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

Science.gov (United States)

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.

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.

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.

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].

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.

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 ...

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%)

Hysterography and hysteroscopy. A comparative study with 50 patients

Energy Technology Data Exchange (ETDEWEB)

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.

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

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Devleta Balić

2011-05-01

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

The role of hysteroscopy in diagnosis and treatment of postmenopausal bleeding

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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

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.

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

[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

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)

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

Directory of Open Access Journals (Sweden)

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

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

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Ahmed Reda

2016-01-01

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

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.

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....

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

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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.

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.

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.

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.

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

Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB

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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

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.

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.

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

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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.

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.

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

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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.

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

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

Evaluation of pain in outpatient diagnostic hysteroscopy with gas

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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.

The Role of Hysteroscopy in the Diagnosis and Treatment of Adenomyosis

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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.

ROLE OF HYSTEROSCOPY IN THE MANAGEMENT OF SECONDARY POSTPARTUM HAEMORRHAGE

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Krupa Patalay

2016-03-01

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

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

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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.

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.

Preoperative ripening of the cervix before operative hysteroscopy.

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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

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

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Salete Yatabe

2011-12-01

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

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.

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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.

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

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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

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.

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

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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

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

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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.

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

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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...

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

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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.

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

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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.

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

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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.

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

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K Shojaie

2009-10-01

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

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

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Yasser I. Abd Elkhalek

2016-09-01

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

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

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J.C. Paredes Palma

2016-10-01

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

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.

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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.

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

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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.

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

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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

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

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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

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

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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.

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

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

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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

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

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

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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.

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

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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.

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

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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.

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.

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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.

A comparison of hysteroscopic mechanical tissue removal with bipolar electrical resection for the management of endometrial polyps in an ambulatory care setting: preliminary results.

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Pampalona, Jennifer Rovira; Bastos, Maria Degollada; Moreno, Gemma Mancebo; Pust, Andrea Buron; Montesdeoca, Gemma Escribano; Guerra Garcia, Angel; Pruñonosa, Juan Carles Mateu; Collado, Ramon Carreras; Torras, Pere Bresco

2015-01-01

To assess and compare efficacy, pain, and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting. A randomized controlled clinical trial (Canadian Task Force classification I). Hospital de Igulada, Barcelona, Spain. A total of 133 patients diagnosed with endometrial polyp(s) were included and randomly assigned to 1 of the 2 hysteroscopic methods. Criteria assessed were total hysteroscopy time, full polypectomy procedure time, pain experienced by patients, and learning curve of staff in training. The average time to perform total hysteroscopy using the mechanical tissue removal system (TRUCLEAR 5.0 System; Smith & Nephew Inc., Andover, MD) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system (GYNECARE VERSAPOINT; Ethicon Inc, Somerville, NJ) (p .05). A study of the residents' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System. In hysteroscopic polypectomy, the mechanical tissue removal system was significantly faster, achieved a greater success rate for complete polypectomy, and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

[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].

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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

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...

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

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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.

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.

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

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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.

Comparison between local anaesthesia with remifentanil and total intravenous anaesthesia for operative hysteroscopic procedures in day surgery

DEFF Research Database (Denmark)

Majholm, B; Bartholdy, J; Clausen, H V

2012-01-01

BACKGROUND: /st>This study aimed at comparing total i.v. anaesthesia (TIVA) with monitored anaesthesia care (MAC) during day-surgery operative hysteroscopy regarding: operation time, time to mobilization and discharge, and patient satisfaction. METHODS: /st>Ninety-one healthy women were randomized...... to MAC with paracervical local anaesthesia and remifentanil or to TIVA with propofol and remifentanil. Time from arrival to leaving the operating theatre, time from arrival in the recovery room to mobilization and discharge readiness, and patient satisfaction with MAC and TIVA were observed. RESULTS: /st.......003). CONCLUSIONS: /st>Paracervical local anaesthesia combined with remifentanil is suitable for operative hysteroscopy in day surgery....

HYSTEROSCOPIC EVALUATION OF WOMEN IN REPRODUCTIVE AGE GROUP WITH ABNORMAL UTERINE BLEEDING

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E. Vanaja Reddy

2016-10-01

Full Text Available BACKGROUND Abnormal uterine bleeding is the most common complaint in gynaecology and an important source of morbidity. This study evaluates the usefulness of hysteroscopy in the diagnosis of abnormal uterine bleeding in comparison to dilatation and curettage in reproductive age group. MATERIALS AND METHODS Between September 2011 to July 2013, women with AUB attending Gynaec OP were subjected to hysteroscopy and subsequent dilatation and curettage. Data was collected and analysed. RESULTS AUB was more common in 30-34 yrs. The most common presenting complaint was menorrhagia. Normal hysteroscopic view was seen in 50% cases. Abnormalities seen were endometrial hyperplasia, polyps, submucous myoma synechiae and rue. Both hysteroscopy and curettage gave specificity of 70%, but the ability to diagnose focal lesion (sensitivity was more with hysteroscopy in comparison to curettage 70 vis. 36. 43 patients had the same tissue diagnosis in both hysteroscopy and curettage. Hysteroscopy revealed more information than curettage in 42% and curettage had more information in 15% cases, 100% accuracy was seen in case of myoma, IUCD, adhesions and polyps with hysteroscopy. CONCLUSION This study confirms the conclusion of many others that hysteroscopy is superior to dilatation and curettage in evaluating patients with abnormal uterine bleeding.

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.

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.

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

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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

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

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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

Imaging for Polyps and Leiomyomas in Women With Abnormal Uterine Bleeding: A Systematic Review.

Science.gov (United States)

Maheux-Lacroix, Sarah; Li, Fiona; Laberge, Philippe Y; Abbott, Jason

2016-12-01

To evaluate the accuracy of saline infusion sonohysterography in comparison with transvaginal ultrasonography for diagnosing polyps and submucosal leiomyomas in women with abnormal uterine bleeding. We searched the databases MEDLINE, EMBASE, CENTRAL, and ClinicalTrials.gov as well as citations and reference lists to the end of November 2015. Two authors screened 5,347 citations for eligibility. We included randomized controlled trials or prospective cohort studies published in English, assessing the accuracy of saline infusion sonohysterography and transvaginal ultrasonography for diagnosing polyps and submucosal leiomyomas in women with abnormal uterine bleeding. We considered studies using histopathologic specimens obtained at either hysteroscopy or hysterectomy as criterion standard. Twenty-five studies were eligible. Two authors extracted data and assessed the quality of included studies. Bivariate random-effects models were used to compare the different tests and evaluate sources of heterogeneity. Saline infusion sonohysterography was superior to transvaginal ultrasonography with pooled sensitivity and specificity of 0.92 and 0.89 compared with 0.64 and 0.90, respectively (Pabnormal uterine bleeding. Although less specific than hysteroscopy, saline infusion sonohysterography offers a similar detection rate and permits concomitant visualization of the ovaries and myometrium. Cost, convenience, and tolerability of different imaging techniques require further evaluation. PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO, CRD42016034005.

What is the use of hysterocopy in menopause?

Directory of Open Access Journals (Sweden)

Álvaro Monterrosa Castro

2007-05-01

Full Text Available In the last years, hysteroscopy has evolved from the diagnostic pointof view to the therapeutic, being taken from the operating room tothe doctor’s office. Hysteroscopy allows, with a higher precision, the definition of the etiologic diagnosis of a very important sign in the mature woman, which is the abnormal uterine bleeding. A womanin postmenopausal age who takes or not hormonal therapy shouldbe examined with the help of the hysteroscopy in some circumstances focusing on that it is not a study for daily use.

Download this PDF file

African Journals Online (AJOL)

Mr Olusoji

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

Intracavitary deposits on Essure® hysteroscopic sterilization devices : A case report

OpenAIRE

Maassen, L. W.; van Gastel, Maatje D A; Lentjes, E. G.W.M.; Bongers, M. Y.; Veersema, S.

2017-01-01

Objective: To study the composition of intracavitary deposits on Essure® hysteroscopic sterilization devices. Design: Case report. Setting: Reproductive Medicine and Gynecology department of a University Hospital. Patient(s): A 39 years old patient presenting with a request for surgical removal of Essure® sterilization devices. Diagnostic hysteroscopy showed a crystal like white deposit attached to one of the devices. Intervention: Diagnostic hysteroscopy and surgical removal of E...

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.

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.

Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis.

Science.gov (United States)

Potdar, Neelam; Gelbaya, Tarek; Nardo, Luciano G

2012-12-01

Mechanical endometrial injury (biopsy/scratch or hysteroscopy) in the cycle preceding ovarian stimulation for IVF has been proposed to improve implantation in women with unexplained recurrent implantation failure (RIF). This is a systematic review and meta-analysis of studies comparing the efficacy of endometrial injury versus no intervention in women with RIF undergoing IVF. All controlled studies of endometrial biopsy/scratch or hysteroscopy performed in the cycle preceding ovarian stimulation were included and the primary outcome measure was clinical pregnancy rate. Pooling of seven controlled studies (four randomized and three non-randomized), with 2062 participants, showed that local endometrial injury induced in the cycle preceding ovarian stimulation is 70% more likely to result in a clinical pregnancy as opposed to no intervention. There was no statistically significant heterogeneity in the methods used, clinical pregnancy rates being twice as high with biopsy/scratch (RR 2.32, 95% CI 1.72-3.13) as opposed to hysteroscopy (RR 1.51, 95% CI 1.30-1.75). The evidence is strongly in favour of inducing local endometrial injury in the preceding cycle of ovarian stimulation to improve pregnancy outcomes in women with unexplained RIF. However, large randomized studies are required before iatrogenic induction of local endometrial injury can be warranted in routine clinical practice. Some women undergoing IVF treatment fail to conceive despite several attempts with good-quality embryos and no identifiable reason. We call this 'recurrent implantation failure' (RIF) where the embryo fails to embed or implant within the lining of the womb. Studies have shown that inducing injury to the lining of the womb in the cycle before starting ovarian stimulation for IVF can help improve the chances of achieving pregnancy. Injury can be induced by either scratching the lining of the womb using a biopsy tube or by telescopic investigation of the womb using a camera. We performed a

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.

