasound showed a well vascularized solid-cystic tumor in the adnexal region separate from the ovary. The presence of an adnexal mass was confirmed by MR imaging. Total abdominal hysterectomy with bilateral salpingoophorectomy, omentectomy and appendectomy, as well as pelvic and paraaortic lymphadenectomy was performed. The pathohistological diagnosis was poorly differentiated serous adenocarcinoma of the fallopian tube, FIGO stage IA. The patient was subsequently treated with platinum based adjuvant chemotherapy.

  3. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

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

    Directory of Open Access Journals (Sweden)

    Nawar Shara

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

  5. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  6. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  7. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  8. 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.

  9. 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 ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  10. 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 SMD ... 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...

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

    Science.gov (United States)

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

    2012-08-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

  12. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    Science.gov (United States)

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

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  13. 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

  14. 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

  15. Feasibility of exercising adults with asthma: a randomized pilot study

    Directory of Open Access Journals (Sweden)

    Boyd Amy

    2012-08-01

    Full Text Available Abstract Background Aerobic exercise appears to have clinical benefits for many asthmatics, yet a complete understanding of the mechanisms underlying these benefits has not been elucidated at this time. Purpose The objective of this study was to determine feasibility for a larger, future study that will define the effect of aerobic exercise on cellular, molecular, and functional measures in adults with mild-moderate asthma. Design Recruited subjects were randomized into usual care (sedentary or usual care with moderate intensity aerobic exercise treatment groups. Setting / Participants Nineteen adults with mild-moderate asthma but without a recent history of exercise were recruited at the UAB Lung Health Center, Birmingham, AL. Intervention The exercise group underwent a 12 week walking program exercising at 60 – 75% of maximum heart rate (HRmax. Subjects self-monitored HRmax levels using heart rate monitors; exercise diaries and recreation center sign-in logs were also used. Main outcome measures Functional measures, including lung function and asthma control scores, were evaluated for all subjects at pre- and post-study time-points; fitness measures were also assessed for subjects in the exercise group. Peripheral blood and nasal lavage fluid were collected from all subjects at pre- and post-study visits in order to evaluate cellular and molecular measures, including cell differentials and eosinophilic cationic protein (ECP. Results Sixteen subjects completed the prescribed protocol. Results show that subjects randomized to the exercise group adhered well (80% to the exercise prescription and exhibited a trend toward improved fitness levels upon study completion. Both groups exhibited improvements in ACQ scores. No changes were observed in lung function (FEV1, FEV1/FVC, cell differentials, or ECP between groups. Conclusions Results indicate that a moderate intensity aerobic exercise training program may improve asthma control and fitness

  16. 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.

  17. People's Intuitions about Randomness and Probability: An Empirical Study

    Science.gov (United States)

    Lecoutre, Marie-Paule; Rovira, Katia; Lecoutre, Bruno; Poitevineau, Jacques

    2006-01-01

    What people mean by randomness should be taken into account when teaching statistical inference. This experiment explored subjective beliefs about randomness and probability through two successive tasks. Subjects were asked to categorize 16 familiar items: 8 real items from everyday life experiences, and 8 stochastic items involving a repeatable…

  18. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-10-15

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

  19. 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.

  20. Balneotherapy for chronic low back pain: a randomized, controlled study.

    Science.gov (United States)

    Kesiktas, Nur; Karakas, Sinem; Gun, Kerem; Gun, Nuran; Murat, Sadiye; Uludag, Murat

    2012-10-01

    A large number of treatments were used for patients with chronic low back pain. Frequent episodes have been reported very high. Although balneotherapy was found effective in this disease, there are not well-designed studies. We aimed to determine the effectiveness of balneotherapy versus physical therapy in patients with chronic low back pain. Exercise was added to both treatment programs. Sixty patients with chronic low back pain were randomly divided into two groups. Physical modalities plus exercise were applied to group 1, and group 2 was received balneotherapy plus exercise for ten sessions. The following parameters were measured: visual analogue scale at rest and movement for pain, paracetamol dose, manual muscle test for lumber muscles, modified Schoeber' test, Oswestry disability index, and Short-Form 36 at the beginning and end of the therapies and at the 3 months follow-up. The statistical analyses were performed using the SPSS 10.0 program. Both groups achieved significant improvements within themselves. But balneotherapy groups were improved at back extensor muscle test (P Balneotherapy combined with exercise therapy had advantages than therapy with physical modalities plus exercise in improving quality of life and flexibility of patients with chronic low back pain.

  1. Application of the random coil index to studying protein flexibility

    Energy Technology Data Exchange (ETDEWEB)

    Berjanskii, Mark V.; Wishart, David S. [University of Alberta, Department of Computing Science (Canada)], E-mail: david.wishart@ualberta.ca

    2008-01-15

    Protein flexibility lies at the heart of many protein-ligand binding events and enzymatic activities. However, the experimental measurement of protein motions is often difficult, tedious and error-prone. As a result, there is a considerable interest in developing simpler and faster ways of quantifying protein flexibility. Recently, we described a method, called Random Coil Index (RCI), which appears to be able to quantitatively estimate model-free order parameters and flexibility in protein structural ensembles using only backbone chemical shifts. Because of its potential utility, we have undertaken a more detailed investigation of the RCI method in an attempt to ascertain its underlying principles, its general utility, its sensitivity to chemical shift errors, its sensitivity to data completeness, its applicability to other proteins, and its general strengths and weaknesses. Overall, we find that the RCI method is very robust and that it represents a useful addition to traditional methods of studying protein flexibility. We have implemented many of the findings and refinements reported here into a web server that allows facile, automated predictions of model-free order parameters, MD RMSF and NMR RMSD values directly from backbone {sup 1}H, {sup 13}C and {sup 15}N chemical shift assignments. The server is available at http: //wishart.biology.ualberta.ca/rcihttp://wishart.biology.ualberta.ca/rci.

  2. 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.

  3. 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.

  4. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  5. Random-Number Generator Validity in Simulation Studies: An Investigation of Normality.

    Science.gov (United States)

    Bang, Jung W.; Schumacker, Randall E.; Schlieve, Paul L.

    1998-01-01

    The normality of number distributions generated by various random-number generators were studied, focusing on when the random-number generator reached a normal distribution and at what sample size. Findings suggest the steps that should be followed when using a random-number generator in a Monte Carlo simulation. (SLD)

  6. The High/Scope Perry Preschool Study: A Case Study in Random Assignment.

    Science.gov (United States)

    Schweinhart, Lawrence J.

    2000-01-01

    Studied the long-term benefits of preschool programs for young children living in poverty in the High/Scope Perry Preschool Study, which examined the lives of 123 African Americans randomly divided into a preschool treatment group and a no-preschool comparison group. Cost-benefit analyses of data on these students to age 27 show beneficial effects…

  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. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  9. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  10. 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.

  11. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

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

    Science.gov (United States)

    Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

    2017-01-01

    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.

  13. 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.

  14. A Study on the Amount of Random Graph Groupies

    OpenAIRE

    Lu, Daodi

    2013-01-01

    In 1980, Ajtai, Komlos and Szemer{\\'e}di defined "groupie": Let $G=(V,E)$ be a simple graph, $|V|=n$, $|E|=e$. For a vertex $v\\in V$, let $r(v)$ denote the sum of the degrees of the vertices adjacent to $v$. We say $v\\in V$ is a {\\it groupie}, if $\\frac{r(v)}{\\deg(v)}\\geq\\frac{e}{n}.$ In this paper, we prove that in random graph $B(n,p)$, $0

  15. Simulation and study of small numbers of random events

    Science.gov (United States)

    Shelton, R. D.

    1986-01-01

    Random events were simulated by computer and subjected to various statistical methods to extract important parameters. Various forms of curve fitting were explored, such as least squares, least distance from a line, maximum likelihood. Problems considered were dead time, exponential decay, and spectrum extraction from cosmic ray data using binned data and data from individual events. Computer programs, mostly of an iterative nature, were developed to do these simulations and extractions and are partially listed as appendices. The mathematical basis for the compuer programs is given.

  16. Inverse probability weighting for covariate adjustment in randomized studies.

    Science.gov (United States)

    Shen, Changyu; Li, Xiaochun; Li, Lingling

    2014-02-20

    Covariate adjustment in randomized clinical trials has the potential benefit of precision gain. It also has the potential pitfall of reduced objectivity as it opens the possibility of selecting a 'favorable' model that yields strong treatment benefit estimate. Although there is a large volume of statistical literature targeting on the first aspect, realistic solutions to enforce objective inference and improve precision are rare. As a typical randomized trial needs to accommodate many implementation issues beyond statistical considerations, maintaining the objectivity is at least as important as precision gain if not more, particularly from the perspective of the regulatory agencies. In this article, we propose a two-stage estimation procedure based on inverse probability weighting to achieve better precision without compromising objectivity. The procedure is designed in a way such that the covariate adjustment is performed before seeing the outcome, effectively reducing the possibility of selecting a 'favorable' model that yields a strong intervention effect. Both theoretical and numerical properties of the estimation procedure are presented. Application of the proposed method to a real data example is presented. Copyright © 2013 John Wiley & Sons, Ltd.

  17. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

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

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    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 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−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. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  19. Prenatal emotion management improves obstetric outcomes: a randomized control study.

    Science.gov (United States)

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

  20. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study

    NARCIS (Netherlands)

    Witvliet, M.; van Lier, P.A.C.; Cuijpers, P.; Koot, H.M.

    2009-01-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal

  1. Random walk on random walks

    NARCIS (Netherlands)

    Hilário, M.; Hollander, den W.Th.F.; Sidoravicius, V.; Soares dos Santos, R.; Teixeira, A.

    2014-01-01

    In this paper we study a random walk in a one-dimensional dynamic random environment consisting of a collection of independent particles performing simple symmetric random walks in a Poisson equilibrium with density ¿¿(0,8). At each step the random walk performs a nearest-neighbour jump, moving to

  2. 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

  3. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  4. 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.

  5. Benfotiamine in treatment of alcoholic polyneuropathy: an 8-week randomized controlled study (BAP I Study).

    Science.gov (United States)

    Woelk, H; Lehrl, S; Bitsch, R; Köpcke, W

    1998-01-01

    A three-armed, randomized, multicentre, placebo-controlled double-blind study was used to examine the efficacy of benfotiamine vs a combination containing benfotiamine and vitamins B6 and B12 in out-patients with severe symptoms of alcoholic polyneuropathy (Benfotiamine in treatment of Alcoholic Polyneuropathy, BAP I). The study period was 8 weeks and 84 patients fulfilled all the prerequisite criteria and completed the study as planned. Benfotiamine led to significant improvement of alcoholic polyneuropathy. Vibration perception (measured at the tip of the great toe) significantly improved in the course of the study, as did motor function. and the overall score reflecting the entire range of symptoms of alcoholic polyneuropathy. A tendency toward improvement was evident for pain and co-ordination; no therapy-specific adverse effects were seen.

  6. Random Telegraph Signal Amplitudes in Sub 100 nm (Decanano) MOSFETs: A 3D 'Atomistic' Simulation Study

    Science.gov (United States)

    Asenov, Asen; Balasubramaniam, R.; Brown, A. R.; Davies, J. H.; Saini, Subhash

    2000-01-01

    In this paper we use 3D simulations to study the amplitudes of random telegraph signals (RTS) associated with the trapping of a single carrier in interface states in the channel of sub 100 nm (decanano) MOSFETs. Both simulations using continuous doping charge and random discrete dopants in the active region of the MOSFETs are presented. We have studied the dependence of the RTS amplitudes on the position of the trapped charge in the channel and on the device design parameters. We have observed a significant increase in the maximum RTS amplitude when discrete random dopants are employed in the simulations.

  7. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  8. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study

    OpenAIRE

    Ayça Utkan Karasu; Elif Balevi Batur; Gülçin Kaymak Karataş

    2018-01-01

    Objective: To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. Methods: During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Asses...

  9. 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

    an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies. METHODS: We conducted a systematic review...... evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET....

  10. 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.

  11. 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....

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

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... and 14-day quadruple therapies as first-line treatments for Helicobacter pylori infection in ..... Furthermore, in a large-scale, multicenter, Japanese study ... Taylor DE, Ge Z, Purych D, Lo T, Hiratsuka K. Cloning and sequence ...

  13. 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...

  14. Effective permittivity of random composite media: A comparative study

    International Nuclear Information System (INIS)

    Prasad, Ashutosh; Prasad, K.

    2007-01-01

    In the present study, experimental data for effective permittivity of amorphous, polycrystalline thick films, and ceramic form of samples, taken from the literature, have been chosen for their comparison with those yielded by different mixture equations. In order to test the acceptability of dielectric mixture equations for high volume fractions of the inclusion material in the mixture, eleven such equations have been chosen. It is found that equations given by Cuming, Maxwell-Wagner, Webmann, Skipetrov and modified Cule-Torquato show their coherence and minimal deviation from the experimental results of permittivity for all the chosen test materials almost over the entire measurement range of volume fractions. It is further found that Maxwell-Wagner, Webmann, and Skipetrov equations yielded equivalent results and consequently they have been combined together and reckoned as a single equation named MWWS. The study revealed that the Cuming equation had the highest degree of acceptability (errors <±1-5%) in all the cases

  15. Fetal response to abbreviated relaxation techniques. A randomized controlled study.

    Science.gov (United States)

    Fink, Nadine S; Urech, Corinne; Isabel, Fornaro; Meyer, Andrea; Hoesli, Irène; Bitzer, Johannes; Alder, Judith

    2011-02-01

    stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome. this study aims (1) to obtain fetal behavioral states (quiet/active sleep, quiet/active wakefulness), (2) to investigate the effects of maternal relaxation on fetal behavior as well as on uterine activity, and (3) to investigate maternal physiological and endocrine parameters as potential underlying mechanisms for maternal-fetal relaxation-transferral. the behavior of 33 fetuses was analyzed during laboratory relaxation/quiet rest (control group, CG) and controlled for baseline fetal behavior. Potential associations between relaxation/quiet rest and fetal behavior (fetal heart rate (FHR), FHR variation, FHR acceleration, and body movements) and uterine activity were studied, using a computerized cardiotocogram (CTG) system. Maternal heart rate, blood pressure, cortisol, and norepinephrine were measured. intervention (progressive muscle relaxation, PMR, and guided imagery, GI) showed changes in fetal behavior. The intervention groups had higher long-term variation during and after relaxation compared to the CG (p=.039). CG fetuses had more FHR acceleration, especially during and after quiet rest (p=.027). Women in the PMR group had significantly more uterine activity than women in the GI group (p=.011) and than CG women. Maternal heart rate, blood pressure, and stress hormones were not associated with fetal behavior. this study indicates that the fetus might participate in maternal relaxation and suggests that GI is superior to PMR. This could especially be true for women who tend to direct their attention to body sensations such as abdominal activity. 2010 Elsevier Ltd. All rights reserved.

  16. Schoolyard upgrade in a randomized controlled study design

    DEFF Research Database (Denmark)

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

    2017-01-01

    of student perceptions across the intervention schools, and that a one unit increase in the Schoolyard index (SYi) led to a 12% increase in recess PA. This study shows that adolescent PA during recess can be increased through a multicomponent intervention. The prospect for making an impact is low...... and according to the process analysis dependent on direct involvement; active and supportive adults; and varied, connected and well located facilities....

  17. A Randomized Study of a Mobile Behavioral Parent Training Application.

    Science.gov (United States)

    Feil, Edward G; Sprengelmeyer, Peter G; Leve, Craig

    2018-06-01

    Background/Introduction: Never before have parents had such immediate access to parenting support. The extension of the Internet to smartphones, offers the opportunity to provide families with the highest-quality information at the time and place that it can be the most useful. However, there remain considerable barriers to getting the right information to the right people at the right time. This study includes the initial feasibility testing of a smartphone application "ParentNet" that attempts to deliver on the potential of empirically supported therapy by connecting family members with specific behavioral goals and outcomes in real time. Participation was solicited from community parenting support groups and through online social media. Data were collected from 73 parents and 88 children on child behavior (adult only) and satisfaction. Data analyses showed positive satisfaction and utilization results: (1) users rated the ParentNet app very positively (i.e., 85% of caregivers and 88% of youth would recommend the app to others), and (2) parenting behavior was improved with a small/moderate effect-size. Findings from this initial testing are reviewed along with future development possibilities to be considered. Limitations of small pilot sample and brief administration period could have reduced effects. Further study would include a more robust sample.

  18. Effects of psychological therapies in randomized trials and practice-based studies.

    Science.gov (United States)

    Barkham, Michael; Stiles, William B; Connell, Janice; Twigg, Elspeth; Leach, Chris; Lucock, Mike; Mellor-Clark, John; Bower, Peter; King, Michael; Shapiro, David A; Hardy, Gillian E; Greenberg, Leslie; Angus, Lynne

    2008-11-01

    Randomized trials of the effects of psychological therapies seek internal validity via homogeneous samples and standardized treatment protocols. In contrast, practice-based studies aim for clinical realism and external validity via heterogeneous samples of clients treated under routine practice conditions. We compared indices of treatment effects in these two types of studies. Using published transformation formulas, the Beck Depression Inventory (BDI) scores from five randomized trials of depression (N = 477 clients) were transformed into Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) scores and compared with CORE-OM data collected in four practice-based studies (N = 4,196 clients). Conversely, the practice-based studies' CORE-OM scores were transformed into BDI scores and compared with randomized trial data. Randomized trials showed a modest advantage over practice-based studies in amount of pre-post improvement. This difference was compressed or exaggerated depending on the direction of the transformation but averaged about 12%. There was a similarly sized advantage to randomized trials in rates of reliable and clinically significant improvement (RCSI). The largest difference was yielded by comparisons of effect sizes which suggested an advantage more than twice as large, reflecting narrower pre-treatment distributions in the randomized trials. Outcomes of completed treatments for depression in randomized trials appeared to be modestly greater than those in routine care settings. The size of the difference may be distorted depending on the method for calculating degree of change. Transforming BDI scores into CORE-OM scores and vice versa may be a preferable alternative to effect sizes for comparisons of studies using these measures.

  19. 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).

  20. Application of random effects to the study of resource selection by animals.

    Science.gov (United States)

    Gillies, Cameron S; Hebblewhite, Mark; Nielsen, Scott E; Krawchuk, Meg A; Aldridge, Cameron L; Frair, Jacqueline L; Saher, D Joanne; Stevens, Cameron E; Jerde, Christopher L

    2006-07-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence. 2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability. 3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed. 4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects. 5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection. 6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  1. 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......, 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 colorectal cancer....

  2. 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

  3. The Effect of Some Estimators of Between-Study Variance on Random

    African Journals Online (AJOL)

    Samson Henry Dogo

    the first step to such objectivity (Schmidt, 1992), allows to combine results from many studies and accurately ... Schmidt, 2000) due to its ability to account for variation in effects across the studies. Random-effects model ... (2015), and each of the estimators differs in terms of their bias and precision in estimation. By definition ...

  4. 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

  5. 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...

  6. 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

  7. 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

  8. Integrating CHWs as part of the team leading diabetes group visits: A randomized controlled feasibility study

    Science.gov (United States)

    The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n=5...

  9. Correction of confounding bias in non-randomized studies by appropriate weighting.

    Science.gov (United States)

    Schmoor, Claudia; Gall, Christine; Stampf, Susanne; Graf, Erika

    2011-03-01

    In non-randomized studies, the assessment of a causal effect of treatment or exposure on outcome is hampered by possible confounding. Applying multiple regression models including the effects of treatment and covariates on outcome is the well-known classical approach to adjust for confounding. In recent years other approaches have been promoted. One of them is based on the propensity score and considers the effect of possible confounders on treatment as a relevant criterion for adjustment. Another proposal is based on using an instrumental variable. Here inference relies on a factor, the instrument, which affects treatment but is thought to be otherwise unrelated to outcome, so that it mimics randomization. Each of these approaches can basically be interpreted as a simple reweighting scheme, designed to address confounding. The procedures will be compared with respect to their fundamental properties, namely, which bias they aim to eliminate, which effect they aim to estimate, and which parameter is modelled. We will expand our overview of methods for analysis of non-randomized studies to methods for analysis of randomized controlled trials and show that analyses of both study types may target different effects and different parameters. The considerations will be illustrated using a breast cancer study with a so-called Comprehensive Cohort Study design, including a randomized controlled trial and a non-randomized study in the same patient population as sub-cohorts. This design offers ideal opportunities to discuss and illustrate the properties of the different approaches. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Music for surgical abortion care study: a randomized controlled pilot study.

    Science.gov (United States)

    Wu, Justine; Chaplin, William; Amico, Jennifer; Butler, Mark; Ojie, Mary Jane; Hennedy, Dina; Clemow, Lynn

    2012-05-01

    The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; pMusic as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain. Copyright © 2012 Elsevier Inc. All rights reserved.

  11. 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

    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...

  12. Random telegraph signal amplitudes in sub 100 nm (decanano) MOSFETs: a 3D `Atomistic' simulation study

    OpenAIRE

    Asenov, A.; Balasubramaniam, R.; Brown, A.R.; Davies, J.H.; Saini, S.

    2000-01-01

    In this paper we use 3D simulations to study the amplitudes of random telegraph signals (RTS) associated with the trapping of a single carrier in interface states in the channel of sub 100 nm (decanano) MOSFETs. Both simulations using continuous doping charge and random discrete dopants in the active region of the MOSFETs are presented. We have studied the dependence of the RTS amplitudes on the position of the trapped charge in the channel and on the device design parameters. We have observe...

  13. Study on Nonlinear Vibration Analysis of Gear System with Random Parameters

    Science.gov (United States)

    Tong, Cao; Liu, Xiaoyuan; Fan, Li

    2018-03-01

    In order to study the dynamic characteristics of gear nonlinear vibration system and the influence of random parameters, firstly, a nonlinear stochastic vibration analysis model of gear 3-DOF is established based on Newton’s Law. And the random response of gear vibration is simulated by stepwise integration method. Secondly, the influence of stochastic parameters such as meshing damping, tooth side gap and excitation frequency on the dynamic response of gear nonlinear system is analyzed by using the stability analysis method such as bifurcation diagram and Lyapunov exponent method. The analysis shows that the stochastic process can not be neglected, which can cause the random bifurcation and chaos of the system response. This study will provide important reference value for vibration engineering designers.

  14. Experimental study of a quantum random-number generator based on two independent lasers

    Science.gov (United States)

    Sun, Shi-Hai; Xu, Feihu

    2017-12-01

    A quantum random-number generator (QRNG) can produce true randomness by utilizing the inherent probabilistic nature of quantum mechanics. Recently, the spontaneous-emission quantum phase noise of the laser has been widely deployed for quantum random-number generation, due to its high rate, its low cost, and the feasibility of chip-scale integration. Here, we perform a comprehensive experimental study of a phase-noise-based QRNG with two independent lasers, each of which operates in either continuous-wave (CW) or pulsed mode. We implement the QRNG by operating the two lasers in three configurations, namely, CW + CW, CW + pulsed, and pulsed + pulsed, and demonstrate their trade-offs, strengths, and weaknesses.

  15. Study on the Light Scattering from Random Rough Surfaces by Kirrhoff Approximation

    Directory of Open Access Journals (Sweden)

    Keding Yan

    2014-07-01

    Full Text Available In order to study the space distribution characteristics of light scattering from random rough surfaces, the linear filtering method is used to generate a series of Gaussian randomly rough surfaces, and the Kirchhoff Approximation is used to calculate the scattered light intensity distribution from random metal and dielectric rough surfaces. The three characteristics of the scattered light intensity distribution peak, the intensity distribution width and the position of peak are reviewed. Numerical calculation results show that significant differences between scattering characteristics of metal surfaces and the dielectric surfaces exist. The light scattering characteristics are jointly influenced by the slope distribution and reflectance of surface element. The scattered light intensity distribution is affected by common influence of surface local slope distribution and surface local reflectivity. The results can provide a basis theory for the research to lidar target surface scattering characteristics.