Role of diagnostic hystero-laparoscopy in the evaluation of infertility: A retrospective study of 300 patients

Directory of Open Access Journals (Sweden)

Prasanta K Nayak

2013-01-01

Full Text Available Objective: To determine the role of diagnostic hysterolaparoscopy in the evaluation of infertility in tertiary care centres. Materials and Methods: This retrospective study was conducted at two tertiary care centres (the infertility clinics of Sriram Chandra Bhanj Medical College and Prachi hospital at Cuttack, Odisha throughout the year in 2008. Women aged 20-40 years with normal hormone profile without male factor infertility were included. Results: Out of 300 cases, 206 (69% patients had primary infertility. While laparoscopy detected abnormalities in 34% of the cases, significant hysteroscopy findings were noted in 18% of cases. Together, diagnostic hysterolaparoscopy detected abnormalities in 26% of the infertile patients in both groups. While the most common laparoscopic abnormality was endometriosis (14% and adnexal adhesion (12% in primary and secondary infertile patients, respectively, hysteroscopy found intrauterine septum as the most common abnormality in both groups. Conclusions: Hysterolaparoscopy is an effective diagnostic tool for evaluation of certain significant and correctable tubo-peritoneal and intrauterine pathologies like peritoneal endometriosis, adnexal adhesions, and subseptate uterus, which are usually missed by other imaging modalities.

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.

Office hysteroscopic-guided selective tubal chromopertubation: acceptability, feasibility and diagnostic accuracy of this new diagnostic non-invasive technique in infertile women.

Science.gov (United States)

Carta, Gaspare; Palermo, Patrizia; Pasquale, Chiara; Conte, Valeria; Pulcinella, Ruggero; Necozione, Stefano; Cofini, Vincenza; Patacchiola, Felice

2018-06-01

The aim of this study was to evaluate accuracy, tolerability and side effects of office hysteroscopic-guided chromoperturbations in infertile women without anaesthesia. Forty-nine infertile women underwent the procedure to evaluate tubal patency and the uterine cavity. Women with unilateral or bilateral tubal stenosis at hysteroscopy with chromoperturbation, and women with bilateral tubal patency who did not conceive during the period of six months, underwent laparoscopy with chromoperturbation. The results obtained from hysteroscopy and laparoscopy in the assessment of tubal patency were compared. Sensitivity, specificity, accuracy, positive-predictive value and negative-predictive value were used to describe diagnostic performance. Pain and tolerance were assessed during procedure using a visual analogue scale (VAS). Side effects or late complications and pregnancy rate were also recorded three and six months after the procedure. The specificity was 87.8% (95% CI: 73.80-95.90), sensitivity was 85.7% (95% CI 57.20-98.20), positive and negative predictive values were 70.6% (95% CI: 44.00-89) and 94.7% (95% CI: 82.30-99.40), respectively. Pregnancy rate (PR) within six months after performance of hysteroscopy with chromoperturbation was 27%. Office hysteroscopy-guided selective chromoperturbation in infertile patients is a valid technique to evaluate tubal patency and uterine cavity.

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

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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.

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.

A new hysteroscopic technique for the preparation of partially intramural myomas in office setting (OPPIuM technique): A pilot study.

Science.gov (United States)

Bettocchi, Stefano; Di Spiezio Sardo, Attilio; Ceci, Oronzo; Nappi, Luigi; Guida, Maurizio; Greco, Elena; Pinto, Lauro; Camporiale, Anna Lina; Nappi, Carmine

2009-01-01

To assess the safety and the effectiveness of a novel hysteroscopic technique for the Office Preparation of Partially Intramural Myomas (OPPIuM), to facilitate the subsequent, already scheduled, resectoscopic myomectomy. Pilot study. University of Bari, Naples and Foggia. Fifty-nine fertile women (age 27-48 years) diagnosed at office hysteroscopy as having symptomatic submucous myomas>1.5 cm with intramural development (G1 and G2), scheduled for resectoscopic surgery. The OPPIuM technique consisted of an incision of the endometrial mucosa covering the myoma by means of Fr scissors or bipolar Versapoint Twizzle electrode, along its reflection line on the uterine wall, up to the precise identification of the cleavage surface between the myoma and its pseudo-capsule. Such procedure was aimed at triggering the protrusion of the intramural portion of the myoma into the uterine cavity during the following menstrual cycles, thus facilitating the subsequent total removal of the lesion via resectoscopic surgery. All patients underwent follow-up in-patient hysteroscopy after 2 menstrual cycles before resectoscopic surgery were performed. The OPPIuM technique was successfully performed in all cases. The mean diameter of successfully prepared myomas was 2.9+/-0.8 cm. At follow-up hysteroscopy, the conversion of partially intramural myomas into totally or prevalently intracavitary ones was observed in 93.2% (55/59) of cases. In 2 of 3 cases of failure, the myomas' size was>4 cm. One patient was excluded from the study because of the occurrence of total spontaneous expulsion of the myoma at the subsequent menstrual cycle. Our preliminary findings seem to support the safety and the effectiveness of the OPPIuM procedure by reporting the conversion of myomas with intramural development>1.5 cm into totally or prevalently intracavitary ones in nearly 93% of cases. Such technique may allow surgeons to perform resectoscopic surgery more safely and quickly as dealing with prevalently

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...

A patient-preference cohort study of office versus inpatient uterine polyp treatment for abnormal uterine bleeding.

Science.gov (United States)

Cooper, Natalie A M; Middleton, Lee; Smith, Paul; Denny, Elaine; Stobert, Lynda; Daniels, Jane; Clark, T Justin

2016-01-01

Uterine polyps can cause abnormal bleeding in women. Conventional practise is to remove them under general anaesthesia but advances in technology have made it possible to perform polypectomy in the office setting. We conducted a patient-preference study to explore women's preferences for treatment setting and to evaluate the effectiveness and treatment experience of women undergoing uterine polypectomy. Three hundred ninety-nine women with abnormal uterine bleeding who were found to have uterine polyps at diagnostic hysteroscopy were recruited. Office polypectomies were performed in office hysteroscopy clinics, and inpatient procedures were undertaken in operating theatres. Three hundred twenty-four of 399 (81 %) expressed a preference for office treatment. There was no difference found between office treatment and inpatient treatment in terms of alleviating abnormal uterine bleeding as assessed by patients and in improving disease-specific quality of life. Acceptability was lower and patient pain scores were significantly higher in the office group. When offered a choice of treatment setting for uterine polypectomy, patients have a preference for office over inpatient treatment. Ambulatory gynaecology services should be available within healthcare systems to meet patient demand.

Hysteroscopic view of uterine cavity after normal and PPROM pregnancies

Directory of Open Access Journals (Sweden)

Roshan Nikbakht

2015-01-01

Full Text Available Background: Preterm premature rupture of membranes (PPROM occurs in 17% of pregnancies, which leads to 20% of perinatal death. According to previous studies uterine anomalies are one of the risk factors for preterm birth, PPROM and pregnancies complications. The aim of this study was to evaluate the relationship between PPROM and rupture of membrane (ROM with uterine cavity anomalies based on hysteroscopic findings. Methods: This cross-sectional study was conducted in Imam Khomeini Hospital, Ahvaz, Iran, from May 2011 to May 2012. After conducting a pilot study, 66 nulliparous pregnant women at 14-37 weeks of pregnancy with PPROM and ROM were selected randomly. Then the women were evaluated by hysteroscopy at least six weeks after delivery or miscarriage. The control group includes 66 women with at least one normal pregnancy (without history of PPROM, secondary infertility or recurrent abortion, who underwent diagnostic or therapeutic hysteroscopy for other reasons than PPROM. The hysteroscope instrument specifications were KARL STORZ model (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany, inner sheet 26153 BI, outer sheet 26153 BO, and BA lens with 30 degree. Normal saline solution (Sodium Chloride 0.9% also was applied as distention medium. The study was approved by Ethic Committee of Ahvaz Jundihspur University of Medical Sciences. Informed consent was obtained for all participants. Results: Overall, the frequency of uterine anomalies in case and control groups was 12.12% and 3%, respectively (P<0.05 based on Chi-square test. Possibility of uterine cavity anomalies in the women with preterm premature rupture of membranes (PPROM was significantly higher than the women with normal pregnancy (OR=4.41, CI 95%: 0.9-21/63. About 3% of patients in the case group had undefined uterine anomalies. This anomaly was not in mentioned uterine anomalies classification of American fertility association. We did not observe such anomaly in control group

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

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

Training and Assessment of Hysteroscopic Skills

DEFF Research Database (Denmark)

Savran, Mona Meral; Sørensen, Stine Maya Dreier; Konge, Lars

2016-01-01

OBJECTIVE: The aim of this systematic review was to identify studies on hysteroscopic training and assessment. DESIGN: PubMed, Excerpta Medica, the Cochrane Library, and Web of Science were searched in January 2015. Manual screening of references and citation tracking were also performed. Studies...... on hysteroscopic educational interventions were selected without restrictions on study design, populations, language, or publication year. A qualitative data synthesis including the setting, study participants, training model, training characteristics, hysteroscopic skills, assessment parameters, and study...... outcomes was performed by 2 authors working independently. Effect sizes were calculated when possible. Overall, 2 raters independently evaluated sources of validity evidence supporting the outcomes of the hysteroscopy assessment tools. RESULTS: A total of 25 studies on hysteroscopy training were identified...

TRANSVAGINAL SONOGRAPHY COMBINED WITH SALINE CONTRAST SONOHYSTEROGRAPHY IN EVALUATING THE UTERINE CAVITY IN PREMENOPAUSAL PATIENTS WITH ABNORMAL UTERINE BLEEDING

Directory of Open Access Journals (Sweden)

K. G. M. Premleel

2016-06-01

Full Text Available OBJECTIVES To evaluate whether saline contrast sonohysterography (SCSH improved the diagnostic accuracy of transvaginal sonography (TVS for predicting endometrial abnormality in premenopausal patients with abnormal uterine bleeding. PATIENTS AND METHODS The uterine cavity was evaluated with TVS and SCSH in 60 premenopausal patients with abnormal uterine bleeding. All 58 patients underwent operative hysteroscopy or hysterectomy within 4 months which provided a detailed description of the uterine cavity and was used as the true value for exclusion of polyps and submucous myomas. RESULT Out of 60 patients, 45 had uterine abnormalities on TVS and SCSH and rest of the patients who appeared normal but had other abnormalities such as ovarian haemorrhagic cyst. Out of the 45 patients, 9 patients had submucous myomas and 9 were diagnosed as endometrial polyp. The findings were confirmed using hysterectomy/hysteroscopy/endometrial sampling. CONCLUSION The use of TVS without saline contrast left nine submucosal fibroids and five in nine of the polyps undiagnosed in referred patients with complaints of abnormal bleeding. It also helps in reducing the rate of more invasive procedures such as hysteroscopy. However, studies carried out for longer duration and large study population are required to validate our findings

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.

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

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...

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)

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.

Fluorescence diagnosis of pre-tumor and tumor pathology of endometrium

Directory of Open Access Journals (Sweden)

E. V. Filonenko

2014-01-01

Full Text Available The technique of fluorescence hysteroscopy with Alasens includes visual assessment of fluorescence of Alasens-induced protoporphyrin IX and local fluorescence spectroscopy. The technique allows to improve the efficacy of early diagnosis for endometrial pathology including early endometrial cancer, to assess definitely an extent of pre-tumor and tumor process. The sensitivity of fluorescence hysteroscopy accounts for 100%, the specificity – 98%. 

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.

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

Training and Assessment of Hysteroscopic Skills: A Systematic Review.

Science.gov (United States)

Savran, Mona Meral; Sørensen, Stine Maya Dreier; Konge, Lars; Tolsgaard, Martin G; Bjerrum, Flemming

2016-01-01

The aim of this systematic review was to identify studies on hysteroscopic training and assessment. PubMed, Excerpta Medica, the Cochrane Library, and Web of Science were searched in January 2015. Manual screening of references and citation tracking were also performed. Studies on hysteroscopic educational interventions were selected without restrictions on study design, populations, language, or publication year. A qualitative data synthesis including the setting, study participants, training model, training characteristics, hysteroscopic skills, assessment parameters, and study outcomes was performed by 2 authors working independently. Effect sizes were calculated when possible. Overall, 2 raters independently evaluated sources of validity evidence supporting the outcomes of the hysteroscopy assessment tools. A total of 25 studies on hysteroscopy training were identified, of which 23 were performed in simulated settings. Overall, 10 studies used virtual-reality simulators and reported effect sizes for technical skills ranging from 0.31 to 2.65; 12 used inanimate models and reported effect sizes for technical skills ranging from 0.35 to 3.19. One study involved live animal models; 2 studies were performed in clinical settings. The validity evidence supporting the assessment tools used was low. Consensus between the 2 raters on the reported validity evidence was high (94%). This systematic review demonstrated large variations in the effect of different tools for hysteroscopy training. The validity evidence supporting the assessment of hysteroscopic skills was limited. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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)

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.

Comparison of two modalities: a novel technique, 'chromohysteroscopy', and blind endometrial sampling for the evaluation of abnormal uterine bleeding.

Science.gov (United States)

Alay, Asli; Usta, Taner A; Ozay, Pinar; Karadugan, Ozgur; Ates, Ugur

2014-05-01

The objective of this study was to compare classical blind endometrial tissue sampling with hysteroscopic biopsy sampling following methylene blue dyeing in premenopausal and postmenopausal patients with abnormal uterine bleeding. A prospective case-control study was carried out in the Office Hysteroscopy Unit. Fifty-four patients with complaints of abnormal uterine bleeding were evaluated. Data of 38 patients were included in the statistical analysis. Three groups were compared by examining samples obtained through hysteroscopic biopsy before and after methylene blue dyeing, and classical blind endometrial tissue sampling. First, uterine cavity was evaluated with office hysteroscopy. Methylene blue dye was administered through the hysteroscopic inlet. Tissue samples were obtained from stained and non-stained areas. Blind endometrial sampling was performed in the same patients immediately after the hysteroscopy procedure. The results of hysteroscopic biopsy from methylene blue stained and non-stained areas and blind biopsy were compared. No statistically significant differences were determined in the comparison of biopsy samples obtained from methylene-blue stained, non-stained areas and blind biopsy (P > 0.05). We suggest that chromohysteroscopy is not superior to endometrial sampling in cases of abnormal uterine bleeding. Further studies with greater sample sizes should be performed to assess the validity of routine use of endometrial dyeing. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

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....

AAGL Practice Report

DEFF Research Database (Denmark)

Munro, Malcolm G; Storz, Karl; Abbott, Jason A

2013-01-01

The objective of this guideline is to provide clinicians with evidence-based information about commonly used and available hysteroscopic distending media to guide them in their performance of both diagnostic and operative hysteroscopy. While necessary for the performance of hysteroscopy and hyste...... is critical for the safe performance of hysteroscopic procedures. This report was developed under the direction of the Practice Committee of the AAGL as a service to their members and other practicing clinicians....

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

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...

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)

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.

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…

Hysteroscopic management of a stenotic cervix.

Science.gov (United States)

Suen, Michael W H; Bougie, Olga; Singh, Sukhbir S

2017-06-01

To demonstrate an approach to the hysteroscopic management of a stenotic cervix. Step-by-step explanation of the techniques using video and animation (educational video). Academic tertiary level referral center. Patients with cervical stenosis, inclusive of both reproductive age and postmenopausal women. Gynecologists require intrauterine access for many procedures, but a stenotic cervix can obstruct surgery. Blind dilation of a stenotic cervix can lead to a cervical laceration or uterine perforation, with concomitant complications. The hysteroscopic management of a stenotic cervix includes optimizing the surgical environment, performing vaginoscopy and "no-touch" hysteroscopy, and revision of the cervical canal. Revision can be performed using microscissors, micrograspers, or a cutting loop electrode. Partial cervical canal excision to aid in hysteroscopy access should be reserved in women who are not interested in future pregnancy or those who are postmenopausal. Outpatient hysteroscopy uses smaller instruments and shows operative success with patient satisfaction. Although these techniques are demonstrated in an outpatient hysteroscopy setting, they can be adapted for use in an operating theater. The individual steps and approach are emphasized. Intrauterine access can be achieved with various techniques. The "see-and-treat" approach demonstrated in this video can allow access into the uterine cavity despite a stenotic cervix. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Pain Management for Gynecologic Procedures in the Office.

Science.gov (United States)

Ireland, Luu Doan; Allen, Rebecca H

2016-02-01

Satisfactory pain control for women undergoing office gynecologic procedures is critical for both patient comfort and procedure success. Therefore, it is important for clinicians to be aware of the safety and efficacy of different pain control regimens. This article aimed to review the literature regarding pain control regimens for procedures such as endometrial biopsy, intrauterine device insertion, colposcopy and loop electrosurgical excisional procedure, uterine aspiration, and hysteroscopy. A search of published literature using PubMed was conducted using the following keywords: "pain" or "anesthesia." These terms were paired with the following keywords: "intrauterine device" or "IUD," "endometrial biopsy," "uterine aspiration" or "abortion," "colposcopy" or "loop electrosurgical excisional procedure" or "LEEP," "hysteroscopy" or "hysteroscopic sterilization." The search was conducted through July 2015. Articles were hand reviewed and selected by the authors for study quality. Meta-analyses and randomized controlled trials were prioritized. Although local anesthesia is commonly used for gynecologic procedures, a multimodal approach may be more effective including oral medication, a dedicated emotional support person, and visual or auditory distraction. Women who are nulliparous, are postmenopausal, have a history of dysmenorrhea, or suffer from anxiety are more likely to experience greater pain with gynecologic procedures. Evidence for some interventions exists; however, the interpretation of intervention comparisons is limited by the use of different regimens, pain measurement scales, patient populations, and procedure techniques. There are many options for pain management for office gynecologic procedures, and depending on the procedure, different modalities may work best. The importance of patient counseling and selection cannot be overstated.

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

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...

Hysteroscopic resection on virtual reality simulator: What do we measure?

Science.gov (United States)

Panel, P; Neveu, M-E; Villain, C; Debras, F; Fernandez, H; Debras, E

2018-03-03

The objective was to compare results of two groups of population (novices and experts) on a virtual reality simulator of hysteroscopy resection for different metrics and for a multimetric score to assess its construct validity. Nineteen gynecologist who had at least 5 years of experience with hysteroscopy and self-evaluated their expertise at 4/5 or 5/5 were included as expert population. Twenty first-year gynecology residents in Paris were included as novice population. A standardized set of 4 hysteroscopy resection cases (polypectomy, myomectomy, roller ball endometrial ablation and septum resection) was performed on a virtual reality simulator (HystSim™) by the group of novices and experts. Results obtained on the simulator for overall score and for the parameters were compared by applying the Mann-Whitney test. Overall score of novices and experts were significantly different for three resection cases (polypectomy Pvirtual reality simulator. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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,

Blocked Randomization with Randomly Selected Block Sizes

Directory of Open Access Journals (Sweden)

Jimmy Efird

2010-12-01

Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

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African Journals Online (AJOL)

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was achieved in 45.5% of cases and 27.3% conceived during the follow up period. No change in menstrual ... screening tests for intra-uterine adhesions, hysteroscopy remains .... Although the sample size in this study is small, there is need to ...

[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.

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

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.

Staging in local endometrial carcinoma

International Nuclear Information System (INIS)

Thorvinger, B.; Gudmundsson, T.; Horvath, G.; Forsberg, L.; Holtaas, S.; Lund Univ.

1989-01-01

Possible deep (more than an inner third of the uterine wall) myometrial invasion and cervical extension of endometrial carcinoma were evaluated prospectively using magnetic resonance (MR) and transabdominal real-time sonography (US) in 20 and 10 patients, respectively. The data obtained from these examinations were compared with hysterosalpingography (HSG) and clinical modalities including hysteroscopy, sounding and histopathologic findings after surgery. The concordance of outlining cervical extension was between MR and hysteroscopy 85 per cent, and between US and hysteroscopy 50 per cent. Deep myometrial tumor invasion was suggested in 4/10 patients by US and in 6/20 by MR, and was confirmed in all but one in each group at histologic examination of the resected uterus. There were no false negative US or MR examinations. Transabdominal US did not prove accurate in defining local endometrial carcinoma (distinguishing between stages I and II), but it may be used as an additional tool in revealing myometrial invasion. MR, however, seems to refine the delineation of uterine tumor growth. (orig.)

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.