  16. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins

    NARCIS (Netherlands)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J.

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions).

  17. 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)

  18. Measurement Error Correction Formula for Cluster-Level Group Differences in Cluster Randomized and Observational Studies

    Science.gov (United States)

    Cho, Sun-Joo; Preacher, Kristopher J.

    2016-01-01

    Multilevel modeling (MLM) is frequently used to detect cluster-level group differences in cluster randomized trial and observational studies. Group differences on the outcomes (posttest scores) are detected by controlling for the covariate (pretest scores) as a proxy variable for unobserved factors that predict future attributes. The pretest and…

  19. 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

  20. A Mendelian Randomization Study of Circulating Uric Acid and Type 2 Diabetes

    NARCIS (Netherlands)

    Sluijs, Ivonne; Holmes, Michael V.; van der Schouw, Yvonne T.; Beulens, Joline W J; Asselbergs, Folkert W.; Huerta, José María; Palmer, Tom M.; Arriola, Larraitz; Balkau, Beverley; Barricarte, Aurelio; Boeing, Heiner; Clavel-Chapelon, Françoise; Fagherazzi, Guy; Franks, Paul W.; Gavrila, Diana; Kaaks, Rudolf; Khaw, Kay T ee; Kühn, Tilman; Molina-Montes, Esther; Mortensen, Lotte M axild; Nilsson, Peter M.; Overvad, Kim; Palli, Domenico; Panico, Salvatore; Quirós, J. Ramón; Rolandsson, Olov; Sacerdote, Carlotta; Sala, Núria; Schmidt, Julie A.; Scott, Robert A.; Sieri, Sabina; Slimani, Nadia; Spijkerman, Annemieke M W; Tjonneland, Anne; Travis, Ruth C.; Tumino, Rosario; van der A, Daphne L.; Sharp, Stephen J.; Forouhi, Nita G.; Langenberg, Claudia; Riboli, Elio; Wareham, Nicholas J.

    2015-01-01

    We aimed to investigate the causal effect of circulating uric acid concentrations on type 2 diabetes risk. A Mendelian randomization study was performed using a genetic score with 24 uric acid-associated loci. We used data of the European Prospective Investigation into Cancer and Nutrition

  1. A Randomized Control Study of Responsive Teaching with Young Turkish Children and Their Mothers

    Science.gov (United States)

    Karaaslan, Ozcan; Diken, Ibrahim H.; Mahoney, Gerald

    2013-01-01

    A randomized control study was conducted to evaluate the effectiveness of responsive teaching (RT) with a sample of 19 Turkish preschool-age children with disabilities and their mothers over a 6-months period. RT is an early intervention curriculum that attempts to promote children's development by encouraging parents to engage in highly…

  2. Mirtazapine in generalized social anxiety disorder: a randomized, double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Schutters, Sara I. J.; van Megen, Harold J. G. M.; van Veen, Jantien Frederieke; Denys, Damiaan A. J. P.; Westenberg, Herman G. M.

    2010-01-01

    This study is aimed at investigating the efficacy and tolerability of mirtazapine in a generalized social anxiety disorder. Sixty patients with generalized social anxiety disorder were randomly allocated to receive mirtazapine (30-45 mg/day) (n = 30) or placebo (n = 30) for 12 weeks in a

  3. Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

    Science.gov (United States)

    This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

  4. 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

    OBJECTIVE: To compare the rate of obstetric interventions, length of labor, and maternal morbidity in pregnancies with prelabor rupture of membranes at term after either early or late induction of labor in both primiparous and pluriparous women. DESIGN: Prospective, randomized study. SUBJECTS: 362...... primiparous and pluriparous (p rupture of membranes to delivery increased...

  5. Histeroscopia cirúrgica com ressectoscópio para polipectomia endometrial: eficácia e segurança Operative hysteroscopy with resectoscope for endometrial polypectomy: efficacy and safety

    Directory of Open Access Journals (Sweden)

    Hélio de Lima Ferreira Fernandes Costa

    2001-07-01

    Full Text Available Objetivos: avaliar os resultados das primeiras 104 polipectomias histeroscópicas em nossa instituição de ensino. Métodos: estudo retrospectivo descritivo. Foram revistos os registros das primeiras 136 histeroscopias cirúrgicas realizadas no serviço, sendo 104 polipectomias. Foram avaliadas características das pacientes operadas como idade, paridade, fase da vida reprodutiva e sintomatologia; número e tamanho dos pólipos e os resultados em relação às complicações e remissão dos sintomas. Resultados: as pacientes tinham em média 52,7 anos, sendo três quartos delas multíparas. Encontravam-se na pós-menopausa 60 pacientes (57,7% do grupo. Cerca de metade das pacientes apresentavam sintomas atribuíveis aos pólipos, sendo o sangramento anormal o mais comum (47,1%. Em 16,3% dos casos havia mais de um pólipo, sendo que 84% deles mediam mais de 1 cm. A única complicação imediata de importância foi uma perfuração uterina, sendo que as complicações tardias foram raras e sem gravidade. O tempo médio de seguimento foi de 9 meses. Em 82% das pacientes houve remissão das queixas. Apenas 8,2% das pacientes necessitaram de histerectomia complementar, todas com outras doenças uterinas, como mioma, adenomiose ou hiperplasia endometrial atípica, a qual foi encontrada em apenas 1 paciente. Conclusões: a polipectomia histeroscópica mostrou-se método simples, seguro e eficaz no tratamento dos pólipos endometriais. A seleção das pacientes deve ser rigorosa para evitar procedimentos cirúrgicos complementares.Purpose: to evaluate the results of the first 104 hysteroscopic polypectomies in a teaching hospital. Methods: a retrospective descriptive study was designed. Medical records of the first 136 operative hysteroscopies - 104 of which polypectomies - were reviewed. Patient characteristics such as age, parity, period of reproductive function and symptoms; number and size of polyps and results concerning complications and symptom

  6. 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.

  7. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages

    Science.gov (United States)

    Kim, Yoonsang; Emery, Sherry

    2013-01-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods’ performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages—SAS GLIMMIX Laplace and SuperMix Gaussian quadrature—perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes. PMID:24288415

  8. Monte Carlo studies of two-dimensional random-anisotropy magnets

    Science.gov (United States)

    Denholm, D. R.; Sluckin, T. J.

    1993-07-01

    We have carried out a systematic set of Monte Carlo simulations of the Harris-Plischke-Zuckermann lattice model of random magnetic anisotropy on a two-dimensional square lattice, using the classical Metropolis algorithm. We have considered varying temperature T, external magnetic field H (both in the reproducible and irreproducible limits), time scale of the simulation τ in Monte Carlo steps and anisotropy ratio D/J. In the absence of randomness this model reduces to the XY model in two dimensions, which possesses the familiar Kosterlitz-Thouless low-temperature phase with algebraic but no long-range order. In the presence of random anisotropy we find evidence of a low-temperature phase with some disordered features, which might be identified with a spin-glass phase. The low-temperature Kosterlitz-Thouless phase survives at intermediate temperatures for low randomness, but is no longer present for large D/J. We have also studied the high-H approach to perfect order, for which there are theoretical predictions due to Chudnovsky.

  9. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages.

    Science.gov (United States)

    Kim, Yoonsang; Choi, Young-Ku; Emery, Sherry

    2013-08-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods' performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages-SAS GLIMMIX Laplace and SuperMix Gaussian quadrature-perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes.

  10. Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.

    Science.gov (United States)

    DeZern, Amy E; Williams, Katherine; Zahurak, Marianna; Hand, Wesley; Stephens, R Scott; King, Karen E; Frank, Steven M; Ness, Paul M

    2016-07-01

    Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused. Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms. This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting. © 2016 AABB.

  11. 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 .

  12. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  13. 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

  14. Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

    Science.gov (United States)

    Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

    2002-05-01

    Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

  15. Linear Regression with a Randomly Censored Covariate: Application to an Alzheimer's Study.

    Science.gov (United States)

    Atem, Folefac D; Qian, Jing; Maye, Jacqueline E; Johnson, Keith A; Betensky, Rebecca A

    2017-01-01

    The association between maternal age of onset of dementia and amyloid deposition (measured by in vivo positron emission tomography (PET) imaging) in cognitively normal older offspring is of interest. In a regression model for amyloid, special methods are required due to the random right censoring of the covariate of maternal age of onset of dementia. Prior literature has proposed methods to address the problem of censoring due to assay limit of detection, but not random censoring. We propose imputation methods and a survival regression method that do not require parametric assumptions about the distribution of the censored covariate. Existing imputation methods address missing covariates, but not right censored covariates. In simulation studies, we compare these methods to the simple, but inefficient complete case analysis, and to thresholding approaches. We apply the methods to the Alzheimer's study.

  16. 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...

  17. Genome Wide Association Study to predict severe asthma exacerbations in children using random forests classifiers

    Directory of Open Access Journals (Sweden)

    Litonjua Augusto A

    2011-06-01

    Full Text Available Abstract Background Personalized health-care promises tailored health-care solutions to individual patients based on their genetic background and/or environmental exposure history. To date, disease prediction has been based on a few environmental factors and/or single nucleotide polymorphisms (SNPs, while complex diseases are usually affected by many genetic and environmental factors with each factor contributing a small portion to the outcome. We hypothesized that the use of random forests classifiers to select SNPs would result in an improved predictive model of asthma exacerbations. We tested this hypothesis in a population of childhood asthmatics. Methods In this study, using emergency room visits or hospitalizations as the definition of a severe asthma exacerbation, we first identified a list of top Genome Wide Association Study (GWAS SNPs ranked by Random Forests (RF importance score for the CAMP (Childhood Asthma Management Program population of 127 exacerbation cases and 290 non-exacerbation controls. We predict severe asthma exacerbations using the top 10 to 320 SNPs together with age, sex, pre-bronchodilator FEV1 percentage predicted, and treatment group. Results Testing in an independent set of the CAMP population shows that severe asthma exacerbations can be predicted with an Area Under the Curve (AUC = 0.66 with 160-320 SNPs in comparison to an AUC score of 0.57 with 10 SNPs. Using the clinical traits alone yielded AUC score of 0.54, suggesting the phenotype is affected by genetic as well as environmental factors. Conclusions Our study shows that a random forests algorithm can effectively extract and use the information contained in a small number of samples. Random forests, and other machine learning tools, can be used with GWAS studies to integrate large numbers of predictors simultaneously.

  18. Effects of functional restoration versus 3 hours per week physical therapy: a randomized controlled study.

    Science.gov (United States)

    Jousset, Nathalie; Fanello, Serge; Bontoux, Luc; Dubus, Valérie; Billabert, Colette; Vielle, Bruno; Roquelaure, Yves; Penneau-Fontbonne, Dominique; Richard, Isabelle

    2004-03-01

    Randomized parallel-group comparative trial with a 6-month follow-up period. To compare, in chronic low back pain patients, the effectiveness of a functional restoration program, including intensive physical training, occupational therapy, and psychological support to an active individual therapy consisting of 3 hours physical therapy per week during 5 weeks. Controlled studies conducted in the United States showed a benefit of functional restoration in patients with low back pain, especially on return to work. Randomized Canadian and European trials had less favorable results. In France, there has been up to now no randomized study. Controlled studies suggested a positive effect of functional restoration programs. Eighty-six patients with low back pain were randomized to either the functional restoration (44 patients) or the active individual therapy (42 patients) program. One person in each group never started the program. Two patients did not complete the functional restoration program, and one was lost to follow-up at 6 months. The mean number of sick-leave days in the 2 previous years was 6 months. After adjustment on the variable "workplace enrolled in an ergonomic program", the mean number of sick-leave days was significantly lower in the functional restoration group. Physical criteria and treatment appreciation were also better. There was no significant difference in the intensity of pain, the quality of life and functional indexes, the psychological characteristics, the number of contacts with the medical system, and the drug intake. This study demonstrates the effectiveness of a functional restoration program on important outcome measures, such as sick leave, in a country that has a social system that protects people facing difficulties at work.

  19. The Effectiveness of School-Based Nutritional Education Program among Obese Adolescents: A Randomized Controlled Study

    OpenAIRE

    In-Iw, Supinya; Saetae, Tridsanun; Manaboriboon, Boonying

    2012-01-01

    The purpose of the study was to determine the change in body weight and body mass index (BMI), as well as diet behaviors at 4 months after intervention between obese adolescent girls who participated in the school-based nutritional education program, addressed by pediatrician, compared to those who attended regular nutritional class. Methods. 49 obese girls were recruited from a secondary school. Those, were randomized into 2 groups of intervention and control. The intensive interactive nutri...

  20. Case management: a randomized controlled study comparing a neighborhood team and a centralized individual model.

    OpenAIRE

    Eggert, G M; Zimmer, J G; Hall, W J; Friedman, B

    1991-01-01

    This randomized controlled study compared two types of case management for skilled nursing level patients living at home: the centralized individual model and the neighborhood team model. The team model differed from the individual model in that team case managers performed client assessments, care planning, some direct services, and reassessments; they also had much smaller caseloads and were assigned a specific catchment area. While patients in both groups incurred very high estimated healt...

  1. Reducing procrastination using a smartphone-based treatment program: A randomized controlled pilot study

    OpenAIRE

    Christian Aljoscha Lukas; Matthias Berking

    2018-01-01

    Background: Procrastination affects a large number of individuals and is associated with significant mental health problems. Despite the deleterious consequences individuals afflicted with procrastination have to bear, there is a surprising paucity of well-researched treatments for procrastination. To fill this gap, this study evaluated the efficacy of an easy-to-use smartphone-based treatment for procrastination. Method: N=31 individuals with heightened procrastination scores were randomly a...

  2. Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

    2014-11-20

    Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of

  3. Randomized study: small cell anaplastic lung cancer treated by combination chemotherapy and adjuvant radiotherapy

    International Nuclear Information System (INIS)

    Fox, R.M.; Woods, R.L.; Brodie, G.N.; Tattersall, M.H.N.

    1980-01-01

    Chemotherapy and primary site radiation therapy were compared to chemotherapy alone in a randomized study of 125 patients with small cell cancer of the lung. The sites of initial relapse, as well as disease free and overall survival were analyzed. Radiotherapy to the primary site reduced the rate of local relapse, but median survival was not prolonged in patients with either limited or extensive disease, when the radiation therapy-chemotherapy group was compared to the group that received chemotherapy alone

  4. 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

    2017-11-01

    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 < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  5. A practical introduction to Random Forest for genetic association studies in ecology and evolution.

    Science.gov (United States)

    Brieuc, Marine S O; Waters, Charles D; Drinan, Daniel P; Naish, Kerry A

    2018-03-05

    Large genomic studies are becoming increasingly common with advances in sequencing technology, and our ability to understand how genomic variation influences phenotypic variation between individuals has never been greater. The exploration of such relationships first requires the identification of associations between molecular markers and phenotypes. Here, we explore the use of Random Forest (RF), a powerful machine-learning algorithm, in genomic studies to discern loci underlying both discrete and quantitative traits, particularly when studying wild or nonmodel organisms. RF is becoming increasingly used in ecological and population genetics because, unlike traditional methods, it can efficiently analyse thousands of loci simultaneously and account for nonadditive interactions. However, understanding both the power and limitations of Random Forest is important for its proper implementation and the interpretation of results. We therefore provide a practical introduction to the algorithm and its use for identifying associations between molecular markers and phenotypes, discussing such topics as data limitations, algorithm initiation and optimization, as well as interpretation. We also provide short R tutorials as examples, with the aim of providing a guide to the implementation of the algorithm. Topics discussed here are intended to serve as an entry point for molecular ecologists interested in employing Random Forest to identify trait associations in genomic data sets. © 2018 John Wiley & Sons Ltd.

  6. Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

    2016-09-29

    Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www

  7. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study

    DEFF Research Database (Denmark)

    Laursen, Stig Borbjerg; Hansen, Jane Møller; Andersen, Poul Erik

    2014-01-01

    OBJECTIVE: One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients...... with high-risk ulcers. MATERIAL AND METHODS: The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE...... of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality. RESULTS: Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwent successful STAE. There was no difference...

  8. 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...

  9. A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study.

    Science.gov (United States)

    Newman, William G; Payne, Katherine; Tricker, Karen; Roberts, Stephen A; Fargher, Emily; Pushpakom, Sudeep; Alder, Jane E; Sidgwick, Gary P; Payne, Debbie; Elliott, Rachel A; Heise, Marco; Elles, Robert; Ramsden, Simon C; Andrews, Julie; Houston, J Brian; Qasim, Faeiza; Shaffer, Jon; Griffiths, Christopher E M; Ray, David W; Bruce, Ian; Ollier, William E R

    2011-06-01

    To conduct a pragmatic, randomized controlled trial to assess whether thiopurine methyltransferase (TPMT) genotyping prior to azathioprine reduces adverse drug reactions (ADRs). A total of 333 participants were randomized 1:1 to undergo TPMT genotyping prior to azathioprine or to commence treatment without genotyping. There was no difference in the primary outcome of stopping azathioprine due to an adverse reaction (ADR, p = 0.59) between the two study arms. ADRs were more common in older patients (p = 0.01). There was no increase in stopping azathioprine due to ADRs in TPMT heterozygotes compared with wild-type individuals. The single individual with TPMT variant homozygosity experienced severe neutropenia. Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine.

  10. Study of Landau spectrum for a two-dimensional random magnetic field

    International Nuclear Information System (INIS)

    Furtlehner, C.

    1997-01-01

    This thesis deals with the two-dimensional problem of a charged particle coupled to a random magnetic field. Various situations are considered, according to the relative importance of the mean value of field and random component. The last one is conceived as a distribution of magnetic impurities (punctual vortex), having various statistical properties (local or non-local correlations, Poisson distribution, etc). The study of this system has led to two distinct situations: - the case of the charged particle feeling the influence of mean field that manifests its presence in the spectrum of broadened Landau levels; - the disordered situation in which the spectrum can be distinguished from the free one only by a low energy Lifshits behaviour. Additional properties are occurring in the limit of 'strong' mean field, namely a non-conventional low energy behaviour (in contrast to Lifshits behaviour) which was interpreted in terms of localized states. (author)

  11. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

    2017-04-08

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

  12. Using Behavioral Analytics to Increase Exercise: A Randomized N-of-1 Study.

    Science.gov (United States)

    Yoon, Sunmoo; Schwartz, Joseph E; Burg, Matthew M; Kronish, Ian M; Alcantara, Carmela; Julian, Jacob; Parsons, Faith; Davidson, Karina W; Diaz, Keith M

    2018-04-01

    This intervention study used mobile technologies to investigate whether those randomized to receive a personalized "activity fingerprint" (i.e., a one-time tailored message about personal predictors of exercise developed from 6 months of observational data) increased their physical activity levels relative to those not receiving the fingerprint. A 12-month randomized intervention study. From 2014 to 2015, 79 intermittent exercisers had their daily physical activity assessed by accelerometry (Fitbit Flex) and daily stress experience, a potential predictor of exercise behavior, was assessed by smartphone. Data collected during the first 6 months of observation were used to develop a person-specific "activity fingerprint" (i.e., N-of-1) that was subsequently sent via email on a single occasion to randomized participants. Pre-post changes in the percentage of days exercised were analyzed within and between control and intervention groups. The control group significantly decreased their proportion of days exercised (10.5% decrease, purban adults. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  13. Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

    2014-06-01

    The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

  14. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  15. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  16. A randomized study of a method for optimizing adolescent assent to biomedical research.

    Science.gov (United States)

    Annett, Robert D; Brody, Janet L; Scherer, David G; Turner, Charles W; Dalen, Jeanne; Raissy, Hengameh

    2017-01-01

    Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

  17. 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

  18. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

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

    Directory of Open Access Journals (Sweden)

    J C Censin

    2017-08-01

    Full Text Available 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 (<17 years T1D were extracted from a meta-analysis of genome-wide association study with 5,913 T1D cases and 8,828 reference samples. Using inverse-variance weighted 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

  20. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  1. Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

    Science.gov (United States)

    Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

    2016-01-01

    Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

  2. Study of RNA structures with a connection to random matrix theory

    International Nuclear Information System (INIS)

    Bhadola, Pradeep; Deo, Nivedita

    2015-01-01

    This manuscript investigates the level of complexity and thermodynamic properties of the real RNA structures and compares the properties with the random RNA sequences. A discussion on the similarities of thermodynamical properties of the real structures with the non linear random matrix model of RNA folding is presented. The structural information contained in the PDB file is exploited to get the base pairing information. The complexity of an RNA structure is defined by a topological quantity called genus which is calculated from the base pairing information. Thermodynamic analysis of the real structures is done numerically. The real structures have a minimum free energy which is very small compared to the randomly generated sequences of the same length. This analysis suggests that there are specific patterns in the structures which are preserved during the evolution of the sequences and certain sequences are discarded by the evolutionary process. Further analyzing the sequences of a fixed length reveal that the RNA structures exist in ensembles i.e. although all the sequences in the ensemble have different series of nucleotides (sequence) they fold into structures that have the same pairs of hydrogen bonding as well as the same minimum free energy. The specific heat of the RNA molecule is numerically estimated at different lengths. The specific heat curve with temperature shows a bump and for some RNA, a double peak behavior is observed. The same behavior is seen in the study of the random matrix model with non linear interaction of RNA folding. The bump in the non linear matrix model can be controlled by the change in the interaction strength.

  3. Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

    Science.gov (United States)

    Keren, Ron; Carpenter, Myra A.; Hoberman, Alejandro; Shaikh, Nader; Matoo, Tej K.; Chesney, Russell W.; Matthews, Ranjiv; Gerson, Arlene C.; Greenfield, Saul P.; Fivush, Barbara; McLurie, Gordon A.; Rushton, H. Gil; Canning, Douglas; Nelson, Caleb P.; Greenbaum, Lawrence; Bukowski, Timothy; Primack, William; Sutherland, Richard; Hosking, James; Stewart, Dawn; Elder, Jack; Moxey-Mims, Marva; Nyberg, Leroy

    2010-01-01

    OBJECTIVE Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae. PMID:19018048

  4. Study of Randomness in AES Ciphertexts Produced by Randomly Generated S-Boxes and S-Boxes with Various Modulus and Additive Constant Polynomials

    Science.gov (United States)

    Das, Suman; Sadique Uz Zaman, J. K. M.; Ghosh, Ranjan

    2016-06-01

    In Advanced Encryption Standard (AES), the standard S-Box is conventionally generated by using a particular irreducible polynomial {11B} in GF(28) as the modulus and a particular additive constant polynomial {63} in GF(2), though it can be generated by many other polynomials. In this paper, it has been shown that it is possible to generate secured AES S-Boxes by using some other selected modulus and additive polynomials and also can be generated randomly, using a PRNG like BBS. A comparative study has been made on the randomness of corresponding AES ciphertexts generated, using these S-Boxes, by the NIST Test Suite coded for this paper. It has been found that besides using the standard one, other moduli and additive constants are also able to generate equally or better random ciphertexts; the same is true for random S-Boxes also. As these new types of S-Boxes are user-defined, hence unknown, they are able to prevent linear and differential cryptanalysis. Moreover, they act as additional key-inputs to AES, thus increasing the key-space.

  5. 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

  6. Vitamin D and C-Reactive Protein: A Mendelian Randomization Study.

    Directory of Open Access Journals (Sweden)

    Marte C Liefaard

    Full Text Available Vitamin D deficiency is widely prevalent and has been associated with many diseases. It has been suggested that vitamin D has effects on the immune system and inhibits inflammation. The aim of our study was to investigate whether vitamin D has an inhibitory effect on systemic inflammation by assessing the association between serum levels of vitamin D and C-reactive protein. We studied the association between serum 25-hydroxyvitamin D and C-reactive protein through linear regression in 9,649 participants of the Rotterdam Study, an observational, prospective population-based cohort study. We used genetic variants related to vitamin D and CRP to compute a genetic risk score and perform bi-directional Mendelian randomization analysis. In linear regression adjusted for age, sex, cohort and other confounders, natural log-transformed CRP decreased with 0.06 (95% CI: -0.08, -0.03 unit per standard deviation increase in 25-hydroxyvitamin D. Bi-directional Mendelian randomization analyses showed no association between the vitamin D genetic risk score and lnCRP (Beta per SD = -0.018; p = 0.082 or the CRP genetic risk score and 25-hydroxyvitamin D (Beta per SD = 0.001; p = 0.998. In conclusion, higher levels of Vitamin D are associated with lower levels of C-reactive protein. In this study we did not find evidence for this to be the result of a causal relationship.

  7. Manual and Electroacupuncture for Labour Pain: Study Design of a Longitudinal Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Linda Vixner

    2012-01-01

    Full Text Available Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

  8. The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

    Science.gov (United States)

    Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

    2013-11-01

    In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

  9. Effect of tranexamic acid on gross hematuria: A pilot randomized clinical trial study.

    Science.gov (United States)

    Moharamzadeh, Payman; Ojaghihaghighi, Seyedhossein; Amjadi, Mohsen; Rahmani, Farzad; Farjamnia, Arezoo

    2017-12-01

    Local forms of the tranexamic acid have been effective in treating many haemorrhagic cases. So that the aim of the current study is to assess the effectiveness of local tranexamic acid in controlling painless hematuria in patients referred to the emergency department. This is a randomized, double-blind clinical trial study, which was conducted on 50 patients with complaints of painless lower urinary tract bleeding during June 2014 and August 2015. The patients were randomly divided into two groups of 25 people each, one group receiving tranexamic acid and the other given a placebo. During bladder irrigation, local tranexamic acid and the placebo were injected into the bladder via Foley catheter. Patients were examined over 24h in terms of the amount of normal saline serum used for irrigation, level of hemoglobin, and blood in urine. In this study it was observed that consumption of tranexamic acid significantly decreased the volume of used serum for bladder irrigation (P=0.041) and the microscopic status of urine decreased significantly in terms of the hematuria after 24h (P=0.026). However, the rate of packed cell transfusion and drop in hemoglobin levels showed no significant difference in both groups of patients (P˃0.05). The results of this study showed that tranexamic acid could significantly reduce the volume of required serum for bladder irrigation to clear urine, but it had no significant effect on the drop in serum hemoglobin levels. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. 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.

  11. 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.

  12. Timing of food intake impacts daily rhythms of human salivary microbiota: a randomized, crossover study.

    Science.gov (United States)

    Collado, María Carmen; Engen, Phillip A; Bandín, Cristina; Cabrera-Rubio, Raúl; Voigt, Robin M; Green, Stefan J; Naqib, Ankur; Keshavarzian, Ali; Scheer, Frank A J L; Garaulet, Marta

    2018-04-01

    The composition of the diet (what we eat) has been widely related to the microbiota profile. However, whether the timing of food consumption (when we eat) influences microbiota in humans is unknown. A randomized, crossover study was performed in 10 healthy normal-weight young women to test the effect of the timing of food intake on the human microbiota in the saliva and fecal samples. More specifically, to determine whether eating late alters daily rhythms of human salivary microbiota, we interrogated salivary microbiota in samples obtained at 4 specific time points over 24 h, to achieve a better understanding of the relationship between food timing and metabolic alterations in humans. Results revealed significant diurnal rhythms in salivary diversity and bacterial relative abundance ( i.e., TM7 and Fusobacteria) across both early and late eating conditions. More importantly, meal timing affected diurnal rhythms in diversity of salivary microbiota toward an inverted rhythm between the eating conditions, and eating late increased the number of putative proinflammatory taxa, showing a diurnal rhythm in the saliva. In a randomized, crossover study, we showed for the first time the impact of the timing of food intake on human salivary microbiota. Eating the main meal late inverts the daily rhythm of salivary microbiota diversity which may have a deleterious effect on the metabolism of the host.-Collado, M. C., Engen, P. A., Bandín, C., Cabrera-Rubio, R., Voigt, R. M., Green, S. J., Naqib, A., Keshavarzian, A., Scheer, F. A. J. L., Garaulet, M. Timing of food intake impacts daily rhythms of human salivary microbiota: a randomized, crossover study.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Finite temperature simulation studies of spin-flop magnetic random access memory devices

    International Nuclear Information System (INIS)

    Chui, S.T.; Chang, C.-R.

    2006-01-01

    Spin-flop structures are currently being developed for magnetic random access memory devices. We report simulation studies of this system. We found the switching involves an intermediate edge-pinned domain state, similar to that observed in the single layer case. This switching scenario is quite different from that based on the coherent rotation picture. A significant temperature dependence of the switching field is observed. Our result suggests that the interplane coupling and thus the switching field has to be above a finite threshold for the spin-flop switching to be better than conventional switching methods

  18. 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.

  19. On the random cascading model study of anomalous scaling in multiparticle production with continuously diminishing scale

    International Nuclear Information System (INIS)

    Liu Lianshou; Zhang Yang; Wu Yuanfang

    1996-01-01

    The anomalous scaling of factorial moments with continuously diminishing scale is studied using a random cascading model. It is shown that the model currently used have the property of anomalous scaling only for descrete values of elementary cell size. A revised model is proposed which can give good scaling property also for continuously varying scale. It turns out that the strip integral has good scaling property provided the integral regions are chosen correctly, and that this property is insensitive to the concrete way of self-similar subdivision of phase space in the models. (orig.)

  20. 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

  1. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Narita, Zui; Yokoi, Yuma

    2017-06-19

    Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

  2. 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.

  3. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study

    Directory of Open Access Journals (Sweden)

    Ayça Utkan Karasu

    2018-03-01

    Full Text Available Objective: To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. Methods: During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12 or the control group (n = 11 by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Assessment Scale for Stroke Patients, Timed Up and Go Test and Static Balance Index. Secondary outcome measures were postural sway, as assessed with Emed-X, Functional Independence Measure Transfer and Ambulation Scores. An evaluator who was blinded to the groups made assessments immediately before (baseline, immediately after (post-treatment, and 4 weeks after completion of the study (follow-up. Results: Group-time interaction was significant in the Berg Balance Scale, Functional Reach Test, anteroposterior and mediolateral centre of pressure displacement with eyes open, anteroposterior centre of pressure displacement with eyes closed, centre of pressure displacement during weight shifting to affected side, to unaffected side and total centre of pressure displacement during weight shifting. Demonstrating significant group-time interaction in those parameters suggests that, while both groups exhibited significant improvement, the experimental group showed greater improvement than the control group. Conclusion: Virtual reality exercises with the Nintendo Wii system could represent a useful adjunctive therapy to traditional treatment to improve static and dynamic balance in stroke patients.

  4. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study.

    Science.gov (United States)

    Karasu, Ayça Utkan; Batur, Elif Balevi; Karataş, Gülçin Kaymak

    2018-05-08

    To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Assessment Scale for Stroke Patients, Timed Up and Go Test and Static Balance Index. Secondary outcome measures were postural sway, as assessed with Emed-X, Functional Independence Measure Transfer and Ambulation Scores. An evaluator who was blinded to the groups made assessments immediately before (baseline), immediately after (post-treatment), and 4 weeks after completion of the study (follow-up). Group-time interaction was significant in the Berg Balance Scale, Functional Reach Test, anteroposterior and mediolateral centre of pressure displacement with eyes open, anteroposterior centre of pressure displacement with eyes closed, centre of pressure displacement during weight shifting to affected side, to unaffected side and total centre of pressure displacement during weight shifting. Demonstrating significant group-time interaction in those parameters suggests that, while both groups exhibited significant improvement, the experimental group showed greater improvement than the control group. Virtual reality exercises with the Nintendo Wii system could represent a useful adjunctive therapy to traditional treatment to improve static and dynamic balance in stroke patients.

  5. Bird's nest versus the Kimray-Greenfield inferior vena cava filter: Randomized clinical study

    International Nuclear Information System (INIS)

    Athanasoulis, C.A.; Roberts, A.C.; Brown, K.; Geller, S.C.; Waltman, A.C.; Eckstein, M.R.

    1987-01-01

    A randomized clinical study was conducted comparing the percutaneously introduced bird's nest inferior vena cava (IVC) filter and the Kimray-Greenfield IVC filter. Study end points included recurrent pulmonary embolism, new or worse leg venous stasis symptoms, IVC thrombosis, and ease of filter introduction. Of the 109 patients in the study, 58 were randomly assigned to the BN and 51 to the KG filter. Demographic factors were comparable between the two groups. Follow-up entailed cavography, noninvasive assessment of the femoral veins, and standardized telephone interviews. The follow-up period was extended to 1 year after filter insertion. Results for the bird's nest versus the Kimray-Greenfield filter respectively were as follows: death due to massive pulmonary embolism, 3% versus 5%; recurrent pulmonary embolism, 1.5% versus 7.5%; filter migration, 1.1% versus 0.0%; IVC thrombosis, 6% versus 2.5%; new or worse leg edema, 28.5% versus 22%; ease of introduction (qualitative), maximal versus minimal; patient discomfort (qualitative), minimal versus maximal. The authors conclude the bird's nest filter is better than the Kimray-Greenfield filter in terms of prevention of recurrent pulmonary embolism and ease of introduction. In terms of venous stasis, the bird's nest filter is not better and may be worse than the Kimray-Greenfield filter. Filter migration is a problem with the bird's nest filter

  6. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

  7. 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.

  8. 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.

  9. Reliability Study of Energy Harvesting from Sea Waves by Piezoelectric Patches Consideraing Random JONSWAP Wave Theory

    Directory of Open Access Journals (Sweden)

    M. Ettefagh

    2018-03-01

    Full Text Available One of the new methods for powering low-power electronic devices employed in the sea, is using of mechanical energies of sea waves. In this method, piezoelectric material is employed to convert the mechanical energy of sea waves into electrical energy. The advantage of this method is based on not implementing the battery charging system. Although, many studies have been done about energy harvesting from sea waves, energy harvesting with considering random JONWSAP wave theory is not fully studied up to now. The random JONSWAP wave model is a more realistic approximation of sea waves in comparison of Airy wave model. Therefore, in this paper a vertical beam with the piezoelectric patches, which is fixed to the seabed, is considered as energy harvester system. The energy harvesting system is simulated by MATLAB software, and then the vibration response of the beam and consequently the generated power is obtained considering the JONWSAP wave theory. In addition, the reliability of the system and the effect of piezoelectric patches uncertainties on the generated power are studied by statistical method. Furthermore, the failure possibility of harvester based on violation criteria is investigated.  

  10. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

    2014-06-21

    Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

  11. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study.

    Science.gov (United States)

    Laursen, Stig Borbjerg; Hansen, Jane Møller; Andersen, Poul Erik; Schaffalitzky de Muckadell, Ove B

    2014-01-01

    One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers. The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE of the bleeding artery within 24 h or continued standard treatment. Randomization was stratified according to stigmata of hemorrhage. Patients were followed for 30 days. Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement, development of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality. Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwent successful STAE. There was no difference in composite endpoint. Two versus eight patients re-bled in the STAE and control group, respectively (Intention-to-treat analysis; p = .10). After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding (p = .079). STAE is potentially useful for preventing rebleeding in high-risk PUB. STAE can safely be performed in selected cases with high risk of rebleeding. Further studies are needed in order to confirm these findings; ClincialTrials.gov number, NCT01125852.

  12. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

    2016-11-16

    The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

  13. 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.

  14. Coordinate based random effect size meta-analysis of neuroimaging studies.

    Science.gov (United States)

    Tench, C R; Tanasescu, Radu; Constantinescu, C S; Auer, D P; Cottam, W J

    2017-06-01

    Low power in neuroimaging studies can make them difficult to interpret, and Coordinate based meta-analysis (CBMA) may go some way to mitigating this issue. CBMA has been used in many analyses to detect where published functional MRI or voxel-based morphometry studies testing similar hypotheses report significant summary results (coordinates) consistently. Only the reported coordinates and possibly t statistics are analysed, and statistical significance of clusters is determined by coordinate density. Here a method of performing coordinate based random effect size meta-analysis and meta-regression is introduced. The algorithm (ClusterZ) analyses both coordinates and reported t statistic or Z score, standardised by the number of subjects. Statistical significance is determined not by coordinate density, but by a random effects meta-analyses of reported effects performed cluster-wise using standard statistical methods and taking account of censoring inherent in the published summary results. Type 1 error control is achieved using the false cluster discovery rate (FCDR), which is based on the false discovery rate. This controls both the family wise error rate under the null hypothesis that coordinates are randomly drawn from a standard stereotaxic space, and the proportion of significant clusters that are expected under the null. Such control is necessary to avoid propagating and even amplifying the very issues motivating the meta-analysis in the first place. ClusterZ is demonstrated on both numerically simulated data and on real data from reports of grey matter loss in multiple sclerosis (MS) and syndromes suggestive of MS, and of painful stimulus in healthy controls. The software implementation is available to download and use freely. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

    Science.gov (United States)

    Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

    2014-03-01

    Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  16. Renal effects of dexmedetomidine during coronary artery bypass surgery: a randomized placebo-controlled study

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    Scheinin Harry

    2011-05-01

    Full Text Available Abstract Background Dexmedetomidine, an alpha2-adrenoceptor agonist, has been evaluated as an adjunct to anesthesia and for the delivery of sedation and perioperative hemodynamic stability. It provokes dose-dependent and centrally-mediated sympatholysis. Coronary artery bypass grafting (CABG with extracorporeal circulation is a stressful procedure increasing sympathetic nervous system activity which could attenuate renal function due the interrelation of sympathetic nervous system, hemodynamics and renal function. We tested the hypothesis that dexmetomidine would improve kidney function in patients undergoing elective CABG during the first two postoperative days. Methods This was a double-blind, randomized, parallel-group study. Patients with normal renal function and scheduled for elective CABG were randomized to placebo or to infusion of dexmedetomidine to achieve a pseudo steady-state plasma concentration of 0.60 ng/ml. The infusion was started after anesthesia induction and continued until 4 h after surgery. The primary endpoint was creatinine clearance. Other variables included urinary creatinine and output, fractional sodium and potassium excretion, urinary potassium, sodium and glucose, serum and urinary osmolality and plasma catecholamine concentrations. The data were analyzed with repeated-measures ANOVA or Cochran-Mantel-Haenszel test. Results Sixty-six of 87 randomized patients were evaluable for analysis. No significant between-group differences were recorded for any indices of renal function except for a mean 74% increase in urinary output with dexmedetomidine in the first 4 h after insertion of a urinary catheter (p Conclusions Use of intravenous dexmedetomidine did not alter renal function in this cohort of relatively low-risk elective CABG patients but was associated with an increase in urinary output. This study was carried out in 1994-1997 and was thus not registered.

  17. 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 < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our 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.

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

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    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

  19. Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

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    Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

    2017-02-01

    Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

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

    Science.gov (United States)

    Lash, Timothy L

    2007-11-26

    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. 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. 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. Bias analysis provides a more complete picture of true uncertainty than conventional frequentist statistical analysis accompanied by a qualitative description of study limitations. The latter approach is

  1. 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

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

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    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

  3. Preoperative warm-up the key to improved resident technique: a randomized study.

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    Moran-Atkin, Erin; Abdalla, Gamal; Chen, Grace; Magnuson, Thomas H; Lidor, Anne O; Schweitzer, Michael A; Steele, Kimberley E

    2015-05-01

    The ACGME has required that a skills lab be incorporated into the surgical residency curriculum. While the value of warm-up is generally accepted in other areas requiring complex motor skills, there is little evidence to support the benefits of warm-up prior to performing surgery. We are conducting this study in an attempt to identify whether a warm-up period prior to operating impacts operative technique. All general surgery residents and MIS fellows were included in this IRB-approved randomized study. Participants were randomized to either warm-up or no warm-up groups. Participants randomized to the warm-up group completed a 10 min practice session in the simulation lab within 1 h of starting the case, using an FLS training box. At the conclusion of the operation, the participant was evaluated by the attending surgeon using the validated global rating scales of Reznick and Vassiliou. The attending surgeons were blinded to the use of pre-procedure warm-up. The results of the questionnaire were analyzed using student's t test with p warm-up (19) or no warm-up (21). There was a statistically significant improvement in depth perception (p = 0.02), bimanual dexterity (p = 0.01), and efficiency of movements (p = 0.03) for those randomized to warm-up. There was statistical improvement when we preformed a composite scoring of the attending evaluations for each of the Reznick (p = 0.008) and the Vassiliou (p = 0.01) global rating scales. Preoperative warm-up significantly improves depth perception, bimanual dexterity, and efficiency of movements, as well as improvement in composite scores as judged by the attending surgeon. The lack of self-perceived improvement by the residents may be a reflection of the high standards and intense self-critique that is common among surgical trainees. We believe that our findings, while preliminary, reflect that surgical performance can be enhanced through structured warm-up activities.

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

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    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.

  5. Effect of flashlight guidance on manual ventilation performance in cardiopulmonary resuscitation: A randomized controlled simulation study.

    Science.gov (United States)

    Kim, Ji Hoon; Beom, Jin Ho; You, Je Sung; Cho, Junho; Min, In Kyung; Chung, Hyun Soo

    2018-01-01

    Several auditory-based feedback devices have been developed to improve the quality of ventilation performance during cardiopulmonary resuscitation (CPR), but their effectiveness has not been proven in actual CPR situations. In the present study, we investigated the effectiveness of visual flashlight guidance in maintaining high-quality ventilation performance. We conducted a simulation-based, randomized, parallel trial including 121 senior medical students. All participants were randomized to perform ventilation during 2 minutes of CPR with or without flashlight guidance. For each participant, we measured mean ventilation rate as a primary outcome and ventilation volume, inspiration velocity, and ventilation interval as secondary outcomes using a computerized device system. Mean ventilation rate did not significantly differ between flashlight guidance and control groups (P = 0.159), but participants in the flashlight guidance group exhibited significantly less variation in ventilation rate than participants in the control group (Pguidance group. Our results demonstrate that flashlight guidance is effective in maintaining a constant ventilation rate and interval. If confirmed by further studies in clinical practice, flashlight guidance could be expected to improve the quality of ventilation performed during CPR.

  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 life satisfaction, mood, and sleep quality at most observation times (P fibromyalgia and to enhance the quality of life in affected individuals. © 2016 World Institute of Pain.

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

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    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.

  8. Randomized clinical trials as reflexive-interpretative process in patients with rheumatoid arthritis: a qualitative study.

    Science.gov (United States)

    de Jorge, Mercedes; Parra, Sonia; de la Torre-Aboki, Jenny; Herrero-Beaumont, Gabriel

    2015-08-01

    Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category "Interactional Empowerment" emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: "weight of systematisation", "working together", and the significance of the experience: "the duties". Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive-interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved.

  9. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    Science.gov (United States)

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  10. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Science.gov (United States)

    Fiorentino, Lavinia; McQuaid, John R; Liu, Lianqi; Natarajan, Loki; He, Feng; Cornejo, Monique; Lawton, Susan; Parker, Barbara A; Sadler, Georgia R; Ancoli-Israel, Sonia

    2010-01-01

    Purpose 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. PMID:23616695

  11. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    Science.gov (United States)

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Results Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted. PMID:24773615

  12. Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

    Science.gov (United States)

    Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

    2012-02-01

    The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

  13. 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.

  14. 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.

  15. The effectiveness of Narrative Exposure Therapy with traumatised firefighters in Saudi Arabia: a randomized controlled study.

    Science.gov (United States)

    Alghamdi, Mohammed; Hunt, Nigel; Thomas, Shirley

    2015-03-01

    Firefighters are exposed to many traumatic events. The psychological costs of this exposure increase the risk of Post-Traumatic Stress disorder (PTSD), depression and anxiety. This study examined the effectiveness of Narrative Exposure Therapy (NET) as a short-term treatment for reducing PTSD symptoms among Saudi firefighters. A randomized waiting-list control study was conducted with 34 traumatized firefighters were randomly allocated to NET or Waiting-list Control (WLC). The NET group received four therapy sessions of 60-90 min over a three-week period; those in the WLC condition received the same sessions after a three-week waiting period. Participants in both groups were assessed at baseline, immediately post-intervention and at 3 and 6 month follow ups. NET led to significant reductions in PTSD symptoms, anxiety and depression compared with WLC. After the WLC group received treatment, it showed the same improvements as the NET group. This occurred immediately post-treatment in both groups, but was not sustained at 3 and 6 month follow ups. Coping strategies and social support led to significant changes only in follow up times. NET was effective in reducing PTSD symptoms in traumatised Saudi firefighters. This finding could be helpful in the management of PTSD among people who work as first responders such as firefighters, police officers and emergency medical personal, as well as security officers. Copyright © 2015. Published by Elsevier Ltd.

  16. 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 ( P <0.05). There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary 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.

  17. 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.

  18. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study.

    Science.gov (United States)

    Kim, Eunjung; Cain, Kevin C; Webster-Stratton, Carolyn

    2008-09-01

    Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.

  19. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study.

    Science.gov (United States)

    Akhtari, Elham; Raisi, Firoozeh; Keshavarz, Mansoor; Hosseini, Hamed; Sohrabvand, Farnaz; Bioos, Soodabeh; Kamalinejad, Mohammad; Ghobadi, Ali

    2014-04-28

    Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted.

  20. 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.

  1. Wheeled mobility skills of wheelchair basketball players: a randomized controlled study.

    Science.gov (United States)

    Saltan, Asuman; Bakar, Yeşim; Ankarali, Handan

    2017-05-01

    The aim of this study was to assess the influence of wheelchair basketball sport on the functional abilities of wheelchair users. This is a randomized controlled study. Wheelchair basketball players (n = 111) and non-player (n = 85) were included in this study. We administered the questionnaire version of the wheelchair skills test questionnaire (WST_Q), recording the participants' capacity and performance scores on each of 32 skills. Player group have the baseline values of WST_Q higher than control group. The mean total percentage score of player group was significantly greater than control group (p skills-sports relationship is reciprocal. With increased wheelchair skills, people may be more inclined to engage in sports; subsequently, with greater sports, wheelchair skills could improve. Wheelchair mobility skills during clinical rehabilitation should reflect the daily activities and needs of each wheelchair user. WST-Q provides advantages in terms of requiring less time and material in using of clinical.

  2. The effect of a peer education program on combating violence against women: A randomized controlled study.

    Science.gov (United States)

    Gürkan, Özlem C; Kömürcü, Nuran

    2017-10-01

    Student nurses in Turkey need to be exposed to appropriate undergraduate training if they are to acquire the required knowledge, attitudes and skills that will help them to fight the issue of violence against women (VAW). The aim of this research study was to assess the effect of a peer education program about combating VAW on the knowledge, attitudes and skills of nursing students. The study was designed as a randomized controlled trial. The participants in the intervention group received peer education on combating VAW. 136 nursing students (intervention group: n=63, control group: n=73) were included in the study. Participants in both the intervention and control groups were assessed at pre-training and at two months post-training. Pre-training and post-training knowledge and attitudes were significantly different in the intervention group (peducation should be used as a part of undergraduate nursing education on VAW. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  4. Apixaban for treatment of embolic stroke of undetermined source (ATTICUS randomized trial): Rationale and study design.