Quantum random flip-flop and its applications in random frequency synthesis and true random number generation

Energy Technology Data Exchange (ETDEWEB)

Stipčević, Mario, E-mail: mario.stipcevic@irb.hr [Photonics and Quantum Optics Research Unit, Center of Excellence for Advanced Materials and Sensing Devices, Ruđer Bošković Institute, Bijenička 54, 10000 Zagreb (Croatia)

2016-03-15

In this work, a new type of elementary logic circuit, named random flip-flop (RFF), is proposed, experimentally realized, and studied. Unlike conventional Boolean logic circuits whose action is deterministic and highly reproducible, the action of a RFF is intentionally made maximally unpredictable and, in the proposed realization, derived from a fundamentally random process of emission and detection of light quanta. We demonstrate novel applications of RFF in randomness preserving frequency division, random frequency synthesis, and random number generation. Possible usages of these applications in the information and communication technology, cryptographic hardware, and testing equipment are discussed.

Curvature of random walks and random polygons in confinement

International Nuclear Information System (INIS)

Diao, Y; Ernst, C; Montemayor, A; Ziegler, U

2013-01-01

The purpose of this paper is to study the curvature of equilateral random walks and polygons that are confined in a sphere. Curvature is one of several basic geometric properties that can be used to describe random walks and polygons. We show that confinement affects curvature quite strongly, and in the limit case where the confinement diameter equals the edge length the unconfined expected curvature value doubles from π/2 to π. To study curvature a simple model of an equilateral random walk in spherical confinement in dimensions 2 and 3 is introduced. For this simple model we derive explicit integral expressions for the expected value of the total curvature in both dimensions. These expressions are functions that depend only on the radius R of the confinement sphere. We then show that the values obtained by numeric integration of these expressions agrees with numerical average curvature estimates obtained from simulations of random walks. Finally, we compare the confinement effect on curvature of random walks with random polygons. (paper)

Vaginal vault suspension during hysterectomy for benign indications: a prospective register study of agreement on terminology and surgical procedure.

Science.gov (United States)

Bonde, Lisbeth; Noer, Mette Calundann; Møller, Lars Alling; Ottesen, Bent; Gimbel, Helga

2017-07-01

Several suspension methods are used to try to prevent pelvic organ prolapse (POP) after hysterectomy. We aimed to evaluate agreement on terminology and surgical procedure of these methods. We randomly chose 532 medical records of women with a history of hysterectomy from the Danish Hysterectomy and Hysteroscopy Database (DHHD). Additionally, we video-recorded 36 randomly chosen hysterectomies. The hysterectomies were registered in the DHHD. The material was categorized according to predefined suspension methods. Agreement compared suspension codes in DHHD (gynecologists' registrations) with medical records (gynecologists' descriptions) and with videos (reviewers' categorizations) respectively. Whether the vaginal vault was suspended (pooled suspension) or not (no suspension method + not described) was analyzed, in addition to each suspension method. Regarding medical records, agreement on terminology was good among patients undergoing pooled suspension in cases of hysterectomy via the abdominal and vaginal route (agreement 78.7, 92.3%). Regarding videos, agreement on surgical procedure was good among pooled suspension patients in cases of hysterectomy via the abdominal, laparoscopic, and vaginal routes (agreement 88.9, 97.8, 100%). Agreement on individual suspension methods differed regarding both medical records (agreement 0-90.1%) and videos (agreement 0-100%). Agreement on terminology and surgical procedure regarding suspension method was good in respect of pooled suspension. However, disagreement was observed when individual suspension methods and operative details were scrutinized. Better consensus of terminology and surgical procedure is warranted to enable further research aimed at preventing POP among women undergoing hysterectomy.

Random walk of passive tracers among randomly moving obstacles

OpenAIRE

Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-01-01

Background: This study is mainly motivated by the need of understanding how the diffusion behaviour of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. Method: By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random en...

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....

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

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

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.

Pseudo-random number generator based on asymptotic deterministic randomness

Science.gov (United States)

Wang, Kai; Pei, Wenjiang; Xia, Haishan; Cheung, Yiu-ming

2008-06-01

A novel approach to generate the pseudorandom-bit sequence from the asymptotic deterministic randomness system is proposed in this Letter. We study the characteristic of multi-value correspondence of the asymptotic deterministic randomness constructed by the piecewise linear map and the noninvertible nonlinearity transform, and then give the discretized systems in the finite digitized state space. The statistic characteristics of the asymptotic deterministic randomness are investigated numerically, such as stationary probability density function and random-like behavior. Furthermore, we analyze the dynamics of the symbolic sequence. Both theoretical and experimental results show that the symbolic sequence of the asymptotic deterministic randomness possesses very good cryptographic properties, which improve the security of chaos based PRBGs and increase the resistance against entropy attacks and symbolic dynamics attacks.

Pseudo-random number generator based on asymptotic deterministic randomness

International Nuclear Information System (INIS)

Wang Kai; Pei Wenjiang; Xia Haishan; Cheung Yiuming

2008-01-01

A novel approach to generate the pseudorandom-bit sequence from the asymptotic deterministic randomness system is proposed in this Letter. We study the characteristic of multi-value correspondence of the asymptotic deterministic randomness constructed by the piecewise linear map and the noninvertible nonlinearity transform, and then give the discretized systems in the finite digitized state space. The statistic characteristics of the asymptotic deterministic randomness are investigated numerically, such as stationary probability density function and random-like behavior. Furthermore, we analyze the dynamics of the symbolic sequence. Both theoretical and experimental results show that the symbolic sequence of the asymptotic deterministic randomness possesses very good cryptographic properties, which improve the security of chaos based PRBGs and increase the resistance against entropy attacks and symbolic dynamics attacks

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.

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...

[Efficiency of saline contrast hysterosonography for evaluating the uterine cavity].

Science.gov (United States)

de Kroon, C D; Jansen, F W; Trimbos, J B

2003-08-09

Diagnostic hysteroscopy is the standard investigation performed in the case of abnormal vaginal blood loss. More recently there has been increasing interest for minimal invasive saline contrast hysterosonography (SCHS) as this technique is less painful and less expensive. SCHS is indicated in case of abnormal uterine bleeding (premenopausal and postmenopausal), bleeding while using tamoxifen, suspicion of a congenital uterine abnormality and Asherman's syndrome. As well as intracavity abnormalities (polyps and myomas) SCHS can also be used to evaluate the intramural extension of myomas, which is necessary to assess whether hysteroscopic resection is possible. The sensitivity and specificity of SCHS for demonstrating intracavity abnormalities (with a prevalence of 54%) are 94% (95%-CI; 91-97) and 89% (95%-CI: 85-94) respectively. The positive and negative predictive values are 91% (95%-CI: 87-95) and 92% (95%-CI: 89-97) respectively. SCHS has a short learning curve and can be performed in an outpatient setting. SCHS fails more frequently in postmenopausal women than premenopausal women (12.5% vs. 4.7%; p = 0.03). The chance of a non-conclusive SCHS is 7.6% and is higher if the uterine volume is greater than 600 cm3 (relative risk: 2.63; 95%-CI: 1.05-6.60) and if two or more myomas are present: (RR 2.65; 95%-CI: 1.16-6.10). SCHS is 2 to 9 times cheaper than diagnostic hysteroscopy. It can replace 84% of the diagnostic hysteroscopies. SCHS, in combination with endometrial sampling, whenever indicated, might be able to replace diagnostic hysteroscopy as gold standard in the evaluation of the uterine cavity.

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 ...

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.

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.

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…

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

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

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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...

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.

Random walks, random fields, and disordered systems

CERN Document Server

Černý, Jiří; Kotecký, Roman

2015-01-01

Focusing on the mathematics that lies at the intersection of probability theory, statistical physics, combinatorics and computer science, this volume collects together lecture notes on recent developments in the area. The common ground of these subjects is perhaps best described by the three terms in the title: Random Walks, Random Fields and Disordered Systems. The specific topics covered include a study of Branching Brownian Motion from the perspective of disordered (spin-glass) systems, a detailed analysis of weakly self-avoiding random walks in four spatial dimensions via methods of field theory and the renormalization group, a study of phase transitions in disordered discrete structures using a rigorous version of the cavity method, a survey of recent work on interacting polymers in the ballisticity regime and, finally, a treatise on two-dimensional loop-soup models and their connection to conformally invariant systems and the Gaussian Free Field. The notes are aimed at early graduate students with a mod...

Intracavitary deposits on Essure® hysteroscopic sterilization devices: A case report.

Science.gov (United States)

Maassen, L W; van Gastel, D M; Lentjes, E G W M; Bongers, M Y; Veersema, S

2017-07-01

To study the composition of intracavitary deposits on Essure® hysteroscopic sterilization devices. Case report. Reproductive Medicine and Gynecology department of a University Hospital. A 39 years old patient presenting with a request for surgical removal of Essure® sterilization devices. Diagnostic hysteroscopy showed a crystal like white deposit attached to one of the devices. Diagnostic hysteroscopy and surgical removal of Essure® devices was performed. The deposits were collected and infrared spectroscopy analysis was performed. Chemical composition of the deposits attached to the device. Infrared spectroscopy of the material showed patterns conclusive with calcite (calcium carbonate, CaCO 3 ). Until now, it is not clear if there is a relationship between reported complaints and formation of calcite deposits on Essure®. Infrared spectroscopy of deposits on Essure® devices showed a pattern conclusive with calcite. The relationship between reported complaints and the formation of calcite deposits on Essure® remains unclear.

Misuse of randomization

DEFF Research Database (Denmark)

Liu, Jianping; Kjaergard, Lise Lotte; Gluud, Christian

2002-01-01

The quality of randomization of Chinese randomized trials on herbal medicines for hepatitis B was assessed. Search strategy and inclusion criteria were based on the published protocol. One hundred and seventy-six randomized clinical trials (RCTs) involving 20,452 patients with chronic hepatitis B...... virus (HBV) infection were identified that tested Chinese medicinal herbs. They were published in 49 Chinese journals. Only 10% (18/176) of the studies reported the method by which they randomized patients. Only two reported allocation concealment and were considered as adequate. Twenty percent (30...

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.

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.

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

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.

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 .