    Science.gov (United States)

    Geisler, Tobias; Poli, Sven; Meisner, Christoph; Schreieck, Juergen; Zuern, Christine S; Nägele, Thomas; Brachmann, Johannes; Jung, Werner; Gahn, Georg; Schmid, Elisabeth; Bäezner, Hansjörg; Keller, Timea; Petzold, Gabor C; Schrickel, Jan-Wilko; Liman, Jan; Wachter, Rolf; Schön, Frauke; Schabet, Martin; Lindner, Alfred; Ludolph, Albert C; Kimmig, Hubert; Jander, Sebastian; Schlegel, Uwe; Gawaz, Meinrad; Ziemann, Ulf

    2017-12-01

    Rationale Optimal secondary prevention of embolic stroke of undetermined source is not established. The current standard in these patients is acetylsalicylic acid, despite high prevalence of yet undetected paroxysmal atrial fibrillation. Aim The ATTICUS randomized trial is designed to determine whether the factor Xa inhibitor apixaban administered within 7 days after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of new ischemic lesions documented by brain magnetic resonance imaging within 12 months after index stroke. Design Prospective, randomized, blinded, parallel-group, open-label, German multicenter phase III trial in approximately 500 patients with embolic stroke of undetermined source. A key inclusion criterion is the presence or the planned implantation of an insertable cardiac monitor. Patients are 1:1 randomized to apixaban or acetylsalicylic acid and treated for a 12-month period. It is an event-driven trial aiming for core-lab adjudicated primary outcome events. Study outcomes The primary outcome is the occurrence of at least one new ischemic lesion identified by axial T2-weighted FLAIR magnetic resonance imaging and/or axial DWI magnetic resonance imaging at 12 months when compared with the baseline magnetic resonance imaging. Key secondary outcomes are the combination of recurrent ischemic strokes, hemorrhagic strokes, systemic embolism; combination of MACE including recurrent stroke, myocardial infarction, and cardiovascular death and combination of major and clinically relevant non-major bleeding defined according to ISTH, and change of cognitive function and quality of life (EQ-5D, Stroke Impact Scale). Discussion Embolic stroke of undetermined source is caused by embolic disease and associated with a high risk of recurrent ischemic strokes and clinically silent cerebral ischemic lesions. ATTICUS will investigate the impact of atrial fibrillation detected by insertable cardiac monitor and the effects of

  5. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    Science.gov (United States)

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

  6. A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru

    Science.gov (United States)

    Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

    2017-01-01

    Abstract Objective To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. Methods A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru’s national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Findings Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1–4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0–2.6). These improvements were equitable, being independent of household poverty. Conclusion A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project. PMID:28479622

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

    Science.gov (United States)

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

    2012-01-01

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

  8. 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...

  9. Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

    2016-06-02

    The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. Intraarticular glucocorticoid, morphine and bupivacaine reduces pain and convalescence after arthroscopic ankle surgery: a randomized study of 36 patients

    DEFF Research Database (Denmark)

    Rasmussen, S; Kehlet, H

    2000-01-01

    In a double-blind randomized study, 36 patients undergoing arthroscopic removal of bony spurs and synovitis causing impingement of the ankle were allocated to intraarticular saline or bupivacaine 15 mg + morphine 5 mg + intraarticular methylprednisolone 40 mg. Combined methylprednisolone, bupivac......In a double-blind randomized study, 36 patients undergoing arthroscopic removal of bony spurs and synovitis causing impingement of the ankle were allocated to intraarticular saline or bupivacaine 15 mg + morphine 5 mg + intraarticular methylprednisolone 40 mg. Combined methylprednisolone...

  17. Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

    Science.gov (United States)

    Poon, R. T.; Chow, L. W.

    1998-01-01

    A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory. PMID:9635849

  18. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study

    Science.gov (United States)

    Drumond Marra, Hellen Livia; Myczkowski, Martin Luiz; Maia Memória, Cláudia; Arnaut, Débora; Leite Ribeiro, Philip; Sardinha Mansur, Carlos Gustavo; Lancelote Alberto, Rodrigo; Boura Bellini, Bianca; Alves Fernandes da Silva, Adriano; Ciampi de Andrade, Daniel; Teixeira, Manoel Jacobsen; Forlenza, Orestes Vicente; Marcolin, Marco Antonio

    2015-01-01

    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. PMID:26160997

  19. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study.

    Science.gov (United States)

    Witvliet, Miranda; van Lier, Pol A C; Cuijpers, Pim; Koot, Hans M

    2009-10-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal classroom-based preventive intervention, or a control condition. Children's acceptance by peers, their number of mutual friends, and their proximity to others were assessed annually through peer ratings. Externalizing behavior was annually rated by teachers. Reductions in children's externalizing behavior and improvements in positive peer relations were found among GBG children, as compared with control-group children. Reductions in externalizing behavior appeared to be partly mediated by the improvements in peer acceptance. This mediating role of peer acceptance was found for boys only. The results suggest that positive peer relations are not just markers, but they are environmental mediators of boys' externalizing behavior development. Implications for research and prevention are discussed. (c) 2009 APA, all rights reserved.

  20. A Randomized Clinical Trial of Auricular Point Acupressure for Chronic Low Back Pain: A Feasibility Study

    Directory of Open Access Journals (Sweden)

    Chao Hsing Yeh

    2013-01-01

    Full Text Available Objectives. This prospective, randomized clinical trial (RCT was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA for chronic low back pain (CLBP. Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP. The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment. Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group (P<0.01 at the completion of a 4-week APA and 1 month followup. Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

  1. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study.

    Science.gov (United States)

    Wang, Man; Tong, Jian-hua; Zhu, Gang; Liang, Guang-ming; Yan, Hong-fei; Wang, Xiu-zhen

    2012-06-01

    To evaluate the efficacy of metformin for treatment of antipsychotic-induced weight gain. Seventy-two patients with first-episode schizophrenia who gained more than 7% of their predrug weight were randomly assigned to receive 1000 mg/d of metformin or placebo in addition to their ongoing treatment for 12 weeks using a double-blind study design. The primary outcome was change in body weight. The secondary outcomes included changes in body mass index, fasting glucose and insulin, and insulin resistance index. Of the 72 patients who were randomly assigned, 66 (91.6%) completed treatments. The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period. Significantly more patients in the metformin group lost their baseline weight by more than 7%, which was the cutoff for clinically meaningful weight loss. Metformin was tolerated well by majority patients. Metformin was effective and safe in attenuating antipsychotic-induced weight gain and insulin resistance in first-episode schizophrenia patients. Patients displayed good adherence to metformin. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Efficacy of sucralfate in the postoperative management of uvulopalatopharyngoplasty: a double-blind, randomized, controlled study.

    Science.gov (United States)

    Zodpe, Prakash; Cho, Jae Gu; Kang, Hee Joon; Hwang, Soon Jae; Lee, Heung-Man

    2006-10-01

    To evaluate the effectiveness of sucralfate in influencing throat pain, otalgia, analgesic requirement, bleeding, mucosal recovery, and incidence of postoperative bleeding in patients undergoing uvulopalatopharyngoplasty. A prospective double-blind randomized study. University-affiliated tertiary referral hospital. Eighty adult patients with obstructive sleep apnea syndrome requiring uvulopalatopharyngoplasty were recruited and randomly allocated into either a sucralfate treatment group or a control group. All patients underwent uvulopalatopharyngoplasty. Patients enrolled in the sucralfate group (n=40) were instructed to gargle the sucralfate suspension and then to swallow. Patients enrolled in the control group (n=40) were instructed to gargle placebo suspension at the same doses and schedule. Postoperative throat pain, otalgia, amount of analgesic required, degree of strength (defined as patients' general well-being and return to regular daily activities), percentage of mucosal covering, and postoperative bleeding. Throat pain and otalgia occurred significantly less often in sucralfate group, with less analgesic requirement and with rapid mucosal healing and early return to regular daily activities. There was no significant difference in episodes of postoperative bleeding between the 2 groups (P=.37). Although sucralfate therapy may not provide complete analgesia after uvulopalatopharyngoplasty, it may reduce the amount of analgesic required, thus preventing dose-related adverse effects from the analgesic agent. It can also significantly reduce the total number of days needed to return to normal daily activities (P=.41).

  3. 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.

  4. Bilirubin as a potential causal factor in type 2 diabetes risk: a Mendelian randomization study

    Science.gov (United States)

    Abbasi, Ali; Deetman, Petronella E.; Corpeleijn, Eva; Gansevoort, Ron T.; Gans, Rijk O.B.; Hillege, Hans L.; van der Harst, Pim; Stolk, Ronald P.; Navis, Gerjan; Alizadeh, Behrooz Z.; Bakker, Stephan J.L.

    2014-01-01

    Circulating bilirubin, a natural antioxidant, is associated with decreased risk of type 2 diabetes (T2D), but the nature of the relationship remains unknown. We performed Mendelian randomization in a prospective cohort of 3,381 participants free of diabetes at baseline (aged 28-75 years; women, 52.6%). We used rs6742078 located in UDP-glucuronosyltransferase (UGT1A1) locus as instrumental variable (IV) to study a potential causal effect of serum total bilirubin on T2D risk. T2D developed in a total of 210 (6.2%) participants during a median follow-up of 7.8 years. In adjusted analyses, rs6742078, which explained 19.5% of bilirubin variation, was strongly associated with total bilirubin (a 0.68-SD increase in bilirubin levels per T allele; Pbilirubin levels, we observed a 25% (OR 0.75 [95%CI, 0.62-0.92]; P=0.004) lower risk of T2D. In Mendelian randomization analysis, the causal risk reduction for T2D was estimated to be 42% (causal ORIVestimation per 1-SD increase in log-transformed bilirubin 0.58 [95%CI, 0.39-0.84]; P=0.005), which was comparable to the observational estimate (Durbin-Wu-Hausman chi-square test Pfor difference =0.19). These novel results provide evidence that elevated bilirubin is causally associated with risk of T2D and support its role as a protective determinant. PMID:25368098

  5. Ulcerative colitis patients with an inflammatory response upon mesalazine cannot be desensitized: a randomized study.

    Science.gov (United States)

    Buurman, Dorien J; De Monchy, Jan G R; Schellekens, Reinout C A; van der Waaij, Laurens A; Kleibeuker, Jan H; Dijkstra, Gerard

    2015-04-01

    Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fever and gastrointestinal symptoms. Several case reports reported successful desensitization of patients with mesalazine intolerance. The aim was to assess the number of UC patients who are persistently intolerant to mesalazine after single-blinded rechallenge and to test the effectiveness of a rapid desensitization protocol in UC patients demonstrated mesalazine intolerance. This is a prospective, single-blind randomized study in UC patients who discontinued mesalazine because of intolerance. Patients with severe reactions were excluded. Eligible patients underwent a skin patch test with mesalazine followed by a single-blinded randomized crossover rechallenge with 500 mg mesalazine or placebo. Patients with symptoms upon rechallenge were admitted to the hospital for 3 days oral desensitization. Nine of the 37 identified UC patients who discontinued mesalazine because of intolerance were included. All nine patients had negative patch tests, seven patients had symptoms (fever, nausea, vomiting and diarrhea) within 2 h upon rechallenge. Four of these seven patients participated in the desensitization protocol and in none a successful desensitization could be performed. All four had an inflammatory intolerance reaction with rise in C-reactive protein. There were no elevations in serum tryptase or urinary-methylhistamine levels observed and no signs of immediate type allergic reactions, like urticaria, bronchial obstruction or anaphylaxis. We recommend not to rechallenge UC patients with an inflammatory response upon mesalazine and these patients will not benefit from a rapid desensitization protocol.

  6. Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study

    Science.gov (United States)

    Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

    2016-01-01

    Objectives. To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods. A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results. The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion. Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

  7. Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

    Science.gov (United States)

    Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

    2012-01-01

    This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

  8. Topical tocopherol for treatment of reticular oral lichen planus: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Bacci, C; Vanzo, V; Frigo, A C; Stellini, E; Sbricoli, L; Valente, M

    2017-01-01

    This randomized, double-blind, placebo-controlled crossover study assessed the efficacy of topical tocopherol acetate compared with placebo in easing oral discomfort in patients with reticular oral lichen planus (ROLP). Thirty-four patients with clinically diagnosed and histologically confirmed ROLP were randomly assigned to two groups, which received first one of two treatments (treatment 1 or 2) for a month, then the other (treatment 2 or 1) for another month, with a two-week washout between them. One treatment contained tocopherol acetate and the other only liquid paraffin. The primary outcome was less discomfort, measured on a visual analog scale (VAS). Secondary outcomes were as follows: length of striae measured and photographed at each follow-up; surface area of lesions; and a modified Thongprasom score. No statistically significant differences emerged between the two treatments (1 vs 2) in terms of VAS scores (P > 0.05; 0.8624) or length of striae (P = 0.0883). Significant differences were seen for surface area of lesions (P < 0.05, P = 0.0045) and modified Thongprasom scores (P = 0.0052). The two treatments differed only in terms of the surface area of the lesions and Thongprasom scores, not in VAS scores for discomfort or the length of patients' striae. Topical tocopherol proved effective in the treatment of ROLP. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Liberal Versus Restrictive Fluid Management in Knee Arthroplasty: A Randomized, Double-Blind Study

    DEFF Research Database (Denmark)

    Holte, Kathrine; Kristensen, Billy Bjarne; Valentiner, Lotte

    2007-01-01

    BACKGROUND: There are few data describing the relationship between amount of perioperative fluid and organ function. In this study we investigated the effects of two levels of intravascular fluid administration ("liberal" versus "restrictive") in knee arthroplasty on physiological recovery...... with a standardized volume of colloid. All other aspects of perioperative management (including anesthesia, preoperative fluid status, and postoperative management) were standardized. Primary outcome variables included pulmonary function (spirometry), exercise capacity ("timed up and go" test), coagulation...... as the primary outcome variable. METHODS: In a double-blind study, 48 ASA I-III patients undergoing fast-track elective knee arthroplasty were randomized to restrictive or liberal perioperative intravascular fluid administration. Patients received a fixed rate infusion of Ringer's lactate solution...

  10. Cost effectiveness of preventive home visits to the elderly: economic evaluation alongside randomized controlled study

    DEFF Research Database (Denmark)

    Kronborg, Christian; Vass, Mikkel; Lauridsen, Jørgen

    2006-01-01

    We evaluated the cost effectiveness of preventive home visits to elderly persons in Denmark alongside a 3-year randomized controlled study. The main outcome measure was incremental costs per active life-year gained. The number of active life-years was defined as those during which the person...... is able independently to transfer, walk indoors, go outdoors, walk outdoors in both pleasant and poor weather, and climb stairs. In 17 of 34 municipalities health visitors and general practitioners were offered geriatric training, which focused on early signs of disability, physical activity......,455 to 744) in 75-year-olds and 694 euro (-2,684 to 4,071) in 80-year-olds. The discounted difference in mean active life-years was 0.034 (-0.058 to 0.125) and 0.197 (0.013 to 0.380), respectively. The study did not provide conclusive evidence on the cost effectiveness of the programs under consideration....

  11. Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

    Science.gov (United States)

    Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

    2014-05-01

    To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

  12. 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

    2018-08-01

    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

  13. Random matrices and random difference equations

    International Nuclear Information System (INIS)

    Uppuluri, V.R.R.

    1975-01-01

    Mathematical models leading to products of random matrices and random difference equations are discussed. A one-compartment model with random behavior is introduced, and it is shown how the average concentration in the discrete time model converges to the exponential function. This is of relevance to understanding how radioactivity gets trapped in bone structure in blood--bone systems. The ideas are then generalized to two-compartment models and mammillary systems, where products of random matrices appear in a natural way. The appearance of products of random matrices in applications in demography and control theory is considered. Then random sequences motivated from the following problems are studied: constant pulsing and random decay models, random pulsing and constant decay models, and random pulsing and random decay models

  14. A RANDOMIZED CONTROLLED PLACEBO STUDY OF DEXTROSE IONTOPHORESIS VERSUS DEXTROSE PROLOTHERAPY IN CASE OF KNEE OSTEOARTHRITIS

    Directory of Open Access Journals (Sweden)

    Mahmoud Mohamed Ahmed Ewidea

    2015-12-01

    Full Text Available Background: Osteoarthritis is the most common cause of musculoskeletal pain and disability in the knee joint. This study investigated the efficacy of Dextrose iontophoresis versus Dextrose prolotherapy in case of knee osteoarthritis in a randomized, placebo-controlled, double-blinded study. Methods: sixty patients diagnosed mild to moderate osteoarthritis were included in the study. Their age's were45:65 years with mean age 51 ± 3.5 years. Patients were divided randomly into three equal groups, group (Areceived 50 % dextrose iontophoresis, group (B Each patient received three intra-articular injections of dextrose at 1-month intervals in weeks 0, 4, and 8 and group (C received sham iontophoresis. The outcome measurements were Western Ontario and McMaster Universities arthritis index (WOMAC values, knee ROM, and pain severity at rest (seated and in activity (after walking 6 m using the visual analogue scale (VAS were recorded. The patients were evaluated for these parameters before allocated in their groups then after 4, 8, and 24 weeks later. Results: compared to sham group (placebo there were significant improvement of VAS and ROM of iontophoresis group than sham (placebo group (p<0.000. Also there were significant improvement of prolotherapy group than placebo (p<0.006, and 0.02 respectively. Furthermore there was significant improve of iontophoresis group than prolotherapy where p was <0.000 for VAS, ROM and (WOMAC. Conclusion: The results of this study suggested that both dextrose iontophoresis and dextrose prolotherapy may be as useful modalities in treatment of osteoarthritis with better effects of dextrose iontophoresis than prolotherapy.

  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

    Directory of Open Access Journals (Sweden)

    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. On-Demand Treatment of Premature Ejaculation with Citalopram: A Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Ghafuri Zahra

    2009-10-01

    Full Text Available "nAs the most common male sexual disorder premature ejaculation (PE, also referred to as early ejaculation (EE or rapid ejaculation (RE, affects 30%-40% of sexually active men. Despite the limited number of available studies comparing the efficacy of selective serotonin re-uptake inhibitors (SSRI they have been thought to have beneficial effects for the treatment of patients with PE. In the present study, we assessed the efficacy of on-demand use of citalopram, in the treatment of premature ejaculation. A randomized double blind study of fixed dose on-demand use of citalopram was performed in Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample was consisted of 80 married patients diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders. The patients were randomly assigned to two groups: group 1 consisting of 42 patients received 20mg citalopram, and group 2 consisting of 38 patients received placebo four hours before intercourse for a 4-week treatment course. The effects of drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of treatment course. The mean IELT increased from 66.78±36.94 to 80.85±43.05 seconds in group 1 and from 63.44±33.16 to 65.71±34.26 seconds in group 2 (P = 0.000. Mean CIPE score increased 1.14±1.04 and 0.52±0.50 in group 1 and 2 respectively (P = 0.002. The patients treated with on demand citalopram showed significantly greater improvement in IELT and CIPE score compared to the patients receiving placebo. It seems that citalopram may be an effective treatment of premature ejaculation with on-demand usage. However further studies are warranted.

  18. Pion radiation for high grade astrocytoma: results of a randomized study

    International Nuclear Information System (INIS)

    Pickles, Tom; Goodman, George B.; Rheaume, Dorianne E.; Duncan, Graeme G.; Fryer, Chris J.; Bhimji, Shamim; Ludgate, Charles; Syndikus, Isabel; Graham, Peter; Dimitrov, Mario; Bowen, Julie

    1997-01-01

    Purpose: This study attempted to compare within a randomized study the outcome of pion radiation therapy vs. conventional photon irradiation for the treatment of high-grade astrocytomas. Methods and Materials: Eighty-four patients were randomized to pion therapy (33-34.5 Gyπ), or conventional photon irradiation (60 Gy). Entry criteria included astrocytoma (modified Kernohan high Grade 3 or Grade 4), age 18-70, Karnofsky performance status (KPS) ≥50, ability to start irradiation within 30 days of surgery, unifocal tumor, and treatment volume < 850 cc. The high-dose volume in both arms was computed tomography enhancement plus a 2-cm margin. The study was designed with the power to detect a twofold difference between arms. Results: Eighty-one eligible patients were equally balanced for all known prognostic variables. Pion patients started radiation 7 days earlier on average than photon patients, but other treatment-related variables did not differ. There were no significant differences for either early or late radiation toxicity between treatment arms. Actuarial survival analysis shows no differences in terms of time to local recurrence or overall survival where median survival was 10 months in both arms (p = 0.22). The physician-assessed KPS and patient-assessed quality of life (QOL) measurements were generally maintained within 10 percentage points until shortly before tumor recurrence. There was no apparent difference in the serial KPS or QOL scores between treatment arms. Conclusion: In contrast to high linear energy transfer (LET) therapy for central nervous system tumors, such as neutron or neon therapy, the safety of pion therapy, which is of intermediate LET, has been reaffirmed. However, this study has demonstrated no therapeutic gain for pion therapy of glioblastoma

  19. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder.

    Science.gov (United States)

    Sayed, Sehrish; Van Dam, Nicholas T; Horn, Sarah R; Kautz, Marin M; Parides, Michael; Costi, Sara; Collins, Katherine A; Iacoviello, Brian; Iosifescu, Dan V; Mathé, Aleksander A; Southwick, Steven M; Feder, Adriana; Charney, Dennis S; Murrough, James W

    2018-01-01

    Anxiety and trauma-related disorders are among the most prevalent and disabling medical conditions in the United States, and posttraumatic stress disorder in particular exacts a tremendous public health toll. We examined the tolerability and anxiolytic efficacy of neuropeptide Y administered via an intranasal route in patients with posttraumatic stress disorder. Twenty-six individuals were randomized in a cross-over, single ascending dose study into 1 of 5 cohorts: 1.4 mg (n=3), 2.8 mg (n=6), 4.6 mg (n=5), 6.8 mg (n=6), and 9.6 mg (n=6). Each individual was dosed with neuropeptide Y or placebo on separate treatment days 1 week apart in random order under double-blind conditions. Assessments were conducted at baseline and following a trauma script symptom provocation procedure subsequent to dosing. Occurrence of adverse events represented the primary tolerability outcome. The difference between treatment conditions on anxiety as measured by the Beck Anxiety Inventory and the State-Trait Anxiety Inventory immediately following the trauma script represented efficacy outcomes. Twenty-four individuals completed both treatment days. Neuropeptide Y was well tolerated up to and including the highest dose. There was a significant interaction between treatment and dose; higher doses of neuropeptide Y were associated with a greater treatment effect, favoring neuropeptide Y over placebo on Beck Anxiety Inventory score (F1,20=4.95, P=.038). There was no significant interaction for State-Trait Anxiety Inventory score. Our study suggests that a single dose of neuropeptide Y is well tolerated up to 9.6 mg and may be associated with anxiolytic effects. Future studies exploring the safety and efficacy of neuropeptide Y in stress-related disorders are warranted. The reported study is registered at: http://clinicaltrials.gov (ID: NCT01533519). © The Author(s) 2017. Published by Oxford University Press on behalf of CINP.

  20. Dilator Use After Vaginal Brachytherapy for Endometrial Cancer: A Randomized Feasibility and Adherence Study.

    Science.gov (United States)

    Hanlon, Alexandra; Small, William; Strauss, Jonathan; Lin, Lilie L; Hanisch, Laura; Huang, Liming; Bai, Jinbing; Wells, Jessica; Bruner, Deborah Watkins

    Vaginal brachytherapy, a common treatment of endometrial cancer, is associated with high rates of vaginal stenosis. Recommendations for vaginal dilator use to minimize stenosis generally include 3 times per week for approximately 10 minutes per use. However, adherence rates range widely and are generally well less than 50%. The aims of this study were to assess feasibility of recruitment to a study of dilator use and test a theoretically driven enhanced educational program (EEP) to increase adherence. Eligibility included women treated with postoperative vaginal brachytherapy for stage I to IIIc endometrial cancer. Patients were randomized to either nurse-delivered standard institutional instruction or EEP. Of eligible patients, 76% consented, 42 were randomized, and 69% completed the 6-month assessment. Mean age was 58.2 years; 48% were sexually active. There was no difference in adherence between arms. Overall, 20% and 8.3% were adherent to the prescribed use of 3 times per week, and 64% and 16% were adherent to use at least once per week at 6 weeks and 6 months, respectively. Adherence was greater among those motivated by vaginal health and having lower body mass index. Nonadherence was significantly higher among those who are college educated, in the EEP group, and with higher weight. Feasibility of recruitment into a study of vaginal dilator use was high. Adherence was low, and there was no difference between groups. Adherence to vaginal dilator use requires novel interventions to test. Nursing education that includes how dilators may maintain vaginal health may improve use because it was a motivator for adherence in this study.

  1. Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Sungha; Kim, Jae Kyoun; Son, Mi Ju; Kim, Dongwoung; Song, Bongkeun; Son, Ilhong; Kang, Hyung Won; Lee, Jongdeok; Kim, Sungchul

    2018-04-13

    Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2-3 months. Previous studies have found a neuro-protective and anti-neuroinflammatory effect of Mecasin, with retrospective studies providing suggestive evidence for a beneficial effect of Mecasin. The aim of this study was to develop a protocol to determine the proper dosage of Mecasin. This is a phase II-A, multi-center, randomized study with three arms. Thirty-six patients with ALS will be randomly assigned to one of three groups, each receiving the standard treatment with 100 mg of riluzole in addition to one of 1.6 g of Mecasin, 2.4 g of Mecasin, or a placebo. The Primary outcome is the Korean version of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised result after 12 weeks of treatment. Secondary outcomes include results of the Short Form Health Survey-8, Medical Research Council Scale, Visual Analogue Scale for Pain, Hamilton Rating Scale for Depression, Fatigue Severity Scale, Patient Global Impression of Change, pulmonary function test, forced expiratory volume in 1 s and its ratio to forced vital capacity, creatine kinase, and body weight. The frequencies of total adverse events and serious adverse events will be described and documented. The trial protocol has been approved by the Institutional Review Board of the Wonkwang University Gwangju and Sanbon Hospital (2016-5-4 and 2016-34-01, respectively). An Investigational New Drug status (30731) was granted by the Korea Food and Drug Administration. This trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS. Korean National Clinical Trial Registry CRIS; KCT

  2. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

    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.

  3. 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.

  4. 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.

  5. Random glucose is useful for individual prediction of type 2 diabetes: results of the Study of Health in Pomerania (SHIP).

    Science.gov (United States)

    Kowall, Bernd; Rathmann, Wolfgang; Giani, Guido; Schipf, Sabine; Baumeister, Sebastian; Wallaschofski, Henri; Nauck, Matthias; Völzke, Henry

    2013-04-01

    Random glucose is widely used in routine clinical practice. We investigated whether this non-standardized glycemic measure is useful for individual diabetes prediction. The Study of Health in Pomerania (SHIP), a population-based cohort study in north-east Germany, included 3107 diabetes-free persons aged 31-81 years at baseline in 1997-2001. 2475 persons participated at 5-year follow-up and gave self-reports of incident diabetes. For the total sample and for subjects aged ≥50 years, statistical properties of prediction models with and without random glucose were compared. A basic model (including age, sex, diabetes of parents, hypertension and waist circumference) and a comprehensive model (additionally including various lifestyle variables and blood parameters, but not HbA1c) performed statistically significantly better after adding random glucose (e.g., the area under the receiver-operating curve (AROC) increased from 0.824 to 0.856 after adding random glucose to the comprehensive model in the total sample). Likewise, adding random glucose to prediction models which included HbA1c led to significant improvements of predictive ability (e.g., for subjects ≥50 years, AROC increased from 0.824 to 0.849 after adding random glucose to the comprehensive model+HbA1c). Random glucose is useful for individual diabetes prediction, and improves prediction models including HbA1c. Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  6. 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

  7. The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

    Science.gov (United States)

    Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

    2016-08-01

    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 ≤30kg/m(2)). 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 and

  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. Elevated serum urate is a potential factor in reduction of total bilirubin: a Mendelian randomization study

    Science.gov (United States)

    Zhang, Hui; Liu, Jing; Dong, Zheng; Ding, Yue; Qian, Qiaoxia; Zhou, Jingru; Ma, Yanyun; Mei, Zhendong; Chen, Xiangxiang; Li, Yuan; Yuan, Ziyu; Zhang, Juan; Yang, Yajun; Chen, Xingdong; Jin, Li; Zou, Hejian; Wang, Xiaofeng; Wang, Jiucun

    2017-01-01

    Aim A Mendelian randomization study (MRS) can be linked to a “natural” randomized controlled trial in order to avoid potential bias of observational epidemiology. We aimed to study the possible association between serum urate (SU) and total bilirubin (TBIL) using MRS. Materials and Methods An observational epidemiological study using ordinary least squares (OLS) regression and MRS using two-stage least square (TLS) regression was conducted to assess the effect of SU on TBIL. The comparison between the OLS regression and the TLS regression was analyzed by the Durbin-Hausman test. If the p value is significant, it suggests that the OLS regression cannot evaluate the relationship between exposure and outcome, and the TLS regression is precise; while if the p value is not significant, there would be no significant difference between the two regressions. Results A total of 3,753 subjects were analyzed. In OLS regression, there was no significant association between SU and TBIL in all subjects and subgroup analysis (all p > 0.05). However, MRS revealed a negative correlation between SU and TBIL after adjustment for confounders (beta = –0.021, p = 0.010). Further analysis was conducted in different SU subgroups, and results show that elevated SU was associated with a significant reduction in TBIL after adjustment for hyperuricemic subjects (beta = –0.053, p = 0.027). In addition, the results using the Durbin-Hausman test further confirmed a negative effect of SU on TBIL (p = 0.002 and 0.010, respectively). Conclusions This research shows for the first time that elevated SU was a potential causal factor in the reduction of TBIL and it provides strong evidence to resolve the controversial association between SU and TBIL. PMID:29262606

  10. 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

  11. 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

  12. 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 (treatment period, and a 4-week washout period. Participants will record their sleep duration, exercise, caffeine, and medication intake daily. Participants will record their fatigue using the Visual Analogue Fatigue Scale (VAFS) 4 times every third day, providing snapshots of their fatigue level at different times of day. Participants will self-report their fatigue severity using FSS on 3 separate visits: at baseline (week 0), following completion of the treatment phase (week 6), and at study completion (week 10). The primary outcome will be the change in the average FSS score after 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

  13. A randomized study of multimedia informational aids for research on medical practices: implications for informed consent

    Science.gov (United States)

    Kraft, Stephanie A; Constantine, Melissa; Magnus, David; Porter, Kathryn M.; Lee, Sandra Soo-Jin; Green, Michael; Kass, Nancy E; Wilfond, Benjamin S.; Cho, Mildred K

    2016-01-01

    Background/aims Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. Methods We administered a Web-based survey to members of a proprietary online panel sample selected to match national U.S. demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voiceover, comics, and text), and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used ANOVA and paired t-tests to compare knowledge scores between arms. Results There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voiceover (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voiceover and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voiceover) had higher knowledge scores than those without an audio component (64.2% versus 59.0%, peffectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the

  14. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

    Science.gov (United States)

    Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-09-01

    This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

  15. Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Seo, Jung-Chul; Lee, Hyun-jong; Kwak, Min-Ah; Park, Sung-Hoon; Shin, ImHee; Yun, Woo-Sung; Park, Kihyuk

    2014-09-04

    Cold hands sensation is a common disorder within the Korean population. Many Korean family physicians believe that it is a mild early manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress, and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands. However, this has not shown a clear benefit, and these medications can cause unwanted side effects. It is also reported that traditional Korean medicine, including acupuncture, is widely used to treat cold hands, although the current level of evidence for this approach is also poor and to date, there have been no published randomized controlled clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold hands. We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial. The proposed study is a five-week pilot RCT. A total of 14 subjects will be recruited and randomly allocated to two groups: an acupuncture plus medication group (experimental group) and a medication-only group (control group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg three times daily) for three weeks. The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks (nine sessions total). The primary outcome will be measured using a visual analogue scale. Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands, frequency and duration of episodes of cold hands, and heart rate variability. Assessments will be made at baseline and at one, three, and five weeks thereafter. This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial. This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the

  16. A randomized clinical study of two interceptive approaches to palatally displaced canines.

    Science.gov (United States)

    Baccetti, Tiziano; Leonardi, Maria; Armi, Pamela

    2008-08-01

    This study evaluated the effectiveness of two interceptive approaches to palatally displaced canines (PDC), i.e. extraction of the primary canines alone or in association with the use of a cervical-pull headgear. The randomized prospective design comprised 75 subjects with PDC (92 maxillary canines) who were randomly assigned to three groups: extraction of the primary canine only (EG), extraction of the primary canine and cervical-pull headgear (EHG), and an untreated control group (CG). Panoramic radiographs were evaluated at the time of initial observation (T1) and after an average period of 18 months (T2). At T2, an evaluation of the success of canine eruption was undertaken. Between-group statistical comparisons, Kruskal-Wallis test with Bonferroni correction, were performed on the T1-T2 changes of the diagnostic parameters on panoramic radiographs and the prevalence rates of success in canine eruption. A superimposition study on lateral cephalograms at T1 and T2 was carried out to evaluate the changes in the sagittal position of the upper molars in the three groups. The removal of the primary canine as an isolated measure to intercept palatal displacement of maxillary canines showed a success rate of 65.2 per cent, which was significantly greater than that in the untreated controls (36 per cent). The additional use of a headgear resulted in successful eruption in 87.5 per cent of the subjects, with a significant improvement in the measurements for intraosseous canine position. The cephalometric superimposition study showed a significant mesial movement of the upper first molars in the CG and EG when compared with the EHG.

  17. 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.

  18. 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.

  19. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

    Science.gov (United States)

    Edwards, Janet P; Kelly, Elizabeth J; Lin, Yongtao; Lenders, Taryn; Ghali, William A; Graham, Andrew J

    2012-06-01

    Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

  20. 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

  1. Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

    Science.gov (United States)

    Clayton, Anita H; Croft, Harry A; Yuan, James; Brown, Louise; Kissling, Robert

    2018-01-01

    Depression is often associated with sexual dysfunction, and pharmacologic treatment for hypoactive sexual desire disorder can be considered in women receiving treatment for depression. To evaluate the safety of flibanserin in women treated for depression with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. In this double-blinded, randomized, placebo-controlled trial, women with remitted or mild depression treated with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors who were not postmenopausal and were experiencing symptoms of hypoactive sexual desire disorder (ie, decreased sexual desire and related distress) received flibanserin 50 mg at bedtime (qhs) for 2 weeks and up-titrated to 100 mg qhs, flibanserin 100 mg qhs for the entire treatment period, or placebo for up to 12 weeks. Safety assessment included adverse events and symptoms of depression and anxiety. 73 patients were randomly assigned to flibanserin (both dose groups combined) and 38 to placebo. The sponsor terminated the study early at discontinuation of the development of flibanserin. Treatment duration was at least 8 weeks for 84.9% and 94.7% of patients in the flibanserin and placebo groups, respectively. The most common adverse events (incidence ≥ 2% in the flibanserin group and higher than that in the placebo group) included dry mouth (5.5% for flibanserin vs 2.6% for placebo), insomnia (5.5% vs 2.6%), back pain (4.1% vs 2.6%), and dizziness (4.1% vs 0.0%). There were no serious adverse events and no instances of suicidal ideation or behavior. The proportions of patients with symptom worsening in the flibanserin and placebo groups, respectively, were 6.9% and 21.6% for depression and 1.4% and 2.7% for anxiety. Remission of depression at study end point, as measured by the Quick Inventory of Depressive Symptomatology-Self Report, was experienced by 19.4% of flibanserin-treated patients and 10.8% of patients

  2. 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

  3. Zero Distribution of System with Unknown Random Variables Case Study: Avoiding Collision Path

    Directory of Open Access Journals (Sweden)

    Parman Setyamartana

    2014-07-01

    Full Text Available This paper presents the stochastic analysis of finding the feasible trajectories of robotics arm motion at obstacle surrounding. Unknown variables are coefficients of polynomials joint angle so that the collision-free motion is achieved. ãk is matrix consisting of these unknown feasible polynomial coefficients. The pattern of feasible polynomial in the obstacle environment shows as random. This paper proposes to model the pattern of this randomness values using random polynomial with unknown variables as coefficients. The behavior of the system will be obtained from zero distribution as the characteristic of such random polynomial. Results show that the pattern of random polynomial of avoiding collision can be constructed from zero distribution. Zero distribution is like building block of the system with obstacles as uncertainty factor. By scale factor k, which has range, the random coefficient pattern can be predicted.

  4. Warm-up for Sprint Swimming: Race-Pace or Aerobic Stimulation? A Randomized Study.

    Science.gov (United States)

    Neiva, Henrique P; Marques, Mário C; Barbosa, Tiago M; Izquierdo, Mikel; Viana, João L; Teixeira, Ana M; Marinho, Daniel A

    2017-09-01

    Neiva, HP, Marques, MC, Barbosa, TM, Izquierdo, M, Viana, JL, Teixeira, AM, and Marinho, DA. Warm-up for sprint swimming: race-pace or aerobic stimulation? A randomized study. J Strength Cond Res 31(9): 2423-2431, 2017-The aim of this study was to compare the effects of 2 different warm-up intensities on 100-m swimming performance in a randomized controlled trial. Thirteen competitive swimmers performed two 100-m freestyle time-trials on separate days after either control or experimental warm-up in a randomized design. The control warm-up included a typical race-pace set (4 × 25 m), whereas the experimental warm-up included an aerobic set (8 × 50 m at 98-102% of critical velocity). Cortisol, testosterone, blood lactate ([La]), oxygen uptake (V[Combining Dot Above]O2), heart rate, core (Tcore and Tcorenet) and tympanic temperatures, and rating of perceived exertion (RPE) were monitored. Stroke length (SL), stroke frequency (SF), stroke index (SI), and propelling efficiency (ηp) were assessed for each 50-m lap. We found that V[Combining Dot Above]O2, heart rate, and Tcorenet were higher after experimental warm-up (d > 0.73), but only the positive effect for Tcorenet was maintained until the trial. Performance was not different between conditions (d = 0.07). Experimental warm-up was found to slow SF (mean change ±90% CL = 2.06 ± 1.48%) and increase SL (1.65 ± 1.40%) and ηp (1.87 ± 1.33%) in the first lap. After the time-trials, this warm-up had a positive effect on Tcorenet (d = 0.69) and a negative effect on [La] (d = 0.56). Although the warm-ups had similar outcomes in the 100-m freestyle, performance was achieved through different biomechanical strategies. Stroke length and efficiency were higher in the first lap after the experimental warm-up, whereas SF was higher after control warm-up. Physiological adaptations were observed mainly through an increased Tcore after experimental warm-up. In this condition, the lower [La] after the trial suggests lower

  5. Feasibility and effects of the semirecumbent position to prevent ventilator-associated pneumonia: a randomized study.

    Science.gov (United States)

    van Nieuwenhoven, Christianne A; Vandenbroucke-Grauls, Christine; van Tiel, Frank H; Joore, Hans C A; van Schijndel, Rob J M Strack; van der Tweel, Ingeborg; Ramsay, Graham; Bonten, Marc J M

    2006-02-01

    Reducing aspiration of gastric contents by placing mechanically ventilated patients in a semirecumbent position has been associated with lower incidences of ventilator-associated pneumonia (VAP). The feasibility and efficacy of this intervention in a larger patient population, however, are unknown. Assessment of the feasibility of the semirecumbent position for intensive care unit patients and its influence on development of VAP. In a prospective multicentered trial, critically ill patients undergoing mechanical ventilation were randomly assigned to the semirecumbent position, with a target backrest elevation of 45 degrees , or standard care (i.e., supine position) with a backrest elevation of 10 degrees . Backrest elevation was measured continuously during the first week of ventilation with a monitor-linked device. A deviation of position was defined as a change of the randomized position >5 degrees . Diagnosis of VAP was made by quantitative cultures of samples obtained by bronchoscopic techniques. One hundred nine patients were assigned to the supine group and 112 to the semirecumbent group. Baseline characteristics were comparable for both groups. Average elevations were 9.8 degrees and 16.1 degrees at day 1 and day 7, respectively, for the supine group and 28.1 degrees and 22.6 degrees at day 1 and day 7, respectively, for the semirecumbent group (p position of 45 degrees was not achieved for 85% of the study time, and these patients more frequently changed position than supine-positioned patients. VAP was diagnosed in eight patients (6.5%) in the supine group and in 13 (10.7%) in the semirecumbent group (NS), after a mean of 6 (range, 3-9) and 7 (range, 3-12) days, respectively. There were no differences in numbers of patients undergoing enteral feeding, receiving stress ulcer prophylaxis, or developing pressure sores or in mortality rates or duration of ventilation and intensive care unit stay between the groups. The targeted backrest elevation of 45 degrees

  6. A randomized study of the prevention of acute graft-versus-host disease

    International Nuclear Information System (INIS)

    Ramsay, N.K.C.; Kersey, J.H.; Robison, L.L.; McGlave, P.B.; Woods, W.G.; Krivit, W.; Kim, T.H.; Goldman, A.I.; Nesbit, M.E. Jr.

    1982-01-01

    Acute graft-versus-host disease is a major problem in allogeneic bone-marrow transplantation. We performed a randomized study to compare the effectiveness of two regimens in the prevention of acute graft-versus-host disease. Thirty-five patients received methotrexate alone, and 32 received methotrexate, antithymocyte globulin, and prednisone. Of the patients who received methotrexate alone, 48 percent had acute graft-versus-host disease, as compared with 21 per cent of those who received methotrexate, antithymocyte globulin, and prednisone (P = 0.01). The age of the recipient was a significant factor in the development of acute graft-versus-host disease: Older patients had a higher incidence of the disease (P = 0.001). We conclude that the combination of methotrexate, antithymocyte globulin, and prednisone significantly decreased the incidence of acute graft-versus-host disease and should be used to prevent this disorder in patients receiving allogeneic marrow transplants

  7. Modeling of Residential Water Demand Using Random Effect Model,Case Study: Arak City

    Directory of Open Access Journals (Sweden)

    Seyed Hossein Sajadifar

    2011-10-01

    Full Text Available The present study tries to apply the “Partial Adjustment Model” and “Random Effect Model” techniques to the Stone-Greay’s linear expenditure system, in order to estimate the "Residential Seasonal Demand" for water in Arak city. Per capita water consumption of family residences is regressed on marginal price, per capita income, price of other goods, average temperature and average rainfall. Panel data approaches based on a sample of 152 observations from Arak city referred to 1993-2003. From the estimation of the Elasticity-price of the residential water demand, we want to know how a policy of responsive pricing can lead to more efficient household water consumption inArakcity. Results also indicated that summer price elasticity was twice the winter and price and income elasticity was less than 1 in all cases.

  8. A Radical Sodium Reduction Policy is not Supported by Randomized Controlled Trials or Observational Studies

    DEFF Research Database (Denmark)

    Graudal, Niels

    2016-01-01

    Several health institutions recommend sodium intake be reduced to below 2,300 mg, which means that 6-7 billion individuals should alter their diet to accommodate. Such a radical recommendation should be based on solid evidence. However, this review reveals that (i) there are no randomized...... controlled trials (RCTs) allocating individuals to below 2,300 mg and measuring health outcomes; (ii) RCTs allocating risk groups such as obese prehypertensive individuals and hypertensive individuals down to (but not below) 2,300 mg show no effect of sodium reduction on all-cause mortality; (iii) RCTs...... allocating individuals to below 2,300 mg show a minimal effect on blood pressure in the healthy population (less than 1mm Hg) and significant increases in renin, aldosterone, noradrenalin cholesterol, and triglyceride; and (iv) observational studies show that sodium intakes below 2,645 and above 4,945 mg...

  9. Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

    Science.gov (United States)

    Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

    1989-08-01

    In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

  10. Random Forest Approach to QSPR Study of Fluorescence Properties Combining Quantum Chemical Descriptors and Solvent Conditions.

    Science.gov (United States)

    Chen, Chia-Hsiu; Tanaka, Kenichi; Funatsu, Kimito

    2018-04-22

    The Quantitative Structure - Property Relationship (QSPR) approach was performed to study the fluorescence absorption wavelengths and emission wavelengths of 413 fluorescent dyes in different solvent conditions. The dyes included the chromophore derivatives of cyanine, xanthene, coumarin, pyrene, naphthalene, anthracene and etc., with the wavelength ranging from 250 nm to 800 nm. An ensemble method, random forest (RF), was employed to construct nonlinear prediction models compared with the results of linear partial least squares and nonlinear support vector machine regression models. Quantum chemical descriptors derived from density functional theory method and solvent information were also used by constructing models. The best prediction results were obtained from RF model, with the squared correlation coefficients [Formula: see text] of 0.940 and 0.905 for λ abs and λ em , respectively. The descriptors used in the models were discussed in detail in this report by comparing the feature importance of RF.

  11. The Effect of Preoperative Oral Carbohydrate Solution Intake on Patient Comfort: A Randomized Controlled Study.

    Science.gov (United States)

    Çakar, Emel; Yilmaz, Emel; Çakar, Ekrem; Baydur, Hakan

    2017-12-01

    The study was conducted to investigate the effect of preoperative oral carbohydrate loading on the preoperative discomforts and postoperative complications of patients undergoing elective thyroidectomy. A randomized controlled clinical trial. Ninety patients scheduled for thyroidectomy were divided into three groups: (1) those receiving a carbohydrate-rich drink (CHD), (2) those receiving an overnight 5% glucose intravenous infusion, and (3) those fasting from midnight. The preoperative discomforts and postoperative complications of patients were evaluated using the Visual Analog Scale (VAS). The patients' vital signs and blood glucose levels were measured perioperatively. In the preoperative assessment, hunger, thirst, mouth dryness, chill, and headache adjusted for age, gender, body mass index, and duration of the operation were all found to be significantly higher in the glucose and fasting groups than the CHD group (P hunger, thirst, dry mouth, fatigue and headache) and early postoperative complications (vomiting and pain). Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

  12. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related...... to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.Methods: The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group...... paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.Discussion: The trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive...

  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. 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.

  15. 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.

  16. Simulation study of localization of electromagnetic waves in two-dimensional random dipolar systems

    International Nuclear Information System (INIS)

    Wang, Ken Kang-Hsin; Ye Zhen

    2003-01-01

    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

  17. 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.