An introduction to random sets

CERN Document Server

Nguyen, Hung T

2006-01-01

The study of random sets is a large and rapidly growing area with connections to many areas of mathematics and applications in widely varying disciplines, from economics and decision theory to biostatistics and image analysis. The drawback to such diversity is that the research reports are scattered throughout the literature, with the result that in science and engineering, and even in the statistics community, the topic is not well known and much of the enormous potential of random sets remains untapped.An Introduction to Random Sets provides a friendly but solid initiation into the theory of random sets. It builds the foundation for studying random set data, which, viewed as imprecise or incomplete observations, are ubiquitous in today''s technological society. The author, widely known for his best-selling A First Course in Fuzzy Logic text as well as his pioneering work in random sets, explores motivations, such as coarse data analysis and uncertainty analysis in intelligent systems, for studying random s...

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

Science.gov (United States)

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.

Random walk of passive tracers among randomly moving obstacles.

Science.gov (United States)

Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-04-14

This study is mainly motivated by the need of understanding how the diffusion behavior of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random environment is here considered in the case of a passively diffusing particle among randomly moving and interacting obstacles. The relevant physical quantity which is worked out is the diffusion coefficient of the passive tracer which is computed as a function of the average inter-obstacles distance. The results reported here suggest that if a biomolecule, let us call it a test molecule, moves towards its target in the presence of other independently interacting molecules, its motion can be considerably slowed down.

Office hysteroscopic treatment of a vanishing external uterine orifice in a postmenopausal woman with an obstetrical history of 44 abortions

Directory of Open Access Journals (Sweden)

Maurizio Guida

2015-11-01

Full Text Available Cervical stenosis, defined as cervical scarring of variable degree, represents a significant anatomical impediment to hysteroscopic procedures. Acquired cervical stenoses are more common than congenital forms and they are mainly associated with aging, estrogen–progesteron drugs, cervical trauma or carcinoma. The overcoming of cervical stenosis at office hysteroscopy is challenging and it often fails requiring the scheduling of the patient for an in-patient treatment under general anesthesia. We report the office hysteroscopy treatment of a vanishing external uterine orifice in a postmenopausal woman with an ultrasonographic report of a heterogeneous and thick endometrium suggestive of endometrial pathology, focusing on the main surgical steps to perform an adequate management.

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

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.

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).

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.

Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

Science.gov (United States)

Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

2017-12-01

Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

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...

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.

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

How random is a random vector?

International Nuclear Information System (INIS)

Eliazar, Iddo

2015-01-01

Over 80 years ago Samuel Wilks proposed that the “generalized variance” of a random vector is the determinant of its covariance matrix. To date, the notion and use of the generalized variance is confined only to very specific niches in statistics. In this paper we establish that the “Wilks standard deviation” –the square root of the generalized variance–is indeed the standard deviation of a random vector. We further establish that the “uncorrelation index” –a derivative of the Wilks standard deviation–is a measure of the overall correlation between the components of a random vector. Both the Wilks standard deviation and the uncorrelation index are, respectively, special cases of two general notions that we introduce: “randomness measures” and “independence indices” of random vectors. In turn, these general notions give rise to “randomness diagrams”—tangible planar visualizations that answer the question: How random is a random vector? The notion of “independence indices” yields a novel measure of correlation for Lévy laws. In general, the concepts and results presented in this paper are applicable to any field of science and engineering with random-vectors empirical data.

How random is a random vector?

Science.gov (United States)

Eliazar, Iddo

2015-12-01

Over 80 years ago Samuel Wilks proposed that the "generalized variance" of a random vector is the determinant of its covariance matrix. To date, the notion and use of the generalized variance is confined only to very specific niches in statistics. In this paper we establish that the "Wilks standard deviation" -the square root of the generalized variance-is indeed the standard deviation of a random vector. We further establish that the "uncorrelation index" -a derivative of the Wilks standard deviation-is a measure of the overall correlation between the components of a random vector. Both the Wilks standard deviation and the uncorrelation index are, respectively, special cases of two general notions that we introduce: "randomness measures" and "independence indices" of random vectors. In turn, these general notions give rise to "randomness diagrams"-tangible planar visualizations that answer the question: How random is a random vector? The notion of "independence indices" yields a novel measure of correlation for Lévy laws. In general, the concepts and results presented in this paper are applicable to any field of science and engineering with random-vectors empirical data.

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.

Randomized random walk on a random walk

International Nuclear Information System (INIS)

Lee, P.A.

1983-06-01

This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

Evaluating success of curettage in the surgical treatment of endometrial polyps.

Science.gov (United States)

Hafizi, Leili; Mousavifar, Nezhat; Zirak, Nahid; Khadem, Nayereh; Davarpanah, Sousan; Akhondi, Mohsen

2015-02-01

To determine treatment efficacy of curettage on endometrial polyp. The quasi-experimental pre-and-post study was conducted in 2011-12 at the gynaecology department of Imam Reza Hospital, Mashhad, Iran, and comprised patients who underwent hysteroscopy for endometrial polyp. Location, size, number and base condition of the polyps were recorded before the patient underwent curettage. Hysteroscopy was then performed and the condition of the remaining polyps was compared with initial findings. Also, the remaining polyps were resected. SPSS 13 was used for statistical analysis. There were 51 patients in the study with a mean age of 33.14 ± 8.19 years (range: 23-59 years)Besides, there were 82 polyps; 38(46.3%) having a narrow base, and 44(53.7%) having a wide base. The mean polyp size was 2.39 ± 2.63cm.After performing curettage, 23 (28.0%) polyps were removed completely, 39(47.6%) had size reduction, and 20(24.4%) had no change in size. Curettage could not significantly remove polyps (p < 0.001). Polyps smaller than 2cm were more likely to have been removed compared to the bigger ones (p = 0.003).Polyps with wide base were more significantly removed than those with narrow base (p < 0.001).Further, those with wide base and also smaller than 2 cm were removed more significantly than others (p < 0.001).The location of polyps had no effect on removal probability by curettage (p = 0.114). Curettage was not found to be a reliable method for endometrial polyp removal. If hysteroscopy is not accessible, the size of the polyp should be determined by vaginal sonograghy to estimate the probability of its removal by curettage.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

Science.gov (United States)

Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore

2015-10-01

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal). © The Author(s) 2015.

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

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.

Asymptotic Properties of Multistate Random Walks. II. Applications to Inhomogeneous Periodic and Random Lattices

NARCIS (Netherlands)

Roerdink, J.B.T.M.; Shuler, K.E.

1985-01-01

The previously developed formalism for the calculation of asymptotic properties of multistate random walks is used to study random walks on several inhomogeneous periodic lattices, where the periodically repeated unit cell contains a number of inequivalent sites, as well as on lattices with a random

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.

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

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

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

Random broadcast on random geometric graphs

Energy Technology Data Exchange (ETDEWEB)

Bradonjic, Milan [Los Alamos National Laboratory; Elsasser, Robert [UNIV OF PADERBORN; Friedrich, Tobias [ICSI/BERKELEY; Sauerwald, Tomas [ICSI/BERKELEY

2009-01-01

In this work, we consider the random broadcast time on random geometric graphs (RGGs). The classic random broadcast model, also known as push algorithm, is defined as: starting with one informed node, in each succeeding round every informed node chooses one of its neighbors uniformly at random and informs it. We consider the random broadcast time on RGGs, when with high probability: (i) RGG is connected, (ii) when there exists the giant component in RGG. We show that the random broadcast time is bounded by {Omicron}({radical} n + diam(component)), where diam(component) is a diameter of the entire graph, or the giant component, for the regimes (i), or (ii), respectively. In other words, for both regimes, we derive the broadcast time to be {Theta}(diam(G)), which is asymptotically optimal.

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.

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...

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’....

ICSI pregnancy outcomes following hysteroscopic placement of Essure devices for hydrosalpinx in laparoscopic contraindicated patients.

Science.gov (United States)

Ozgur, Kemal; Bulut, Hasan; Berkkanoglu, Murat; Coetzee, Kevin; Kaya, Gamze

2014-07-01

This study investigated the use of hysteroscopic Essure device placement for the treatment of hydrosalpinx-related infertility in patients with laparoscopic contraindications and compared their pregnancy outcomes following assisted conception treatment with those of patients having had laparoscopic tubal ligation. A total of 102 infertile patients were diagnosed with unilateral or bilateral hydrosalpinges: 26 patients had laparoscopic contraindications and were treated hysterscopically and 76 patients were treated laparoscopically. In total, 66 intracytoplasmic sperm injection (ICSI) and 39 frozen embryo transfer (FET) procedures were performed. In the hysteroscopy group, 13 ICSI and eight FET in 16 patients resulted in 10 pregnancies (pregnancy rates 47.6% per transfer and 62.5% per patient), and in the laparoscopy group, 53 ICSI and 31 FET embryo transfers in 54 patients resulted in 36 pregnancies (pregnancy rates 42.9% per transfer and 66.7% per patient). Live birth rates per assisted reproduction procedure were 23.8% (5/21) in the hysteroscopy group and 32.1% (27/84) for the laparoscopy group. The hysteroscopic placement of Essure devices to isolate hydrosalpinx prior to assisted conception treatment produced pregnancy outcomes comparable to those produced following laparoscopic tubal ligation. The live birth rates indicate that a larger, more comparative, prospectively randomized study is required. Infertile patients with tubal disease require surgical treatment before they can continue with fertility treatment. There are two main surgical methods that can be used, hysteroscopic and laparoscopic, the latter being the standard surgical method. However, some patients have disease that makes the use of laparoscopy inappropriate. For these patients the placement of Essure® devices by hysteroscopic surgery maybe the most suitable treatment method. One hundred and two patients were diagnosed with unilateral or bilateral hydrosalpinges - tubal disease. Twenty six

Does laparoscopy still has a role in modern fertility practice?