  18. Comparative Effectiveness of Three Occupational Therapy Sleep Interventions: A Randomized Controlled Study.

    Science.gov (United States)

    Gutman, Sharon A; Gregory, Kristin A; Sadlier-Brown, Megan M; Schlissel, Marcy A; Schubert, Allison M; Westover, Lee Ann; Miller, Richard C

    2017-01-01

    Although sleep intervention is within the domain of occupational therapy, few studies exist supporting practice. Effectiveness of three sleep interventions was compared: Dreampad Pillow®, iRest® meditation, and sleep hygiene. Twenty-nine participants were randomly assigned to the Dreampad Pillow® ( n = 10), iRest® meditation ( n = 9), and sleep hygiene ( n = 10) groups. In Phase 1, all participants used a 7-day sleep hygiene regimen to reduce poor sleep habits. In Phase 2 (14 days), 10 participants used the Dreampad Pillow® and sleep hygiene, nine used the iRest meditation and sleep hygiene, and 10 continued sleep hygiene only. At intervention-end, the iRest meditation group experienced statistically greater time asleep than both the Dreampad Pillow® ( p meditation ( p occupational therapy's domain.

  19. Follow-up services for stroke survivors after hospital discharge--a randomized control study

    DEFF Research Database (Denmark)

    Andersen, Hanne Elkjaer; Eriksen, Karen; Brown, Anne

    2002-01-01

    OBJECTIVE: To evaluate whether follow-up services for stroke survivors could improve functional outcome and reduce readmission rate. In this paper results of functional outcome are reported. DESIGN: Randomized controlled trial allocating patients to one of three different types of aftercare: (1......) follow-up home visits by a physician, (2) physiotherapist instruction in the patient's home, or (3) standard aftercare. SUBJECTS: Stroke patients with persisting impairment and disability who, after completing inpatient rehabilitation, were discharged to their homes. OUTCOME MEASURES: Six months after...... discharge, functional outcome was assessed with Functional Quality of Movement, Barthel Index, Frenchay Activity Index and Index of Extended Activites of Daily Living. RESULTS: One-hundred and fifty-five stroke patients were included in the study. Fifty-four received follow-up home visits by a physician, 53...

  20. A Randomized Study of Incentivizing HIV Testing for Parolees in Community Aftercare.

    Science.gov (United States)

    Saxena, Preeta; Hall, Elizabeth A; Prendergast, Michael

    2016-04-01

    HIV risk-behaviors are high in criminal justice populations and more efforts are necessary to address them among criminal justice-involved substance abusers. This study examines the role of incentives in promoting HIV testing among parolees. Participants were randomly assigned to either an incentive (n = 104) or education group (control; n = 98), where the incentive group received a voucher for testing for HIV. Bivariate comparisons showed that a larger proportion of those in the incentive group received HIV testing (59% versus 47%), but this was not statistically significant (p = .09). However, in a multivariate logistic regression model controlling for covariates likely to influence HIV-testing behavior, those in the incentive group had increased odds of HIV testing in comparison to those in the education group (OR = 1.99, p testing and other healthy behaviors in criminal justice populations.

  1. 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

    team leaders rejected randomization because they considered it to be fairest to increase work-time control among employees in most need. Others accepted randomization arguing that it was fairer to allocate a potential benefi t by random. We found no difference in readiness for changes when comparing...... 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’....

  2. A simulation study on estimating biomarker-treatment interaction effects in randomized trials with prognostic variables.

    Science.gov (United States)

    Haller, Bernhard; Ulm, Kurt

    2018-02-20

    To individualize treatment decisions based on patient characteristics, identification of an interaction between a biomarker and treatment is necessary. Often such potential interactions are analysed using data from randomized clinical trials intended for comparison of two treatments. Tests of interactions are often lacking statistical power and we investigated if and how a consideration of further prognostic variables can improve power and decrease the bias of estimated biomarker-treatment interactions in randomized clinical trials with time-to-event outcomes. A simulation study was performed to assess how prognostic factors affect the estimate of the biomarker-treatment interaction for a time-to-event outcome, when different approaches, like ignoring other prognostic factors, including all available covariates or using variable selection strategies, are applied. Different scenarios regarding the proportion of censored observations, the correlation structure between the covariate of interest and further potential prognostic variables, and the strength of the interaction were considered. The simulation study revealed that in a regression model for estimating a biomarker-treatment interaction, the probability of detecting a biomarker-treatment interaction can be increased by including prognostic variables that are associated with the outcome, and that the interaction estimate is biased when relevant prognostic variables are not considered. However, the probability of a false-positive finding increases if too many potential predictors are included or if variable selection is performed inadequately. We recommend undertaking an adequate literature search before data analysis to derive information about potential prognostic variables and to gain power for detecting true interaction effects and pre-specifying analyses to avoid selective reporting and increased false-positive rates.

  3. 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

  4. Treatment of hypothyroidism with levothyroxine plus liothyronine: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Kaminski, Juliana; Miasaki, Fabíola Yukiko; Paz-Filho, Gilberto; Graf, Hans; Carvalho, Gisah Amaral de

    2016-01-01

    To compare the effects of a unique fixed combination levothyroxine/liothyronine (LT4/LT3) therapy in patients with primary hypothyroidism. This is a randomized, double-blind, crossover study. Adults with primary hypothyroidism (n = 32, age 42.6 ± 13.3, 30 females) on stable doses of LT4 for ≥ 6 months (125 or 150 μg/day) were randomized to continue LT4 treatment (G1) or to start LT4/LT3 therapy (75/15 μg/day; G2). After 8 weeks, participants switched treatments for 8 more weeks. Thyroid function, lipid profile, plasma glucose, body weight, electrocardiogram, vital signs, and quality of life (QoL) were evaluated at weeks 0, 8 and 16. Free T4 levels were significantly lower while on LT4/LT3 (G1: 1.07 ± 0.29 vs. 1.65 ± 0.46; G2: 0.97 ± 0.26 vs. 1.63 ± 0.43 ng/dL; P < 0.001). TSH and T3 levels were not affected by type of therapy. More patients on LT4/LT3 had T3 levels above the upper limit (15% vs. 3%). The combination therapy led to an increase in heart rate, with no significant changes in electrocardiogram or arterial blood pressure. Lipid profile, body weight and QoL remained unchanged. The combination therapy yielded significantly lower free T4 levels, with no changes in TSH or T3 levels. More patients on LT4/T3 had elevated T3 levels, with no significant alterations in the evaluated outcomes. No clear clinical benefit of the studied formulation could be observed. Future trials need to evaluate different formulations and the impact of the combined therapy in select populations with genetic polymorphisms.

  5. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

    Science.gov (United States)

    Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

    2016-01-01

    To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

  6. Electrophysiological effects of desflurane in children with Wolff-Parkinson-White syndrome: a randomized crossover study.

    Science.gov (United States)

    Hino, H; Oda, Y; Yoshida, Y; Suzuki, T; Shimada, M; Nishikawa, K

    2018-02-01

    We hypothesized that, compared with propofol, desflurane prolongs the antegrade accessory pathway effective refractory period (APERP) in children undergoing radiofrequency catheter ablation for Wolff-Parkinson-White (WPW) syndrome. In this randomized crossover study, children aged 4.1-16.1 years undergoing radiofrequency catheter ablation for WPW syndrome were randomly divided into four groups according to the concentration of desflurane and anesthetics used in the first and the second electrophysiological studies (EPS). After induction of general anesthesia with propofol and tracheal intubation, they received one of the following regimens: 0.5 minimum alveolar concentration (MAC) desflurane (first EPS) and propofol (second EPS) (Des0.5-Prop group, n = 8); propofol (first EPS) and 0.5 MAC desflurane (second EPS) (Prop-Des0.5 group, n = 9); 1 MAC desflurane (first EPS) and propofol (second EPS) (Des1.0-Prop group, n = 10); propofol (first EPS) and 1 MAC desflurane (second EPS) (Prop-Des1.0 group, n = 9). Radiofrequency catheter ablation was performed upon completion of EPS. Sample size was determined to detect a difference in the APERP. Desflurane at 1.0 MAC significantly prolonged the APERP compared with propofol, but did not affect the sinoatrial conduction time, atrio-His interval or atrioventricular node effective refractory period. Supraventricular tachycardia was induced in all children receiving propofol, but not induced in 1 and 4 children receiving 0.5 MAC and 1.0 MAC desflurane, respectively. Desflurane enhances the refractoriness and may block the electrical conduction of the atrioventricular accessory pathway, and is therefore not suitable for use in children undergoing radiofrequency catheter ablation for WPW syndrome. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  7. E-learning in pediatric basic life support: a randomized controlled non-inferiority study.

    Science.gov (United States)

    Krogh, Lise Qvirin; Bjørnshave, Katrine; Vestergaard, Lone Due; Sharma, Maja Bendtsen; Rasmussen, Stinne Eika; Nielsen, Henrik Vendelbo; Thim, Troels; Løfgren, Bo

    2015-05-01

    Dissemination of pediatric basic life support (PBLS) skills is recommended. E-learning is accessible and cost-effective, but it is currently unknown whether laypersons can learn PBLS through e-learning. The hypothesis of this study was to investigate whether e-learning PBLS is non-inferior to instructor-led training. Participants were recruited among child-minders and parents of children aged 0-6 years. Participants were randomized to either 2-h instructor-led training or e-learning using an e-learning program (duration 17 min) including an inflatable manikin. After training, participants were assessed in a simulated pediatric cardiac arrest scenario. Tests were video recorded and PBLS skills were assessed independently by two assessors blinded to training method. Primary outcome was the pass rate of the PBLS test (≥8 of 15 skills adequately performed) with a pre-specified non-inferiority margin of 20%. In total 160 participants were randomized 1:1. E-learning was non-inferior to instructor-led training (difference in pass rate -4%; 95% CI -9:0.5). Pass rates were 100% among instructor-led trained (n=67) and 96% among e-learned (n=71). E-learners median time spent on the e-learning program was 30 min (range: 15-120 min) and the median number of log-ons was 2 (range: 1-5). After the study, all participants felt that their skills had improved. E-learning PBLS is non-inferior to instructor-led training among child-minders and parents with children aged 0-6 years, although the pass rate was 4% (95% CI -9:0.5) lower with e-learning. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  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. Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, Jiao; Feng, Shuwei; Zeng, Jiuzhi; Wu, Xi; Yang, Mingxiao; Tang, Hongzhi; Fan, Huaying; Yang, Jie; Liang, Fanrong

    2016-05-21

    Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome. This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial. The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome. Chinese Clinical Trial Registry, ChiCTR-IOR-15007358

  10. Effects of 5 Weeks of Bench Press Training on Muscle Synergies: A Randomized Controlled Study.

    Science.gov (United States)

    Kristiansen, Mathias; Samani, Afshin; Madeleine, Pascal; Hansen, Ernst A

    2016-07-01

    Kristiansen, M, Samani, A, Madeleine, P, and Hansen, EA. Effects of 5 weeks of bench press training on muscle synergies: A randomized controlled study. J Strength Cond Res 30(7): 1948-1959, 2016-The ability to perform forceful muscle contractions has important implications in sports performance and in activities of daily living. However, there is a lack of knowledge on adaptations in intermuscular coordination after strength training. The purpose of this study was therefore to assess muscle synergies before and after 5 weeks of bench press training. Thirty untrained male subjects were randomly allocated to a training group (TRA) or a control group (CON). After the pretest, TRA completed 5 weeks of bench press training, before completing a posttest, whereas subjects in CON continued their normal life. During test sessions, surface electromyography (EMG) was recorded from 13 different muscles. Muscle synergies were extracted from EMG data using nonnegative matrix factorization. To evaluate differences between pretest and posttest, we performed a cross-correlation analysis and a cross-validation analysis, in which the synergy components extracted in the pretest session were recomputed, using the fixed synergy components from the posttest session. Two muscle synergies accounted for 90% of the total variance and reflected the concentric and eccentric phase, respectively. TRA significantly increased 3 repetition maximum in bench press with 19.0% (25th; 75th percentile, 10.3%; 21.7%) (p < 0.001), whereas no change occurred in CON. No significant differences were observed in synergy components between groups. However, decreases in correlation values for intragroup comparisons in TRA may suggest that the synergy components changed, whereas this was not the case in CON. Strength and conditioning professionals may consider monitoring changes in muscle synergies in training and rehabilitation programs as a way to benchmark changes in intermuscular coordination.

  11. Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.

    Science.gov (United States)

    Sørensen, P S; Sellebjerg, F; Lycke, J; Färkkilä, M; Créange, A; Lund, C G; Schluep, M; Frederiksen, J L; Stenager, E; Pfleger, C; Garde, E; Kinnunen, E; Marhardt, K

    2016-05-01

    Combining different therapies may improve disease control in patients with relapsing-remitting multiple sclerosis (RRMS). This study assessed the efficacy and safety of minocycline added to subcutaneous (sc) interferon (IFN) β-1a therapy. This was a double-blind, randomized, placebo-controlled multicentre study. Within 3 months (±1 month) of starting sc IFN β-1a 44 μg three times weekly, patients with RRMS were randomized to minocycline 100 mg twice daily or placebo, added to sc IFN β-1a, for 96 weeks. The primary efficacy endpoint was the time to first qualifying relapse. Secondary efficacy endpoints were the annualized relapse rate for qualifying relapses, the number of new/enlarging T2-weighted lesions and change in brain volume [magnetic resonance imaging (MRI) was performed only in a few selected centres]. In addition, a number of tertiary efficacy endpoints were assessed. One hundred and forty-nine patients received minocycline and 155 received placebo; MRI data were available for 23 and 27 patients, respectively. The time to first qualifying relapse did not differ significantly for minocycline versus placebo (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 0.48). There were no statistically significant differences between the two groups on other efficacy endpoints, although some numerical trends in favour of minocycline were observed. No unexpected adverse events were reported, but more patients discontinued because of adverse events with minocycline versus placebo. Minocycline showed no statistically significant beneficial effect when added to sc IFN β-1a therapy. © 2016 EAN.

  12. Management of Pleural Space After Lung Resection by Cryoneuroablation of Phrenic Nerve: A Randomized Study.

    Science.gov (United States)

    Pan, Xiao-Jie; Ou, De-Bin; Lin, Xing; Ye, Ming-Fang

    2017-06-01

    Residual air space problems after pulmonary lobectomy are an important concern in thoracic surgical practice, and various procedures have been applied to manage them. This study describes a novel technique using controllable paralysis of the diaphragm by localized freezing of the phrenic nerve, and assesses the effectiveness of this procedure to reduce air space after pulmonary lobectomy. In this prospective randomized study, 207 patients who underwent lobectomy or bilobectomy and systematic mediastinal node dissection in our department between January 2009 and November 2013 were randomly allocated to a cryoneuroablation group or a conventional group. Patients in the cryoneuroablation group (n = 104) received phrenic nerve cryoneuroablation after lung procedures, and patients in the conventional group (n = 103) did not receive cryoneuroablation after the procedure. Data regarding preoperative clinical and surgical characteristics in both groups were collected. Both groups were compared with regard to postoperative parameters such as total amount of pleural drainage, duration of chest tube placement, length of hospital stay, requirement for repeat chest drain insertion, prolonged air leak, and residual space. Perioperative lung function was also compared in both groups. Recovery of diaphragmatic movement in the cryoneuroablation group was checked by fluoroscopy on the 15th, 30th, and 60th day after surgery. There was no statistically significant difference in patient characteristics between the 2 groups; nor was there a difference in terms of hospital stay, new drain requirement, and incidence of empyema. In comparison with the conventional group, the cryoneuroablation group had less total drainage (1024 ± 562 vs 1520 ± 631 mL, P phrenic nerve offers a reasonable option for prevention of residual air space following major pulmonary resection.

  13. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Science.gov (United States)

    Ivanov, Iliya V; Mackeben, Manfred; Vollmer, Annika; Martus, Peter; Nguyen, Nhung X; Trauzettel-Klosinski, Susanne

    2016-01-01

    Degenerative retinal diseases, especially retinitis pigmentosa (RP), lead to severe peripheral visual field loss (tunnel vision), which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST). Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses) that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental) and reading (control) training. All subjects who first performed reading training underwent experimental training later (waiting list control group). To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT) during exploratory saccade training, Percent Preferred Walking Speed (PPWS), the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field. In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training condition

  14. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

    Science.gov (United States)

    Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

    2011-12-01

    This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

  15. 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.

  16. 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.

  17. 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)...

  18. 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.

  19. How Should Debriefing Be Undertaken in Web-Based Studies? Findings From a Randomized Controlled Trial

    Science.gov (United States)

    Kypri, Kypros; Wilson, Amanda

    2012-01-01

    Background 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. Objective 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. Methods 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. Results 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. Conclusions 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

  20. EFFECT OF FLAXSEED OIL IN PLAQUE INDUCED GINGIVITIS- A RANDOMIZED CONTROLLED DOUBLE-BLIND STUDY

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    Alluru Deepika

    2018-02-01

    Full Text Available BACKGROUND Oil pulling has been used extensively as a traditional remedy for many years. It is supposed to cure oral and systemic diseases, but the evidence is minimal. Intraorally it is supposed to cause strengthening of teeth, gums, and the jaw and to prevent decay, oral malodour, bleeding gums, dryness of the throat and cracked lips. The aim of this study was to evaluate the effect of oil pulling with flaxseed oil on plaque induced gingivitis and to compare its efficacy with chlorhexidine mouthwash. MATERIALS AND METHODS A total of 20 teenaged individuals attending the Out Patient - Department of Dentistry with plaque-induced gingivitis were selected for this study. They were divided randomly into the study or oil pulling group (Group I and the control or chlorhexidine group (Group II with 10 subjects in each group. Plaque index and modified gingival index scores were recorded for the selected individuals of both the groups. The study group was subjected to oil pulling with flaxseed oil every day in the morning before brushing whereas the control group used chlorhexidine mouth rinse. Reassessment of the index scores was done after 30 days in both the groups. RESULTS There was a statistically significant reduction of the pre- and post-values of the plaque and modified gingival index scores in both the study and control groups (P <0.001. CONCLUSION The oil pulling therapy with flaxseed oil is thus an effective adjuvant in reducing plaque-induced gingivitis.

  1. Treatment of Upper Respiratory Tract Infections in Primary Care: A Randomized Study Using Aromatic Herbs

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    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.

  2. Transcranial magnetic stimulation in the treatment of chronic widespread pain: a randomized controlled study.

    Science.gov (United States)

    Avery, David H; Zarkowski, Paul; Krashin, Daniel; Rho, Wang-Ku; Wajdik, Chandra; Joesch, Jutta M; Haynor, David R; Buchwald, Dedra; Roy-Byrne, Peter

    2015-03-01

    Our objective was to assess transcranial magnetic stimulation (TMS) in the treatment of chronic widespread pain. Nineteen participants were randomized into 2 groups: one group receiving active TMS (n = 7) and another group receiving sham stimulation (n = 11) applied to the left dorsolateral prefrontal cortex. During sham stimulation, subjects heard a sound similar to the sound heard by those receiving the active treatment and received an active electrical stimulus to the scalp. The stimulation protocol consisted of 15 sessions completed within a 4-week period. Blind assessments were done at baseline and after each 5 sessions followed by blind assessments at 1 week, 1 month, and 3 months after the last TMS sessions. The primary outcome variable was a pain measure, the Gracely Box Intensity Scale (BIRS). The percentage of subjects who guessed that they were receiving TMS was similar in the 2 groups. Both the TMS group and the sham group showed a statistically significant reduction in the BIRS scores from baseline during the acute phase of treatment and the follow-up phase. However, the TMS and sham groups did not differ in the change in the BIRS scores. Although some previous clinical studies and basic science studies of TMS in treating pain are promising, this study found no difference in the analgesic effect of TMS and sham stimulation. Future studies should use a sham condition that attempts to simulate the sound and sensation of the TMS stimulation. Stimulus location and other stimulus parameters should be explored in future studies.

  3. 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.

  4. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

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    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  5. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

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    Ubbink Dirk T

    2011-10-01

    Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such

  6. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

    Science.gov (United States)

    De Pascale, Gennaro; Pennisi, Mariano Alberto; Vallecoccia, Maria Sole; Bello, Giuseppe; Maviglia, Riccardo; Montini, Luca; Di Gravio, Valentina; Cutuli, Salvatore Lucio; Conti, Giorgio; Antonelli, Massimo

    2017-01-01

    To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS). This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually. No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; paspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality. The use AG 100 system and AG tube in critically ill intubated patients is safe and

  7. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Gennaro De Pascale

    Full Text Available To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system that continuously monitors and controls the cuff pressure (Pcuff, while facilitating the aspiration of subglottic secretions (SS.This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE and serious AE (SAE as a result of using AnapnoGuard (AG 100 during mechanical ventilation. Secondary endpoints were: (1 mechanical complications rate (2 ICU staff satisfaction; (3 VAP occurrence; (4 length of mechanical ventilation; (5 length of Intensive Care Unit stay and mortality; (6 volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually.No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01 and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total; (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily. No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7, hoarseness (42.9% vs. 75%; p = 0.55 and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65. Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP (14.8% vs. 40%; p = 0.06, which were more frequently monomicrobial (25% vs. 70%; p = 0.03. No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality.The use AG 100 system and AG tube in critically ill

  8. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

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    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  9. Reducing intrusive traumatic memories after emergency caesarean section: A proof-of-principle randomized controlled study.

    Science.gov (United States)

    Horsch, Antje; Vial, Yvan; Favrod, Céline; Harari, Mathilde Morisod; Blackwell, Simon E; Watson, Peter; Iyadurai, Lalitha; Bonsall, Michael B; Holmes, Emily A

    2017-07-01

    Preventative psychological interventions to aid women after traumatic childbirth are needed. This proof-of-principle randomized controlled study evaluated whether the number of intrusive traumatic memories mothers experience after emergency caesarean section (ECS) could be reduced by a brief cognitive intervention. 56 women after ECS were randomized to one of two parallel groups in a 1:1 ratio: intervention (usual care plus cognitive task procedure) or control (usual care). The intervention group engaged in a visuospatial task (computer-game 'Tetris' via a handheld gaming device) for 15 min within six hours following their ECS. The primary outcome was the number of intrusive traumatic memories related to the ECS recorded in a diary for the week post-ECS. As predicted, compared with controls, the intervention group reported fewer intrusive traumatic memories (M = 4.77, SD = 10.71 vs. M = 9.22, SD = 10.69, d = 0.647 [95% CI: 0.106, 1.182]) over 1 week (intention-to-treat analyses, primary outcome). There was a trend towards reduced acute stress re-experiencing symptoms (d = 0.503 [95% CI: -0.032, 1.033]) after 1 week (intention-to-treat analyses). Times series analysis on daily intrusions data confirmed the predicted difference between groups. 72% of women rated the intervention "rather" to "extremely" acceptable. This represents a first step in the development of an early (and potentially universal) intervention to prevent postnatal posttraumatic stress symptoms that may benefit both mother and child. ClinicalTrials.gov, www.clinicaltrials.gov, NCT02502513. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Effects of Fluoxetine on Neural Functional Prognosis after Ischemic Stroke: A Randomized Controlled Study in China.

    Science.gov (United States)

    He, Yi-Tao; Tang, Bing-Shan; Cai, Zhi-Li; Zeng, Si-Ling; Jiang, Xin; Guo, Yi

    2016-04-01

    We investigated the effects of fluoxetine on the short-term and long-term neural functional prognoses after ischemic stroke. In this prospective randomized controlled single-blind clinical study in China, eligible patients afflicted with ischemic stroke were randomized into control and treatment groups. Patients in the treatment group received fluoxetine in addition to the basic therapies in the control group over a period of 90 days. The follow-up period was 180 days. We evaluated the effects of fluoxetine on the National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score after ischemic stroke through single- and multiple-factor analysis. The mean NIHSS score on day 180 after treatment was significantly lower in the treatment group than in the control group (P = .009). The mean BI scores on days 90 and 180 were significantly higher in the treatment group (P = .026) than in the control group (P = .011). The improvements in the NIHSS and BI scores on days 90 and 180 compared with baseline in the treatment group were all significantly greater than that in the control group (P = .033, P = .013, P = .013, P = .019, respectively). Treatment with fluoxetine was an independent factor affecting the NIHSS and BI scores on day 180 after treatment. Treatment with fluoxetine for 90 days after ischemic stroke can improve the long-term neural functional outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  11. Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Feng; Li, Wen-Xiong; Liu, Zhu; Liu, Li

    2016-10-22

    Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved. We propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial. If BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated. Clinical Trials.gov Identifier: NCT02705131 . Registered on 9

  12. A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease.

    Science.gov (United States)

    2004-04-01

    Treatment with rasagiline mesylate, an irreversible monoamine oxidase type B inhibitor, improves symptoms of early Parkinson disease (PD). Preclinical studies suggest that this compound may also modify the progression of PD. To compare the effects of early and later initiation of rasagiline on progression of disability in patients with PD. Double-blind, parallel-group, randomized, delayed-start clinical trial. Four hundred four subjects with early PD, not requiring dopaminergic therapy, enrolled at 32 sites in the United States and Canada. Subjects were randomized to receive rasagiline, 1 or 2 mg/d, for 1 year or placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months. Change in total Unified Parkinson's Disease Rating Scale score from baseline to 12 months. Three hundred seventy-one subjects were included in the 1-year efficacy analysis. Subjects treated with rasagiline, 2 mg/d, for 1 year had a 2.29-unit smaller increase in mean adjusted total Unified Parkinson's Disease Rating Scale score compared with subjects treated with placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months (P =.01). The mean adjusted difference between the placebo/rasagiline, 2 mg/d, group and those receiving rasagiline, 1 mg/d, for 1 year was -1.82 unit on the Unified Parkinson's Disease Rating Scale score (P =.05). Subjects treated with rasagiline, 2 and 1 mg/d, for 12 months showed less functional decline than subjects whose treatment was delayed for 6 months.

  13. A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

    Science.gov (United States)

    Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

    2018-01-01

    Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  14. "Push as hard as you can" instruction for telephone cardiopulmonary resuscitation: a randomized simulation study.

    Science.gov (United States)

    van Tulder, Raphael; Roth, Dominik; Havel, Christof; Eisenburger, Philip; Heidinger, Benedikt; Chwojka, Christof Constantin; Novosad, Heinz; Sterz, Fritz; Herkner, Harald; Schreiber, Wolfgang

    2014-03-01

    The medical priority dispatch system (MPDS®) assists lay rescuers in protocol-driven telephone-assisted cardiopulmonary resuscitation (CPR). Our aim was to clarify which CPR instruction leads to sufficient compression depth. This was an investigator-blinded, randomized, parallel group, simulation study to investigate 10 min of chest compressions after the instruction "push down firmly 5 cm" vs. "push as hard as you can." Primary outcome was defined as compression depth. Secondary outcomes were participants exertion measured by Borg scale, provider's systolic and diastolic blood pressure, and quality values measured by the skill-reporting program of the Resusci(®) Anne Simulator manikin. For the analysis of the primary outcome, we used a linear random intercept model to allow for the repeated measurements with the intervention as a covariate. Thirteen participants were allocated to control and intervention. One participant (intervention) dropped out after min 7 because of exhaustion. Primary outcome showed a mean compression depth of 44.1 mm, with an inter-individual standard deviation (SDb) of 13.0 mm and an intra-individual standard deviation (SDw) of 6.7 mm for the control group vs. 46.1 mm and a SDb of 9.0 mm and SDw of 10.3 mm for the intervention group (difference: 1.9; 95% confidence interval -6.9 to 10.8; p = 0.66). Secondary outcomes showed no difference for exhaustion and CPR-quality values. There is no difference in compression depth, quality of CPR, or physical strain on lay rescuers using the initial instruction "push as hard as you can" vs. the standard MPDS(®) instruction "push down firmly 5 cm." Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Study protocol: home-based telehealth stroke care: a randomized trial for veterans

    Directory of Open Access Journals (Sweden)

    McGee-Hernandez Nancy

    2010-06-01

    Full Text Available Abstract Background Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. Methods We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a TR; or (b Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. Discussion For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and

  16. A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study

    Directory of Open Access Journals (Sweden)

    Kanchanaraksa Sukon

    2011-06-01

    Full Text Available Abstract Background Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses. Methods Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline. Results Baseline characteristics were similar in both arms (n = 29 each. Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p Conclusion On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

  17. Day care PNL using 'Santosh-PGI hemostatic seal' versus standard PNL: A randomized controlled study.

    Science.gov (United States)

    Kumar, Santosh; Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

    2016-01-01

    To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission.

  18. Improving psychology students' attitudes toward people with schizophrenia: A quasi-randomized controlled study.

    Science.gov (United States)

    Magliano, Lorenza; Rinaldi, Angela; Costanzo, Regina; De Leo, Renata; Schioppa, Giustina; Petrillo, Miriam; Read, John

    2016-01-01

    Despite scientific evidence that the majority of people with schizophrenia (PWS) have personal histories of traumatic life events and adversities, their needs for psychological support often remain unmet. Poor availability of nonpharmacological therapies in schizophrenia may be partly because of professionals' attitudes toward people diagnosed with this disorder. As future health professionals, psychology students represent a target population for efforts to increase the probability that PWS will be offered effective psychological therapies. This quasi-randomized controlled study investigated the effect of an educational intervention, addressing common prejudices via scientific evidence and prerecorded audio-testimony from PWS, on the attitudes of psychology students toward PWS. Students in their fifth year of a master's degree in Psychology at the Second University of Naples, Italy were randomly assigned to an experimental group-which attended two 3-hr sessions a week apart-or to a control group. Compared with their baseline assessment, at 1-month reassessment the 76 educated students endorsed more psychosocial causes and more of them recommended psychologists in the treatment of schizophrenia. They were also more optimistic about recovery, less convinced that PWS are recognizable and unpredictable, and more convinced that treatments, pharmacological and psychological, are useful. No significant changes were found, from baseline to 1-month reassessment, in the 112 controls. At 1-month reassessment, educated students were more optimistic about recovery and less convinced that PWS are unpredictable than controls. These findings suggest that psychology students' attitudes toward PWS can be improved by training initiatives including education and indirect contact with users. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  19. Bone marrow-derived cells and biophysical stimulation for talar osteochondral lesions: a randomized controlled study.

    Science.gov (United States)

    Cadossi, Matteo; Buda, Roberto Emanuele; Ramponi, Laura; Sambri, Andrea; Natali, Simone; Giannini, Sandro

    2014-10-01

    Osteochondral lesions of the talus (OLT) frequently occur after ankle sprains in young patients participating in sports activities. These injuries may lead to chronic pain, joint swelling, and finally osteoarthritis, therefore, surgical repair is frequently needed. A collagen scaffold seeded with bone marrow-derived cells (BMDCs) harvested from patient's iliac crest and implanted into the OLT through a single arthroscopic procedure has been recently proposed as an effective treatment option. Nevertheless, BMDCs, embedded in an inflammatory environment, tend to differentiate toward a fibroblast phenotype with a consequential loss of mechanical characteristics. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been shown to promote anabolic chondrocyte activity, stimulate proteoglycan synthesis, and reduce the release of the most relevant pro-inflammatory cytokines. The aim of this randomized controlled trial was to evaluate the effects of PEMFs on clinical outcome in patients who underwent BMDCs transplantation for OLT. Thirty patients affected by grade III and IV Outerbridge OLT underwent BMDCs transplantation. After surgery, patients were randomly assigned to either experimental group (PEMFs 4 hours per day for 60 days starting within 3 days after operation) or control group. Clinical outcome was evaluated with (American Orthopaedic Foot and Ankle Society) AOFAS score, Visual Analog Scale (VAS), and Short Form-36 (SF-36). Significantly higher AOFAS score was recorded in the experimental group both at 6 or 12 months follow-up. At 60 days and 6 and 12 months follow-up, significant lower pain was observed in the experimental group. No significant difference was found in SF-36 between groups. A superior clinical outcome was found in the experimental group with more than 10 points higher AOFAS score at final follow-up. Biophysical stimulation started soon after surgery aided patient recovery leading to pain control and a better clinical outcome

  20. Differences in taste between three polyethylene glycol preparations: a randomized double-blind study.

    Science.gov (United States)

    Lam, Tze J; Mulder, Chris Jj; Felt-Bersma, Richelle Jf

    2011-01-01

    Patients suffering from chronic constipation require long-term, regular therapy with laxatives. Literature regarding patient preference and acceptance in polyethylene glycol preparations is scarce. Therefore, this research aimed to identify preference between the three polyethylene glycol 3350, namely Molaxole(®), Movicol(®), and Laxtra Orange(®). Furthermore, taste is one of the most important factors leading to patients' adherence, particularly when the treatment lasts for a long time. In this randomized, cross-over double-blind study, 100 volunteers were recruited by advertisement. The volunteers were invited to taste the preparations and grade the taste using a five-point hedonic scale (extremely poor taste [1] to extremely good taste [5]). The volunteers were then asked to choose the most palatable preparation. One hundred volunteers with a mean age of 35 years (range 20-61) were randomized (76 females). Molaxole(®), Movicol(®), and Laxtra Orange(®) had a mean hedonic score of 2.76 (SD: 0.82), 2.81 (SD: 0.76) and 3.12 (SD: 0.82) respectively. The hedonic taste score for Laxtra Orange(®) was significantly better than Molaxole(®) (P = 0.001) and Movicol(®) (P = 0.001). No difference was found between Molaxole(®) and Movicol(®) (P = 0.61). Molaxole(®) was the most preferred preparation for 19 volunteers (19%), Movicol(®) for 24 volunteers (25%) and Laxtra Orange(®) for 55 volunteers (56%). Two volunteers had no preference. The order in which volunteers tested the preparations had no influence on the taste results. No significant differences in age or gender were observed. Laxtra Orange(®) was most palatable preparation. This may have implications for adherence in patients with chronic constipation.

  1. Elearning approaches to prevent weight gain in young adults: A randomized controlled study.

    Science.gov (United States)

    Nikolaou, Charoula Konstantia; Hankey, Catherine Ruth; Lean, Michael Ernest John

    2015-12-01

    Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media. © 2015 The Obesity Society.

  2. Wean earlier and automatically with new technology (the WEAN study). A multicenter, pilot randomized controlled trial.

    Science.gov (United States)

    Burns, Karen E A; Meade, Maureen O; Lessard, Martin R; Hand, Lori; Zhou, Qi; Keenan, Sean P; Lellouche, Francois

    2013-06-01

    Automated weaning has not been compared with a paper-based weaning protocol in North America. We conducted a pilot randomized trial comparing automated weaning with protocolized weaning in critically ill adults to evaluate clinician compliance and acceptance of the weaning and sedation protocols, recruitment, and impact on outcomes. From August 2007 to October 2009, we enrolled critically ill adults requiring more than 24 hours of mechanical ventilation and at least partial reversal of the condition precipitating respiratory failure at nine Canadian intensive care units. We randomized patients who tolerated at least 30 minutes of pressure support and either failed or were not yet ready to undergo a spontaneous breathing trial to automated or protocolized weaning. Both groups used pressure support, included spontaneous breathing trials, used a common positive end-expiratory pressure-FI(O(2)) chart, sedation protocol, and criteria for extubation, reintubation, and noninvasive ventilation. We recruited 92 patients (49 automated, 43 protocolized) over 26 months. Adherence to assigned weaning protocols and extreme sedation scale scores fell within prespecified thresholds. Combined physician-respiratory therapist and nurse acceptance scores of the study weaning and sedation protocols, respectively, were not significantly different. Automated weaning patients had significantly shorter median times to first successful spontaneous breathing trial (1.0 vs. 4.0 d; P 4.0 d; P = 0.02), and successful extubation (4.0 vs. 5.0 d; P = 0.01), and underwent fewer tracheostomies and episodes of protracted ventilation. Compared with a standardized protocol, automated weaning was associated with promising outcomes that warrant further investigation. Minor protocol modifications may increase compliance, facilitate recruitment, and enhance feasibility. Clinical trial registered with www.controlled-trials.com (ISRCTN43760151).

  3. Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chantepie, Sylvain P; Mear, Jean-Baptiste; Guittet, Lydia; Dervaux, Benoît; Marolleau, Jean-Pierre; Jardin, Fabrice; Dutheil, Jean-Jacques; Parienti, Jean-Jacques; Vilque, Jean-Pierre; Reman, Oumedaly

    2015-11-23

    Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care. The 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade ≥ 3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %. 14-128; Clinicaltrials.gov NCT02461264

  4. Arterial puncture using insulin needle is less painful than with standard needle: a randomized crossover study.

    Science.gov (United States)

    Ibrahim, Irwani; Yau, Ying Wei; Ong, Lizhen; Chan, Yiong Huak; Kuan, Win Sen

    2015-03-01

    Arterial punctures are important procedures performed by emergency physicians in the assessment of ill patients. However, arterial punctures are painful and can create anxiety and needle phobia in patients. The pain score of radial arterial punctures were compared between the insulin needle and the standard 23-gauge hypodermic needle. In a randomized controlled crossover design, healthy volunteers were recruited to undergo bilateral radial arterial punctures. They were assigned to receive either the insulin or the standard needle as the first puncture, using blocked randomization. The primary outcome was the pain score measured on a 100-mm visual analogue scale (VAS) for pain, and secondary outcomes were rate of hemolysis, mean potassium values, and procedural complications immediately and 24 hours postprocedure. Fifty healthy volunteers were included in the study. The mean (±standard deviation) VAS score in punctures with the insulin needle was lower than the standard needle (23 ± 22 mm vs. 39 ± 24 mm; mean difference = -15 mm; 95% confidence interval = -22 mm to -7 mm; p standard needle (31.3% vs. 11.6%, p = 0.035; and 4.6 ±0.7 mmol/L vs. 4.2 ±0.5 mmol/L, p = 0.002). Procedural complications were lower in punctures with the insulin needle both immediately postprocedure (0% vs. 24%; p standard needles. However, due to the higher rate of hemolysis, its use should be limited to conditions that do not require a concurrent potassium value in the same blood sample. © 2015 by the Society for Academic Emergency Medicine.

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

    Directory of Open Access Journals (Sweden)

    Tekur Padmini

    2010-01-01

    Full Text Available 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. The yoga group practiced a specific module for CLBP comprising of asanas (physical postures, pranayama (breathing practices, meditation and lectures on yoga philosophy. The control group practiced physical therapy exercises for back pain. Perceived stress scale (PSS was used to measure baseline stress levels. Outcome measures were WHOQOL Bref for quality of life and straight leg raising test (SLR using a Goniometer. Results: There were significant negative correlations (Pearson′s, P<0.005, r>0.30 between baseline PSS with all four domains and the total score of WHOQOLBref. All the four domains′ WHOQOLBref improved in the yoga group (repeated measures ANOVA P=0.001 with significant groupFNx01time interaction (P<0.05 and differences between groups (P<0.01. SLR increased in both groups (P=0.001 with higher increase in yoga (31.1 % right, 28.4 % left than control (18.7% right, 21.5 % left group with significant groupFNx01time interaction (SLR right leg P=0.044. Conclusion: In CLBP, a negative correlation exists between stress and quality of life. Yoga increases quality of life and spinal flexibility better than physical therapy exercises.

  6. An innovative acupuncture treatment for primary dysmenorrhea: a randomized cross-over pilot study

    Science.gov (United States)

    Wade, Christine M.; Abercrombie, Priscilla D.; Gomolak, Denise

    2013-01-01

    Background/Objective Dysmenorrhea is highly prevalent among adolescent women and a major cause of activity restriction. Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use. Our study objective was to examine feasibility, acceptability, and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women. Methods/Design We conducted a pilot study using a crossover trial design. Women with primary dysmenorrhea were randomized to receive vitamin K1 injection in the Spleen-6 acupuncture point at the start of menstruation followed by saline in a non-acupuncture point after two months, or the reverse order of treatments. Setting/Participants The study was conducted in the San Francisco Bay Area among women 18 and 25 years of age diagnosed with primary dysmenorrhea; fourteen women completed all study visits. Primary Outcome Measure Dysmenorrhea pain intensity was measured using a 0–10 numeric rating scale before and after injections. Results Women had an average 2.5 point decrease in pain after vitamin K1 injection in Spleen-6 (p dysmenorrhea among young women in San Francisco. Pain decreased with both treatments, with a trend toward greater pain reduction for vitamin K1/Spleen-6 injection. This is consistent with outcomes from the Obstetrics & Gynecology Hospital in Shanghai, China, where the protocol was developed. PMID:24445356

  7. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins.

    Science.gov (United States)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). To examine the role that observational studies can play in complementing data from RCTs, we reviewed published studies for statins, a class of drugs that have been widely used to reduce the risk of cardiovascular (CV) events by lowering low-density lipoprotein cholesterol levels. RCTs have consistently demonstrated the benefits of statin treatment in terms of CV risk reduction and have demonstrated that more intensive statin therapy has incremental benefits over less intensive treatment. Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.

  8. A new hydrogel for the conservative treatment of meniscal lesions: a randomized controlled study.

    Science.gov (United States)

    Zorzi, Claudio; Rigotti, Stefano; Screpis, Daniele; Giordan, Nicola; Piovan, Gianluca

    2015-01-01

    this study aimed to investigate the efficacy of intra-articular (IA) administration of a hydrogel formulation obtained from a hyaluronic acid (HA) derivative (HYADD4(®)) in the management of meniscal tears and in meniscal tear repair. fifty subjects with degenerative meniscal tears were enrolled into this single-site, observer-blind, parallel-group study. Clinical evaluations were performed at baseline and after 14, 30 and 60 days. Clinical outcomes included: pain reduction (Visual Analog Scale), improvement of knee functionality (WOMAC questionnaire), reduction in length and depth of the meniscal lesion (MRI-confirmed) and SF-36 questionnaire scores. Local tolerability and safety were also investigated. a significant reduction in VAS pain (p< 0.001) in favor of HYADD4(®) was recorded at day 14 and maintained at all the follow-up assessments. Data on knee functionality were in line with the VAS pain assessment results. A significant reduction in length and depth of the meniscal lesion, assessed using MRI, was found in the HYADD4(®) group compared to the control group (p<0.001). the results of this study may indicate a new treatment option in the conservative management of patients complaining of pain due to meniscal tears. The MRI data suggest that the hydrogel formulation of HA used in this study may also play a role in the healing process of the lesion. Level I, prospective randomized clinical trial.

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

    Directory of Open Access Journals (Sweden)

    Vasanop Vachiramon

    2016-01-01

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

  10. Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

    2018-04-03

    Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex

  11. Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Li, Xinger; Liu, Haiyan; Feng, Huiping; Xian, Zhongren; Chen, Yanhong; Chen, Jianping; Tang, Chunzhi; Lai, Xinsheng; Lan, Xiaoling; Huang, Huanzhen; Yu, Dongdong

    2017-06-28

    Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic. An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA 1c ) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth

  12. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kristensen Peter L

    2011-10-01

    Full Text Available Abstract Background The aim of the School site, Play Spot, Active transport, Club fitness and Environment (SPACE Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday physical activity (PA among 11-15-year-old adolescents. The study is based on a social ecological framework, and is designed to implement organizational and structural changes in the physical environment. Methods/design The SPACE Study used a cluster randomized controlled study design. Twenty-one eligible schools in the Region of Southern Denmark were matched and randomized in seven pairs according to eight matching variables summarized in an audit tool (crow-fly distance from residence to school for 5-6th graders; area household income; area education level; area ethnicity distribution; school district urbanity; condition and characteristics of school outdoor areas; school health policy; and active transport in the local area. Baseline measurements with accelerometers, questionnaires, diaries, and physical fitness tests were obtained in Spring 2010 in 5-6th grade in 7 intervention and 7 control schools, with follow-up measurements to be taken in Spring 2012 in 7-8th grade. The primary outcome measure is objective average daily physical activity and will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary. Other secondary outcome measures will be obtained, such as, overweight, physical fitness, active commuting to/from school and physical activity in recess periods. Discussion A total of 1348 adolescents in 5-6th grade in the Region of Southern Denmark participated at baseline (n = 14 schools. The response rate was high in all type of measurements (72.6-97.4%. There were no significant differences between intervention and control groups at baseline according to selected background variables and outcome measures: gender (p = .54, age (p = .17, BMI (p = .59, waist

  13. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

    Science.gov (United States)

    Haupt, E; Ledermann, H; Köpcke, W

    2005-02-01

    The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

  14. Topics in random walks in random environment

    International Nuclear Information System (INIS)

    Sznitman, A.-S.

    2004-01-01

    Over the last twenty-five years random motions in random media have been intensively investigated and some new general methods and paradigms have by now emerged. Random walks in random environment constitute one of the canonical models of the field. However in dimension bigger than one they are still poorly understood and many of the basic issues remain to this day unresolved. The present series of lectures attempt to give an account of the progresses which have been made over the last few years, especially in the study of multi-dimensional random walks in random environment with ballistic behavior. (author)

  15. A large-scale study of the random variability of a coding sequence: a study on the CFTR gene.

    Science.gov (United States)

    Modiano, Guido; Bombieri, Cristina; Ciminelli, Bianca Maria; Belpinati, Francesca; Giorgi, Silvia; Georges, Marie des; Scotet, Virginie; Pompei, Fiorenza; Ciccacci, Cinzia; Guittard, Caroline; Audrézet, Marie Pierre; Begnini, Angela; Toepfer, Michael; Macek, Milan; Ferec, Claude; Claustres, Mireille; Pignatti, Pier Franco

    2005-02-01

    Coding single nucleotide substitutions (cSNSs) have been studied on hundreds of genes using small samples (n(g) approximately 100-150 genes). In the present investigation, a large random European population sample (average n(g) approximately 1500) was studied for a single gene, the CFTR (Cystic Fibrosis Transmembrane conductance Regulator). The nonsynonymous (NS) substitutions exhibited, in accordance with previous reports, a mean probability of being polymorphic (q > 0.005), much lower than that of the synonymous (S) substitutions, but they showed a similar rate of subpolymorphic (q < 0.005) variability. This indicates that, in autosomal genes that may have harmful recessive alleles (nonduplicated genes with important functions), genetic drift overwhelms selection in the subpolymorphic range of variability, making disadvantageous alleles behave as neutral. These results imply that the majority of the subpolymorphic nonsynonymous alleles of these genes are selectively negative or even pathogenic.

  16. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  17. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  18. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  19. A randomized waitlist control community study of Social Cognition and Interaction Training for people with schizophrenia.

    Science.gov (United States)

    Gordon, Anne; Davis, Penelope J; Patterson, Susan; Pepping, Christopher A; Scott, James G; Salter, Kerri; Connell, Melissa

    2018-03-01

    Social Cognition and Interaction Training (SCIT) has demonstrated effectiveness in improving social cognition and functioning of people with schizophrenia. This pilot study examines the acceptability, feasibility, and effectiveness of SCIT with individuals who have schizophrenia-spectrum disorders and are receiving care through a public mental health service. In a pragmatic randomized waitlist controlled trial, 36 participants (aged 19-55 years) with a schizophrenia spectrum disorder were randomly allocated to SCIT or treatment as usual (TAU). Measures of theory of mind, emotion perception, attributional bias, social skills, quality of life, life skills, depression, anxiety, and stress were administered pre- and post-intervention with follow-up conducted 4 months later. All wait-list controls subsequently received the intervention and a secondary within-group analysis was conducted including these participants. While no significant differences were found between groups on any outcomes, there was strong engagement with the SCIT intervention. Of the 21 participants in the intervention group, the completion rate was 85.71% with a median attendance rate of 17 sessions. Within subject analyses of SCIT participants over time showed significant improvements in quality of life, emotion recognition, social skills, and a trend towards better life skills from pre- to post-intervention. These gains were sustained at the 4-month follow-up time. Although this study showed limited benefits in outcomes associated with SCIT compared with TAU, it demonstrated the acceptability of SCIT to participants in a real world public health setting shown by high retention, attendance, and positive feedback. This pilot shows SCIT can be implemented in routine clinical practice and lays the foundation for a larger pragmatic study. SCIT can be implemented successfully in a real-world community mental health setting. SCIT had high levels of acceptability to these participants. Limitations The

  20. Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study.