Directory of Open Access Journals (Sweden)

Ahmad Mahran

2017-12-01

Full Text Available Background: More than 3 decades after the introduction of in vitro fertilization (IVF and despite the improved success rates of assisted reproductive technologies, the argument for performing laparoscopy as a part of the infertility workup still stands. Objective: To evaluate the role of laparoscopy±hysteroscopy in diagnosis and management of infertility in our setting in view of modern fertility practice. Materials and Methods: This case control study was carried out on 600 infertile women subjected to laparoscopy or combined laparoscopy and hysteroscopy at endoscopy unit in Minia University Hospital, Egypt during the period from January 2012 to December 2014. Results: The causes of infertility as identified by laparoscopy±hysteroscopy were polycystic ovary syndrome (25.1%, tubal factor (30%, uterine cause (4%, and endometriosis (2.7%. No cause was identified in 38.2% of cases. Based on operative findings, women were treated with different options. Expectant management was used in 92 cases (15.3%. Ovulation induction with anti-estrogens or gonadotropins was used in 372 cases (62%. Sixty cases (10% had intrauterine insemination and sixty four cases (10.7% underwent in vitro fertilization (IVF / intracytoplasmic sperm injection (ICSI treatment. Within 1 yr after laparoscopy, 180 cases achieved pregnancy (30%. The most favorable outcome was recorded in women with unexplained infertility (36.7% of cases got pregnant followed by women with polycystic ovary syndrome (27.8%. Participants with uterine and tubal infertility factor achieved pregnancy in 25% and 22.8% of cases, respectively. The worst outcome was recorded in women with endometriosis. Conclusion: Laparoscopy still has an important role in the diagnosis and treatment of infertility.

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

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)

Solid-State Random Lasers

CERN Document Server

Noginov, Mikhail A

2005-01-01

Random lasers are the simplest sources of stimulated emission without cavity, with the feedback provided by scattering in a gain medium. First proposed in the late 60’s, random lasers have grown to a large research field. This book reviews the history and the state of the art of random lasers, provides an outline of the basic models describing their behavior, and describes the recent advances in the field. The major focus of the book is on solid-state random lasers. However, it also briefly describes random lasers based on liquid dyes with scatterers. The chapters of the book are almost independent of each other. So, the scientists or engineers interested in any particular aspect of random lasers can read directly the relevant section. Researchers entering the field of random lasers will find in the book an overview of the field of study. Scientists working in the field can use the book as a reference source.

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.

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.

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.

The Theory of Random Laser Systems

International Nuclear Information System (INIS)

Xunya Jiang

2002-01-01

Studies of random laser systems are a new direction with promising potential applications and theoretical interest. The research is based on the theories of localization and laser physics. So far, the research shows that there are random lasing modes inside the systems which is quite different from the common laser systems. From the properties of the random lasing modes, they can understand the phenomena observed in the experiments, such as multi-peak and anisotropic spectrum, lasing mode number saturation, mode competition and dynamic processes, etc. To summarize, this dissertation has contributed the following in the study of random laser systems: (1) by comparing the Lamb theory with the Letokhov theory, the general formulas of the threshold length or gain of random laser systems were obtained; (2) they pointed out the vital weakness of previous time-independent methods in random laser research; (3) a new model which includes the FDTD method and the semi-classical laser theory. The solutions of this model provided an explanation of the experimental results of multi-peak and anisotropic emission spectra, predicted the saturation of lasing modes number and the length of localized lasing modes; (4) theoretical (Lamb theory) and numerical (FDTD and transfer-matrix calculation) studies of the origin of localized lasing modes in the random laser systems; and (5) proposal of using random lasing modes as a new path to study wave localization in random systems and prediction of the lasing threshold discontinuity at mobility edge

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.

Complications of hysteroscopic surgery: "Beyond the learning curve".

Science.gov (United States)

Shveiky, David; Rojansky, Nathan; Revel, Ariel; Benshushan, Abraham; Laufer, Neri; Shushan, Asher

2007-01-01

To investigate the actual complication rate of hysteroscopic surgery performed by experienced endoscopic surgeons in a single medical center. A prospective descriptive study (Canadian Task Force classification III). An endoscopic gynecology unit at a tertiary care university hospital. Women from 21 to 82 (median 45.0) years, undergoing operative hysteroscopy for uterine disease. Operative hysteroscopy with glycine or saline solution used as an irrigation medium. Data of short-term complications were prospectively collected during surgery and at the 2-week follow-up visit. Six hundred procedures were investigated. The total complication rate was 3%, with 1% of uterine perforations. Two-thirds of the complications were related to cervical dilation or uterine entry, and infertility was found to be a risk factor. Hysteroscopic surgery, performed by a well-trained hysteroscopic surgeon, is a safe procedure with an overall complication rate of 3%. Most complications are related to cervical dilation or uterine entry techniques. Efforts therefore should be focused on identifying the patients at risk and finding novel techniques for cervical priming.

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

Science.gov (United States)

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.

Factors Influencing the Recurrence Potential of Benign Endometrial Polyps after Hysteroscopic Polypectomy.

Directory of Open Access Journals (Sweden)

Jehn-Hsiahn Yang

Full Text Available An endometrial polyp is a frequently encountered gynecologic disease with abnormal uterine bleeding and infertility being the two common presenting problems, and hysteroscopic polypectomy is an effective method to remove them. The postoperative polyp recurrence might result in reappearance of abnormal uterine bleeding or infertility, whereas factors influencing the postoperative recurrence potential have limited data.This case-series report included 168 premenopausal women who suffered from endometrial polyps and underwent hysteroscopic polypectomy. All of them were awaiting a future pregnancy. Office hysteroscopy was done before and after hysteroscopic polypectomy, in which preoperative hysteroscopy examined the number, type, and location of endometrial polyps, and postoperative hysteroscopy checked the polyp recurrence. Surgical indications, either infertility or the presentation of abnormal uterine bleeding, and follow-up duration were recorded.Seventy-three out of 168 (43% women had polyp recurrence after hysteroscopic polypectomy. Multivariate logistic regression analysis revealed that more endometrial polyps (P = 0.015 and longer duration of follow-up (P = 0.004 were significantly associated with an increased risk of postoperative polyp recurrence. The type of endometrial polyps was not correlated with polyp recurrence potential, whereas pedunculated type endometrial polyps were closely related to the presentation of abnormal uterine bleeding (P = 0.001.A higher number of endometrial polyps and longer follow-up duration are associated with a greater potential of polyp recurrence after hysteroscopic polypectomy.

[Intel random number generator-based true random number generator].

Science.gov (United States)

Huang, Feng; Shen, Hong

2004-09-01

To establish a true random number generator on the basis of certain Intel chips. The random numbers were acquired by programming using Microsoft Visual C++ 6.0 via register reading from the random number generator (RNG) unit of an Intel 815 chipset-based computer with Intel Security Driver (ISD). We tested the generator with 500 random numbers in NIST FIPS 140-1 and X(2) R-Squared test, and the result showed that the random number it generated satisfied the demand of independence and uniform distribution. We also compared the random numbers generated by Intel RNG-based true random number generator and those from the random number table statistically, by using the same amount of 7500 random numbers in the same value domain, which showed that the SD, SE and CV of Intel RNG-based random number generator were less than those of the random number table. The result of u test of two CVs revealed no significant difference between the two methods. Intel RNG-based random number generator can produce high-quality random numbers with good independence and uniform distribution, and solves some problems with random number table in acquisition of the random numbers.

The treatment of disc herniation-induced sciatica with infliximab - Results of a randomized, controlled, 3-month follow-up study

NARCIS (Netherlands)

Korhonen, T; Karppinen, J; Paimela, L; Malmivaara, A; Lindgren, KA; Jarvinen, S; Niinimaki, J; Veeger, N; Seitsalo, S; Hurri, H

2005-01-01

Study Design. A randomized controlled trial. Objectives. To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. Summary of Background Data. Recently, we obtained encouraging results in an open-label study of

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

Randomization tests

CERN Document Server

Edgington, Eugene

2007-01-01

Statistical Tests That Do Not Require Random Sampling Randomization Tests Numerical Examples Randomization Tests and Nonrandom Samples The Prevalence of Nonrandom Samples in Experiments The Irrelevance of Random Samples for the Typical Experiment Generalizing from Nonrandom Samples Intelligibility Respect for the Validity of Randomization Tests Versatility Practicality Precursors of Randomization Tests Other Applications of Permutation Tests Questions and Exercises Notes References Randomized Experiments Unique Benefits of Experiments Experimentation without Mani

Random vibrations theory and practice

CERN Document Server

Wirsching, Paul H; Ortiz, Keith

1995-01-01

Random Vibrations: Theory and Practice covers the theory and analysis of mechanical and structural systems undergoing random oscillations due to any number of phenomena— from engine noise, turbulent flow, and acoustic noise to wind, ocean waves, earthquakes, and rough pavement. For systems operating in such environments, a random vibration analysis is essential to the safety and reliability of the system. By far the most comprehensive text available on random vibrations, Random Vibrations: Theory and Practice is designed for readers who are new to the subject as well as those who are familiar with the fundamentals and wish to study a particular topic or use the text as an authoritative reference. It is divided into three major sections: fundamental background, random vibration development and applications to design, and random signal analysis. Introductory chapters cover topics in probability, statistics, and random processes that prepare the reader for the development of the theory of random vibrations a...

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

Directory of Open Access Journals (Sweden)

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

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.

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.

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...

Compositions, Random Sums and Continued Random Fractions of Poisson and Fractional Poisson Processes

Science.gov (United States)

Orsingher, Enzo; Polito, Federico

2012-08-01

In this paper we consider the relation between random sums and compositions of different processes. In particular, for independent Poisson processes N α ( t), N β ( t), t>0, we have that N_{α}(N_{β}(t)) stackrel{d}{=} sum_{j=1}^{N_{β}(t)} Xj, where the X j s are Poisson random variables. We present a series of similar cases, where the outer process is Poisson with different inner processes. We highlight generalisations of these results where the external process is infinitely divisible. A section of the paper concerns compositions of the form N_{α}(tauk^{ν}), ν∈(0,1], where tauk^{ν} is the inverse of the fractional Poisson process, and we show how these compositions can be represented as random sums. Furthermore we study compositions of the form Θ( N( t)), t>0, which can be represented as random products. The last section is devoted to studying continued fractions of Cauchy random variables with a Poisson number of levels. We evaluate the exact distribution and derive the scale parameter in terms of ratios of Fibonacci numbers.

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.

The accuracy of endometrial sampling in women with postmenopausal bleeding: a systematic review and meta-analysis.

Science.gov (United States)

van Hanegem, Nehalennia; Prins, Marileen M C; Bongers, Marlies Y; Opmeer, Brent C; Sahota, Daljit Singh; Mol, Ben Willem J; Timmermans, Anne

2016-02-01

Postmenopausal bleeding (PMB) can be the first sign of endometrial cancer. In case of thickened endometrium, endometrial sampling is often used in these women. In this systematic review, we studied the accuracy of endometrial sampling for the diagnoses of endometrial cancer, atypical hyperplasia and endometrial disease (endometrial pathology, including benign polyps). We systematically searched the literature for studies comparing the results of endometrial sampling in women with postmenopausal bleeding with two different reference standards: blind dilatation and curettage (D&C) and hysteroscopy with histology. We assessed the quality of the detected studies by the QUADAS-2 tool. For each included study, we calculated the fraction of women in whom endometrial sampling failed. Furthermore, we extracted numbers of cases of endometrial cancer, atypical hyperplasia and endometrial disease that were identified or missed by endometrial sampling. We detected 12 studies reporting on 1029 women with postmenopausal bleeding: five studies with dilatation and curettage (D&C) and seven studies with hysteroscopy as a reference test. The weighted sensitivity of endometrial sampling with D&C as a reference for the diagnosis of endometrial cancer was 100% (range 100-100%) and 92% (71-100) for the diagnosis of atypical hyperplasia. Only one study reported sensitivity for endometrial disease, which was 76%. When hysteroscopy was used as a reference, weighted sensitivities of endometrial sampling were 90% (range 50-100), 82% (range 56-94) and 39% (21-69) for the diagnosis of endometrial cancer, atypical hyperplasia and endometrial disease, respectively. For all diagnosis studied and the reference test used, specificity was 98-100%. The weighted failure rate of endometrial sampling was 11% (range 1-53%), while insufficient samples were found in 31% (range 7-76%). In these women with insufficient or failed samples, an endometrial (pre) cancer was found in 7% (range 0-18%). In women with

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).

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.

Relationship of endometrial thickness detected by transvaginal sonography with the results of endometrial biopsy & hysteroscopic directed biopsy in post menopausal bleeding

Directory of Open Access Journals (Sweden)

Vahid Dastjerdi M

2008-05-01

Full Text Available Background: Post-menopausal hemorrhage is one of the most common complains in gynecologic clinics. More than 60% of these cases have abnormal findings in diagnostic work ups. There is contraversy about the best diagnostic method for evaluating post-menopausal hemorrhage. The aim of this study was to evaluate the results of Trans-Vaginal Ultrasonography and compare its result to ones derived from direct endometrial biopsy and Hysteroscopy findings.Methods: In a cross-sectional study, menopausal women who attended the outpatient clinic of Arash Hospital, Tehran University of medical Sciences, from April 2005 to March 2006 with the complain of hemorrhage were evaluated. In all of these patients, after getting informed consent, Trans-Vaginal Ultrasonography, Dilatation and Curettage and Hysteroscopy were performed.Results: The total number of 90 women was recruited to the study with the age range of 41-80 years. The mean age of participants was 53.84 ± 6 years and 4.3 ± 5.1 years had passed from their menopause. The mean thickness of endometrium, measured by Trans Vaginal ultrasonography was 6.25 ± 3.7 millimeter. In the biopsy derived specimens, the most finding pathological presentation was atrophy (48.9% and the Proliferative endometrium had the second prevalence (36.7%. Atrophy (44.4% and Proliferative endometrium (33.3% were the most prevalent finding in Hysteroscopy. There was a significant difference in endometrial thickness between groups of different pathological findings. A significant difference in endometrial thickness was also seen between groups with different Hysteroscopic finding. By grouping the data according to endometrial thickness, it became evident that endometrial thickness can predict the outcome of endometrial biopsy and Hysteroscopic finding efficiently. We used ROC curves to find the best grouping threshold for endometrial thickness to achieve the best sensitivity and specificity.Conclusion: Measuring the endometrial

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.

Intrauterine adhesions as a risk factor for failed first-trimester pregnancy termination.

Science.gov (United States)

Luk, Janelle; Allen, Rebecca H; Schantz-Dunn, Julianna; Goldberg, Alisa B

2007-10-01

Risk factors for failed first-trimester surgical abortion include endometrial distortion caused by leiomyomas, uterine anomalies and malposition and cervical stenosis. This report introduces intrauterine adhesions as an additional risk factor. A multiparous woman presented for pregnancy termination at 6 weeks' gestation. Three suction-curettage attempts failed to remove what appeared to be an intrauterine pregnancy. Rising beta-hCG levels and concern for an interstitial ectopic pregnancy prompted a diagnostic laparoscopy and exploratory laparotomy without the identification of an ectopic pregnancy. After methotrexate treatment failed, the patient underwent ultrasound-guided hysteroscopy and suction curettage using a cannula with a whistle-cut aperture for the successful removal of a pregnancy implanted behind intrauterine adhesions. Intrauterine adhesions are a cause of failed surgical abortion. Ultrasound-guided hysteroscopy may be required for diagnosis.

Secondary infertility caused by the retention of fetal bones after an abortion: a case report

Directory of Open Access Journals (Sweden)

Kramer Hannah MC

2008-06-01

Full Text Available Abstract Introduction Unwanted contraception through prolonged retention of fetal bone is a rare cause of secondary infertility. It is usually associated with a history of abortion, either spontaneous or induced. Case presentation We describe a case of intrauterine retention of fetal bone diagnosed 8 years after the termination of a pregnancy. The patient had no complaints of pain, irregular vaginal bleeding or discharge. A hysteroscopy was performed and irregular structures were removed. These fragments were fetal bones, which probably functioned as an intrauterine contraceptive device. After removal of the fetal bone fragments the patient conceived spontaneously within 6 months. Conclusion This case report stresses the importance of taking a thorough history and evaluation of the endometrium by transvaginal ultrasound or hysteroscopy in women with secondary infertility.

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

Sudan Journal of Medical Sciences - Vol 9, No 4 (2014)

African Journals Online (AJOL)

Hysteroscopy in Libyan women with Recurrent Pregnancy Loss · EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT. AM Elbareg, FM Essadi, MO Elmehashi, KI Anwar, I Adam, 239-244 ...

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

Science.gov (United States)

Dippel, Eric J; Makam, Prakash; Kovach, Richard; George, Jon C; Patlola, Raghotham; Metzger, D Christopher; Mena-Hurtado, Carlos; Beasley, Robert; Soukas, Peter; Colon-Hernandez, Pedro J; Stark, Matthew A; Walker, Craig

2015-01-01

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study

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

Random a-adic groups and random net fractals

Energy Technology Data Exchange (ETDEWEB)

Li Yin [Department of Mathematics, Nanjing University, Nanjing 210093 (China)], E-mail: Lyjerry7788@hotmail.com; Su Weiyi [Department of Mathematics, Nanjing University, Nanjing 210093 (China)], E-mail: suqiu@nju.edu.cn

2008-08-15

Based on random a-adic groups, this paper investigates the relationship between the existence conditions of a positive flow in a random network and the estimation of the Hausdorff dimension of a proper random net fractal. Subsequently we describe some particular random fractals for which our results can be applied. Finally the Mauldin and Williams theorem is shown to be very important example for a random Cantor set with application in physics as shown in E-infinity theory.

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.

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.

Non-compact random generalized games and random quasi-variational inequalities

OpenAIRE

Yuan, Xian-Zhi

1994-01-01

In this paper, existence theorems of random maximal elements, random equilibria for the random one-person game and random generalized game with a countable number of players are given as applications of random fixed point theorems. By employing existence theorems of random generalized games, we deduce the existence of solutions for non-compact random quasi-variational inequalities. These in turn are used to establish several existence theorems of noncompact generalized random ...

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.

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.

Avaliação de morfologia e histologia endometrial de mulheres após a menopausa Assessment of endometrial morphology and histology in postmenopausal women

Directory of Open Access Journals (Sweden)

Luis Paulo Galvao Wolff

2010-01-01

Full Text Available OBJETIVO: Avaliar ambulatorialmente a morfologia e histologia endometrial de mulheres sem sangramento genital após a menopausa. MÉTODOS: Em estudo descritivo foram selecionadas 52 mulheres, após a menopausa, entre 50 e 60 anos, sem terapia hormonal nos últimos seis meses. Todas foram submetidas a exame ultrassonográfico, histeroscópico e biópsias endometriais. RESULTADOS: Das 52 mulheres selecionadas 32 (61,5% apresentaram ultrassonografia normal, cavidade uterina normal com endométrio atrófico à histeroscopia, confirmada pela biópsia endometrial. Vinte (38,4% apresentaram achados histeroscópicos ou histológicos anormais, sendo que apenas cinco destas mostraram endométrio com espessura superior a cinco milímetros ao ultrassom. CONCLUSÃO: A histeroscopia diagnóstica associada à biópsia aspirativa (Pipelle pode evidenciar alterações não observadas ao ultrassom transvaginal.OBJECTIVE: Evaluate in outpatients , the endometrial morphology and histology of non- bleeding postmenopausal women. METHODS: We conducted a descriptive study where 52 menopausal women were selected, between 50 and 60 years of age, who had not used hormone replacement therapy in the last six months and did not present any kind of vaginal bleeding after menopause. These women underwent ultrasound examination, hysteroscopy and biopsy, and then endometrial findings were analyzed. RESULTS: Of the 52 women selected, thirty two (61,5% had normal ultrasound, normal uterine cavity with atrophic endometrium, hysteroscopy, confirmed by endometrial biopsy. Twenty (38,4% had hysteroscopuc and histologic alterations and only five women showed by ultrasound an endometrial thickness of more than five millimeters. CONCLUSION: Diagnostic Hysteroscopy associated with aspiration biopsy (Pipelle performed in the day care facility can reveal endometrial alterations that cannot be diagnosed by transvaginal ultrasound.

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

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.

How random are random numbers generated using photons?

International Nuclear Information System (INIS)

Solis, Aldo; Angulo Martínez, Alí M; Ramírez Alarcón, Roberto; Cruz Ramírez, Hector; U’Ren, Alfred B; Hirsch, Jorge G

2015-01-01

Randomness is fundamental in quantum theory, with many philosophical and practical implications. In this paper we discuss the concept of algorithmic randomness, which provides a quantitative method to assess the Borel normality of a given sequence of numbers, a necessary condition for it to be considered random. We use Borel normality as a tool to investigate the randomness of ten sequences of bits generated from the differences between detection times of photon pairs generated by spontaneous parametric downconversion. These sequences are shown to fulfil the randomness criteria without difficulties. As deviations from Borel normality for photon-generated random number sequences have been reported in previous work, a strategy to understand these diverging findings is outlined. (paper)

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.