    Science.gov (United States)

    Wing, Deborah A; Rumney, Pamela J; Preslicka, Christine W; Chung, Judith H

    2008-10-01

    We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria and symptomatic urinary tract infections. A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times daily (58), B-cranberry at breakfast then placebo at lunch and dinner (67), and C-placebo 3 times daily (63). After 27.7% (52 of 188) of the subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance. There were 27 urinary tract infections in 18 subjects in this cohort, with 6 in 4 group A subjects, 10 in 7 group B subjects and 11 in 7 group C subjects (p = 0.71). There was a 57% and 41% reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections, respectively, in the multiple daily dosing group. However, this study was not sufficiently powered at the alpha 0.05 level (CI 0.14-1.39 and 0.22-1.60, respectively, incidence rate ratios). Of 188 subjects 73 (38.8%) withdrew, most for gastrointestinal upset. These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and symptomatic urinary tract infections in pregnancy. Further studies are planned to evaluate this effect.

  1. Manual therapy in the treatment of ankle hemophilic arthropathy. A randomized pilot study.

    Science.gov (United States)

    Cuesta-Barriuso, Rubén; Gómez-Conesa, Antonia; López-Pina, José-Antonio

    2014-11-01

    Although physiotherapy has demonstrated effectiveness in preventing ankle arthropathy compared to prophylaxis treatment from early ages, there have been no conclusive studies examining physiotherapy intervention once hemophilic arthropathy of the ankle has been established. The aim of this study was to evaluate the effectiveness of two physiotherapy interventions, in patients with hemophilic arthropathy of the ankle that had not been operated on previously. Nine patients with hemophilia (mean age of 35.7 SD 11.9 years) were randomized to a mobilization group (n = 5) and manual therapy group (n = 4). The two physiotherapy interventions were: (1) passive mobilization and stretching; and (2) manual orthopaedic therapy, both with proprioception training. The study lasted for six weeks, with two sessions a week. Ankle mobility and pain perception, lower limb proprioception and quality of life were the outcome measures. Both treatments improved all ankle movements (p ankle arthropathy. No haemarthrosis was recorded during treatment or during the follow-up period.

  2. Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

    Science.gov (United States)

    Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

    2016-08-01

    When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

  3. Treadmill training improves overground walking economy in Parkinson’s disease: A randomized, controlled pilot study

    Directory of Open Access Journals (Sweden)

    Miguel eFERNANDEZ-DEL-OLMO

    2014-09-01

    Full Text Available Gait disturbances are one of the principal and most incapacitating symptoms of Parkinson’s disease (PD. In addition, walking economy is impaired in PD patients and could contribute to excess fatigue in this population. An important number of studies have shown that treadmill training can improve kinematic parameters in PD patients. However, the effects of treadmill and overground walking on the walking economy remain unknown. The goal of this study was to explore the walking economy changes in response to a treadmill and an overground training program, as well as the differences in the walking economy during treadmill and overground walking. 22 mild PD patients were randomly assigned to a treadmill or overground training group. The training program consisted of 5 weeks (3 sessions/week. We evaluated the energy expenditure of overground walking, before and after each of the training programs. The energy expenditure of treadmill walking (before the program was also evaluated. The treadmill, but not the overground training program, lead to an improvement in the walking economy (the rate of oxygen consumed per distance, during overground walking at a preferred speed in PD patients. In addition, walking on a treadmill required more energy expenditure compared with overground walking at the same speed. This study provides evidence that in mild PD patients, treadmill training is more beneficial compared with that of walking overground, leading to a greater improvement in the walking economy. This finding is of clinical importance for the therapeutic administration of exercise in Parkinson’s disease.

  4. Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

    Science.gov (United States)

    Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

    2014-04-01

    This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

  5. Best (but oft-forgotten) practices: the design, analysis, and interpretation of Mendelian randomization studies1

    Science.gov (United States)

    Bowden, Jack; Relton, Caroline; Davey Smith, George

    2016-01-01

    Mendelian randomization (MR) is an increasingly important tool for appraising causality in observational epidemiology. The technique exploits the principle that genotypes are not generally susceptible to reverse causation bias and confounding, reflecting their fixed nature and Mendel’s first and second laws of inheritance. The approach is, however, subject to important limitations and assumptions that, if unaddressed or compounded by poor study design, can lead to erroneous conclusions. Nevertheless, the advent of 2-sample approaches (in which exposure and outcome are measured in separate samples) and the increasing availability of open-access data from large consortia of genome-wide association studies and population biobanks mean that the approach is likely to become routine practice in evidence synthesis and causal inference research. In this article we provide an overview of the design, analysis, and interpretation of MR studies, with a special emphasis on assumptions and limitations. We also consider different analytic strategies for strengthening causal inference. Although impossible to prove causality with any single approach, MR is a highly cost-effective strategy for prioritizing intervention targets for disease prevention and for strengthening the evidence base for public health policy. PMID:26961927

  6. Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study.

    Science.gov (United States)

    Garcia-Palacios, A; Herrero, R; Belmonte, M A; Castilla, D; Guixeres, J; Molinari, G; Baños, R M

    2014-07-01

    Daily diaries are a useful way of measuring fluctuations in pain-related symptoms. However, traditional diaries do not assure the gathering of data in real time, not solving the problem of retrospective assessment. Ecological momentary assessment (EMA) by means of electronic diaries helps to improve repeated assessment. However, it is important to test its feasibility in specific populations in order to reach a wider number of people who could benefit from these procedures. The present study compares the compliance and acceptability of an electronic diary running on a smartphone using a crossover design for a sample with a specific pain condition, fibromyalgia and low familiarity with technology. Forty-seven participants were randomly assigned to one of two conditions: (1) paper diary - smartphone diary and (2) smartphone diary - paper diary, using each assessment method for 1 week. The findings of this study showed that the smartphone diary made it possible to gather more accurate and complete ratings. Besides, this method was well accepted by a sample of patients with fibromyalgia referred by a public hospital, with an important proportion of participants with low level of education and low familiarity with technology. The findings of this study support the use of smartphones for EMA even in specific populations with a specific pain condition, fibromyalgia and with low familiarity with technology. These methods could help clinicians and researchers to gather more accurate ratings of relevant pain-related variables even in populations with low familiarity with technology.

  7. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

    Science.gov (United States)

    Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

    2014-08-01

    The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    Pappalardo, Sabrina; Guarnieri, Renzo

    2014-07-01

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

  9. Testing the Causal Direction of Mediation Effects in Randomized Intervention Studies.

    Science.gov (United States)

    Wiedermann, Wolfgang; Li, Xintong; von Eye, Alexander

    2018-05-21

    In a recent update of the standards for evidence in research on prevention interventions, the Society of Prevention Research emphasizes the importance of evaluating and testing the causal mechanism through which an intervention is expected to have an effect on an outcome. Mediation analysis is commonly applied to study such causal processes. However, these analytic tools are limited in their potential to fully understand the role of theorized mediators. For example, in a design where the treatment x is randomized and the mediator (m) and the outcome (y) are measured cross-sectionally, the causal direction of the hypothesized mediator-outcome relation is not uniquely identified. That is, both mediation models, x → m → y or x → y → m, may be plausible candidates to describe the underlying intervention theory. As a third explanation, unobserved confounders can still be responsible for the mediator-outcome association. The present study introduces principles of direction dependence which can be used to empirically evaluate these competing explanatory theories. We show that, under certain conditions, third higher moments of variables (i.e., skewness and co-skewness) can be used to uniquely identify the direction of a mediator-outcome relation. Significance procedures compatible with direction dependence are introduced and results of a simulation study are reported that demonstrate the performance of the tests. An empirical example is given for illustrative purposes and a software implementation of the proposed method is provided in SPSS.

  10. Needling versus liquid nitrogen cryotherapy for the treatment of pedal warts a randomized controlled pilot study.

    Science.gov (United States)

    Cunningham, Daniel J; Brimage, Jessica T; Naraghi, Reza N; Bower, Virginia M

    2014-07-01

    We hypothesized that needling of a pedal wart creates local inflammation and a subsequent cell-mediated immune response (CMIR) against human papillomavirus. The primary objective of this study was to investigate whether needling to induce a CMIR against human papillomavirus is an effective treatment for pedal warts compared with liquid nitrogen cryotherapy. A secondary objective was to investigate whether the CMIR induced by needling is effective against satellite pedal warts. Eligible patients with pedal warts were randomly allocated to receive either needling or liquid nitrogen cryotherapy. Only the primary pedal wart was treated during the study. Follow-up was 12 weeks, with outcome assessments made independently under blinded circumstances. Of 37 patients enrolled in the study, 18 were allocated to receive needling and 19 to receive liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% of the needling group (11 of 17) and in 6.2% of the liquid nitrogen cryotherapy group (1 of 16) (P =  .001). No significant relationship was found between needling of the primary pedal wart and regression of satellite pedal warts (P = .615) or complete pedal wart regression (P = .175). There was no significant difference in pain, satisfaction, or cosmesis between the two groups. The regression rate of the primary pedal wart was significantly higher in the needling group compared with the liquid nitrogen cryotherapy group.

  11. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  12. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

    Directory of Open Access Journals (Sweden)

    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  13. Coffee, caffeine, and sleep: A systematic review of epidemiological studies and randomized controlled trials.

    Science.gov (United States)

    Clark, Ian; Landolt, Hans Peter

    2017-02-01

    Caffeine is the most widely consumed psychoactive substance in the world. It is readily available in coffee and other foods and beverages, and is used to mitigate sleepiness, enhance performance, and treat apnea in premature infants. This review systematically explores evidence from epidemiological studies and randomized controlled trials as to whether coffee and caffeine have deleterious effects on sleep. Caffeine typically prolonged sleep latency, reduced total sleep time and sleep efficiency, and worsened perceived sleep quality. Slow-wave sleep and electroencephalographic (EEG) slow-wave activity were typically reduced, whereas stage-1, wakefulness, and arousals were increased. Dose- and timing-response relationships were established. The sleep of older adults may be more sensitive to caffeine compared to younger adults. Pronounced individual differences are also present in young people, and genetic studies isolated functional polymorphisms of genes implicated in adenosine neurotransmission and metabolism contributing to individual sensitivity to sleep disruption by caffeine. Most studies were conducted in male adults of Western countries, which limits the generalizability of the findings. Given the importance of good sleep for general health and functioning, longitudinal investigations aimed at establishing possible causal relationships among coffee- and caffeine-induced changes in sleep quality and health development are warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Transabdominal amnioinfusion for preterm premature rupture of membranes: a systematic review and metaanalysis of randomized and observational studies.

    Science.gov (United States)

    Porat, Shay; Amsalem, Hagai; Shah, Prakesh S; Murphy, Kellie E

    2012-11-01

    The purpose of this study was to review systematically the efficacy of transabdominal amnioinfusion (TA) in early preterm premature rupture of membranes (PPROM). We conducted a literature search of EMBASE, MEDLINE, and ClinicalTrials.gov databases and identified studies in which TA was used in cases of proven PPROM and oligohydramnios. Risk of bias was assessed for observational studies and randomized controlled trials. Primary outcomes were latency period and perinatal mortality rates. Four observational studies (n = 147) and 3 randomized controlled trials (n = 165) were eligible. Pooled latency period was 14.4 (range, 8.2-20.6) and 11.41 (range -3.4 to 26.2) days longer in the TA group in the observational and the randomized controlled trials, respectively. Perinatal mortality rates were reduced among the treatment groups in both the observational studies (odds ratio, 0.12; 95% confidence interval, 0.02-0.61) and the randomized controlled trials (odds ratio, 0.33; 95% confidence interval, 0.10-1.12). Serial TA for early PPROM may improve early PPROM-associated morbidity and mortality rates. Additional adequately powered randomized control trials are needed. Copyright © 2012 Mosby, Inc. All rights reserved.

  15. A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

    Science.gov (United States)

    Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

    2016-03-01

    Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  17. Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pérez-Mármol, Jose Manuel; García-Ríos, M Carmen; Barrero-Hernandez, Francisco J; Molina-Torres, Guadalupe; Brown, Ted; Aguilar-Ferrándiz, María Encarnación

    2015-11-05

    Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities. This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38). This trial is

  18. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  19. Effects of Herbal vigRX on Premature Ejaculation: A randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Z Ghafuri

    2010-05-01

    Full Text Available Objective :   "nWe conducted a double-blind, placebo-controlled study todetermine the efficacy of an herbal sexual supplement (vigRX on premature ejaculation (PE. Method: "nA randomized double blind study was conducted on a fixed dose of herbal vigRX at Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample consisted of 85 married patients diagnosed withprimary PE according to Diagnostic and Statistical Manual of Mental Disorders. Each patient underwent diagnostic evaluation by one trained psychiatrist, using Structured Clinical Interview for DSM-IV-TR. Each patient was evaluated by researchers to exclude the organic sexual dysfunctions. The patients were randomly assigned in to two groups: group 1 consisting of 42 patients receiving placebo, and group 2 consisting of 43 patients receiving 540 mg herbal vigRX for a 4-week treatment course. The effects of the drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of the treatment course. Statistical analysis was performed using SPSS software (15th version.      Results: "nThe mean IELT increased 22.4 and 32.0 seconds in the placebo and the vigRX group respectively after the treatment course. The mean IELT differences between the two groups was not significant. The mean CIPE score increased 2.40 and 4.37 in the placebo and the vigRX group respectively .The mean CIPE score differences between the two groups was not significant.No side effect was reported by the subjects in neither groups during the treatment course. "nConclusion: Although the improvement in IELT and CIPE scores in the herbal vigRX group was more than the placebo group, this difference was not statistically significant. The increasing of IELT and CIPE score in the placebo group may be due to the placebo effects. Further studies with higher vigRX doses, greater sample size

  20. A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

    Science.gov (United States)

    Kraft, Stephanie A; Constantine, Melissa; Magnus, David; Porter, Kathryn M; Lee, Sandra Soo-Jin; Green, Michael; Kass, Nancy E; Wilfond, Benjamin S; Cho, Mildred K

    2017-02-01

    Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p informational aids with a character-driven story component (animated videos and comics) and those without. Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can

  1. Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Mikyung; Kim, Jung-Eun; Lee, Hye-Yoon; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Kim, Eun-Jung; Park, Yeon-Cheol; Seo, Byung-Kwan; Cho, Jung Hyo; Kim, Joo-Hee

    2017-07-05

    Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue. A multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life

  2. A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol.

    Science.gov (United States)

    Ogedegbe, Gbenga; Plange-Rhule, Jacob; Gyamfi, Joyce; Chaplin, William; Ntim, Michael; Apusiga, Kingsley; Khurshid, Kiran; Cooper, Richard

    2014-06-12

    Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction. Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140-179/90-99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as

  3. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

  4. Immunomodulatory effects of ResistAid™: A randomized, double-blind, placebo-controlled, multidose study.

    Science.gov (United States)

    Udani, Jay K

    2013-01-01

    To evaluate the ability of a proprietary arabinogalactan extract from the larch tree (ResistAid, Lonza Ltd., Basel, Switzerland) to change the immune response in healthy adults to a standardized antigenic challenge (tetanus and influenza vaccines) in a dose-dependent manner compared to placebo. This randomized, double-blind, placebo-controlled trial included 75 healthy adults (18-61 years old). Subjects were randomized to receive either 1.5 or 4.5 g/day of ResistAid or placebo for 60 days. At day 30, subjects were administered both tetanus and influenza vaccines. Serum antigenic response (tetanus immunoglobulin G [IgG], influenza A and B IgG and immunoglobulin M [IgM]) was measured at days 45 (15 days after vaccination) and 60 (30 days after vaccination) of the study and compared to baseline antibody levels. Frequency and intensity of adverse events were monitored throughout the study. As expected, all 3 groups demonstrated an expected rise in tetanus IgG levels 15 and 30 days following the vaccine. There was a strongly significant difference in the rise in IgG levels at day 60 in the 1.5 g/day group compared to placebo (p = 0.008). In the 4.5 g/day group, there was significant rise in tetanus IgG at days 45 and 60 compared to baseline (p < 0.01) but these values were not significant compared to placebo. Neither group demonstrated any significant elevations in IgM or IgG antibodies compared to placebo following the influenza vaccine. There were no clinically or statistically significant or serious adverse events. ResistAid at a dose of 1.5 g/day significantly increased the IgG antibody response to tetanus vaccine compared to placebo. In conjunction with earlier studies, this validates the effect of ResistAid on the augmentation of the response to bacterial antigens (in the form of vaccine).

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

    Science.gov (United States)

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

    2014-07-01

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

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

    Science.gov (United States)

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

    2014-07-01

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

  7. Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

    Science.gov (United States)

    Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

    2018-01-01

    The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study

    DEFF Research Database (Denmark)

    Heller, Simon; Damm, Peter; Mersebach, Henriette

    2010-01-01

    OBJECTIVE A recent randomized trial compared prandial insulin aspart (IAsp) with human insulin in type 1 diabetic pregnancy. The aim of this exploratory analysis was to investigate the incidence of severe hypoglycemia during pregnancy and compare women enrolled preconception with women enrolled...... during early pregnancy. RESEARCH DESIGN AND METHODS IAsp administered immediately before each meal was compared with human insulin administered 30 min before each meal in 99 subjects (44 to IAsp and 55 to human insulin) randomly assigned preconception and in 223 subjects (113 for IAsp and 110 for human...... insulin) randomly assigned in early pregnancy (...

  9. Exercise on prescription: a randomized study on the effect of counseling vs counseling and supervised exercise

    DEFF Research Database (Denmark)

    Kragstrup, J.; Skovgaard, T.; Puggaard, L.

    2008-01-01

    (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......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...

  10. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication.

    Science.gov (United States)

    Momsen, A H; Jensen, M B; Norager, C B; Madsen, M R; Vestersgaard-Andersen, T; Lindholt, J S

    2010-10-01

    Intermittent claudication is a disabling symptom of peripheral arterial disease for which few medical treatments are available. This study investigated the effect of caffeine on physical capacity in patients with intermittent claudication. This randomized double-blind placebo-controlled crossover study included 88 patients recruited by surgeons from outpatient clinics. The participants abstained from caffeine for 48 h before each test and then received either a placebo or oral caffeine (6 mg/kg). After 75 min, pain-free and maximal walking distance on a treadmill, perceived pain, reaction times, postural stability, maximal isometric knee extension strength, submaximal knee extension endurance and cognitive function were measured. The analysis was by intention to treat. Caffeine increased the pain-free walking distance by 20.0 (95 per cent confidence interval 3.7 to 38.8) per cent (P = 0.014), maximal walking distance by 26.6 (12.1 to 43.0) per cent (P postural stability was reduced significantly, by 22.1 (11.7 to 33.4) per cent with eyes open (P < 0.001) and by 21.8 (7.6 to 37.8) per cent with eyes closed (P = 0.002). Neither reaction time nor cognition was affected. In patients with moderate intermittent claudication, caffeine increased walking distance, maximal strength and endurance, but affected balance adversely.

  11. Percutaneous CT-guided lung biopsy: sequential versus spiral scanning. A randomized prospective study

    International Nuclear Information System (INIS)

    Ghaye, B.; Dondelinger, R.F.; Dewe, W.

    1999-01-01

    The aim of this study was to evaluate in a prospective and randomized study spiral versus sequential scanning in the guidance of percutaneous lung biopsy. Fifty thoracic lesions occurring in 48 patients were biopsied by a senior and a junior operator. Six different time segments of the procedure were measured. Scanning mode versus length of procedure, pathological results, irradiation and complications were evaluated. Total duration of the procedure and of the first sampling was significantly longer with spiral CT for the senior operator (p < 0.004). No significant time difference was observed for the junior operator. Diameter of the lesion, depth of location, position of the patient and needle entry site did not influence the results. The sensitivity was 90.9, specificity 100, positive predictive value 100 and negative predictive value 60 % for spiral CT, and 94.7, 100, 100 and 85.7 % for sequential CT, respectively. Eleven pneumothoraces and ten perinodular hemorrhages were seen with spiral CT and six and ten, respectively, with sequential CT. The mean dose of irradiation was 4027 mAs for spiral CT and 2358 mAs for conventional CT. Spiral CT does neither reduce procedure time nor the rate of complications. Pathological results do not differ compared with sequential CT, and total dose of irradiation is higher with spiral scanning. (orig.)

  12. The Effectiveness of School-Based Nutritional Education Program among Obese Adolescents: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Supinya In-Iw

    2012-01-01

    Full Text Available The purpose of the study was to determine the change in body weight and body mass index (BMI, as well as diet behaviors at 4 months after intervention between obese adolescent girls who participated in the school-based nutritional education program, addressed by pediatrician, compared to those who attended regular nutritional class. Methods. 49 obese girls were recruited from a secondary school. Those, were randomized into 2 groups of intervention and control. The intensive interactive nutritional program was provided to the intervention group. Weight and height, dietary record and % fat consumption, as well as self-administered questionnaires on healthy diet attitudes were collected at baseline and 4-month follow-up, and then compared between two groups. Results. There was a statistically significant change of BMI in the intervention group by  kg/m2 ( compared to the control group ( kg/m2, but no significant change in calorie and % fat consumption between groups. The attitudes on healthy eating behaviors in the intervention group were shown improving significantly (. Conclusions. Interactive and intensive nutritional education program as shown in the study was one of the most successful school-based interventions for obese adolescents.

  13. Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

    Science.gov (United States)

    Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

    2011-01-01

    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

  14. Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study.

    Science.gov (United States)

    Gribetz, Carin; Ling, Mark; Lebwohl, Mark; Pariser, David; Draelos, Zoe; Gottlieb, Alice B; Zaias, Nardo; Chen, Diana M; Parneix-Spake, Anne; Hultsch, Thomas; Menter, Alan

    2004-11-01

    Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.

  15. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study.

    Science.gov (United States)

    Brueckmann, B; Sasaki, N; Grobara, P; Li, M K; Woo, T; de Bie, J; Maktabi, M; Lee, J; Kwo, J; Pino, R; Sabouri, A S; McGovern, F; Staehr-Rye, A K; Eikermann, M

    2015-11-01

    This study aimed to investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness. Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade. Timing of reversal agent administration was based on the providers' clinical judgement. Primary endpoint was the presence of residual neuromuscular blockade at PACU admission, defined as a train-of-four (TOF) ratio sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission (odds ratio 0.0, 95% CI [0-0.06], Psugammadex vs usual care (14.7 vs. 18.6 min respectively; P=0.02). After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU, and shortened the time from start of study medication administration to the time the patient was ready for discharge from the operating room. Clinicaltrials.gov:NCT01479764. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Effect of Sugammadex on Postoperative Bleeding and Coagulation Parameters After Septoplasty: A Randomized Prospective Study

    Science.gov (United States)

    Taş, Nilay; Korkmaz, Hakan; Yağan, Özgür; Korkmaz, Mukadder

    2015-01-01

    Backround Sugammadex is a reversal agent with well known advantages but it’s effects on haemostasis and bleeding have bee