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

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...

Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

International Nuclear Information System (INIS)

Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

2016-01-01

Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

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...

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.

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

Science.gov (United States)

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

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.

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

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

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

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)...

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...

Tuberculose als ongebruikelijke oorzaak van oligoamenorroe en infertiliteit

NARCIS (Netherlands)

Goddijn, M.; Emanuel, M. H.; Wiers, P. W.; Eastham, W. N.

1997-01-01

An 28-year-old Moroccan woman with primary infertility and OLIGO-amenorrhea was referred for hysteroscopic synechiolysis. When a diagnostic hysteroscopy was performed, a bizarre, irregular, 'cloudy' endometrium was seen. The diagnosis endometrial tuberculosis was confirmed by histological

Average beta-beating from random errors

CERN Document Server

Tomas Garcia, Rogelio; Langner, Andy Sven; Malina, Lukas; Franchi, Andrea; CERN. Geneva. ATS Department

2018-01-01

The impact of random errors on average β-beating is studied via analytical derivations and simulations. A systematic positive β-beating is expected from random errors quadratic with the sources or, equivalently, with the rms β-beating. However, random errors do not have a systematic effect on the tune.

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

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.

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.

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.

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.

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

Random walks and diffusion on networks

Science.gov (United States)

Masuda, Naoki; Porter, Mason A.; Lambiotte, Renaud

2017-11-01

Random walks are ubiquitous in the sciences, and they are interesting from both theoretical and practical perspectives. They are one of the most fundamental types of stochastic processes; can be used to model numerous phenomena, including diffusion, interactions, and opinions among humans and animals; and can be used to extract information about important entities or dense groups of entities in a network. Random walks have been studied for many decades on both regular lattices and (especially in the last couple of decades) on networks with a variety of structures. In the present article, we survey the theory and applications of random walks on networks, restricting ourselves to simple cases of single and non-adaptive random walkers. We distinguish three main types of random walks: discrete-time random walks, node-centric continuous-time random walks, and edge-centric continuous-time random walks. We first briefly survey random walks on a line, and then we consider random walks on various types of networks. We extensively discuss applications of random walks, including ranking of nodes (e.g., PageRank), community detection, respondent-driven sampling, and opinion models such as voter models.

Virial expansion for almost diagonal random matrices

Science.gov (United States)

Yevtushenko, Oleg; Kravtsov, Vladimir E.

2003-08-01

Energy level statistics of Hermitian random matrices hat H with Gaussian independent random entries Higeqj is studied for a generic ensemble of almost diagonal random matrices with langle|Hii|2rangle ~ 1 and langle|Hi\

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

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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.

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.

POLICY IMPLICATIONS OF ADJUSTING RANDOMIZED TRIAL DATA FOR ECONOMIC EVALUATIONS: A DEMONSTRATION FROM THE ASCUS-LSIL TRIAGE STUDY

Science.gov (United States)

Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.

2013-01-01

Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881

Simulation Training in Hysteroscopic Surgery

NARCIS (Netherlands)

Janse, J.A.

2014-01-01

Hysteroscopy detects uterine cavity pathology by direct visualisation of the endometrial lining, making use of a vaginally inserted endoscope. The additional insertion of an instrument through the endoscope provides the opportunity for obtainment of histology and treatment of pathologies, and for

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

Science.gov (United States)

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

2009-02-01

Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

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

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.

A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

Science.gov (United States)

Rosenthal, Meagen M; Tsuyuki, Ross T; Houle, Sherilyn Kd

2015-01-01

Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension. A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the

Random pulse generator

International Nuclear Information System (INIS)

Guo Ya'nan; Jin Dapeng; Zhao Dixin; Liu Zhen'an; Qiao Qiao; Chinese Academy of Sciences, Beijing

2007-01-01

Due to the randomness of radioactive decay and nuclear reaction, the signals from detectors are random in time. But normal pulse generator generates periodical pulses. To measure the performances of nuclear electronic devices under random inputs, a random generator is necessary. Types of random pulse generator are reviewed, 2 digital random pulse generators are introduced. (authors)

The RANDOM computer program: A linear congruential random number generator

Science.gov (United States)

Miles, R. F., Jr.

1986-01-01

The RANDOM Computer Program is a FORTRAN program for generating random number sequences and testing linear congruential random number generators (LCGs). The linear congruential form of random number generator is discussed, and the selection of parameters of an LCG for a microcomputer described. This document describes the following: (1) The RANDOM Computer Program; (2) RANDOM.MOD, the computer code needed to implement an LCG in a FORTRAN program; and (3) The RANCYCLE and the ARITH Computer Programs that provide computational assistance in the selection of parameters for an LCG. The RANDOM, RANCYCLE, and ARITH Computer Programs are written in Microsoft FORTRAN for the IBM PC microcomputer and its compatibles. With only minor modifications, the RANDOM Computer Program and its LCG can be run on most micromputers or mainframe computers.

Random matrix approach to plasmon resonances in the random impedance network model of disordered nanocomposites

Science.gov (United States)

Olekhno, N. A.; Beltukov, Y. M.

2018-05-01

Random impedance networks are widely used as a model to describe plasmon resonances in disordered metal-dielectric and other two-component nanocomposites. In the present work, the spectral properties of resonances in random networks are studied within the framework of the random matrix theory. We have shown that the appropriate ensemble of random matrices for the considered problem is the Jacobi ensemble (the MANOVA ensemble). The obtained analytical expressions for the density of states in such resonant networks show a good agreement with the results of numerical simulations in a wide range of metal filling fractions 0

Association Between Telomere Length and Risk of Cancer and Non-Neoplastic Diseases: A Mendelian Randomization Study

NARCIS (Netherlands)

Haycock, P.C.; Burgess, S.; Nounu, A.; Zheng, J.; Okoli, G.N.; Bowden, J.; Wade, K.H.; Timpson, N.J.; Evans, D.M.; Willeit, P.; Aviv, A.; Gaunt, T.R.; Hemani, G.; Mangino, M.; Ellis, H.P.; Kurian, K.M.; Pooley, K.A.; Eeles, R.A.; Lee, J.E.; Fang, S.; Chen, W.V.; Law, M.H.; Bowdler, L.M.; Iles, M.M.; Yang, Q.; Worrall, B.B.; Markus, H.S.; Hung, R.J.; Amos, C.I.; Spurdle, A.B.; Thompson, D.J.; O'Mara, T.A.; Wolpin, B.; Amundadottir, L.; Stolzenberg-Solomon, R.; Trichopoulou, A.; Onland-Moret, N.C.; Lund, E.; Duell, E.J.; Canzian, F.; Severi, G.; Overvad, K.; Gunter, M.J.; Tumino, R.; Svenson, U.; Rij, A. van; Baas, A.F.; Bown, M.J.; Samani, N.J.; t'Hof, F.N.G. van; Tromp, G.; Jones, G.T.; Kuivaniemi, H.; Elmore, J.R.; Johansson, M.; McKay, J.; Scelo, G.; Carreras-Torres, R.; Gaborieau, V.; Brennan, P.; Bracci, P.M.; Neale, R.E.; Olson, S.H.; Gallinger, S.; Li, D.; Petersen, G.M.; Risch, H.A.; Klein, A.P.; Han, J.; Abnet, C.C.; Freedman, N.D.; Taylor, P.R.; Maris, J.M.; Aben, K.K.H.; Kiemeney, L.A.; Vermeulen, S.H.; Wiencke, J.K.; Walsh, K.M.; Wrensch, M.; Rice, T.; Turnbull, C.; Litchfield, K.; Paternoster, L.; Standl, M.; Abecasis, G.R.; SanGiovanni, J.P.; Li, Y.; Mijatovic, V.; Sapkota, Y.; Low, S.K.; Zondervan, K.T.; Montgomery, G.W.; Nyholt, D.R.; Heel, D.A. van; Hunt, K.; Arking, D.E.; Ashar, F.N.; Sotoodehnia, N.; Woo, D.; et al.,

2017-01-01

Importance: The causal direction and magnitude of the association between telomere length and incidence of cancer and non-neoplastic diseases is uncertain owing to the susceptibility of observational studies to confounding and reverse causation. Objective: To conduct a Mendelian randomization study,

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.

The hysterosonography in the study of the bled

International Nuclear Information System (INIS)

Trujillo B, Juan Guillermo; Rueda Saenz, Ricardo; Triana, Gustavo

1997-01-01

Hysterosonography (HS) is the sterile saline infusion on the endometrium under sonographic control, to localize any uterine abnormalities to the endocavitary space, and determine endometrial or submucosal origin. Forty patients had HS, with hysteroscopic correlation on 23 patients. Fourteen patients were on reproductive age (Group I) and 9 were peri menopausal (Group II), all of them with abnormal uterine bleeding. Diagnostic accuracy of HSG on Group I was of 92.8%, and 100% on Group II patients. For Group I patients, the main abnormalities were endometrial polyps, submucosal myomas, septae and adherences. For Group II patients, the most frequent findings were polyps and submucosal myomas. We conclude that HS increases the specificity of trans vaginal ultrasound in the characterization of abnormalities of the endometrial cavity, and can establish which require hysteroscopy or other diagnostic or therapeutic methods

Random walk generated by random permutations of {1, 2, 3, ..., n + 1}

International Nuclear Information System (INIS)

Oshanin, G; Voituriez, R

2004-01-01

We study properties of a non-Markovian random walk X (n) l , l = 0, 1, 2, ..., n, evolving in discrete time l on a one-dimensional lattice of integers, whose moves to the right or to the left are prescribed by the rise-and-descent sequences characterizing random permutations π of [n + 1] = {1, 2, 3, ..., n + 1}. We determine exactly the probability of finding the end-point X n = X (n) n of the trajectory of such a permutation-generated random walk (PGRW) at site X, and show that in the limit n → ∞ it converges to a normal distribution with a smaller, compared to the conventional Polya random walk, diffusion coefficient. We formulate, as well, an auxiliary stochastic process whose distribution is identical to the distribution of the intermediate points X (n) l , l < n, which enables us to obtain the probability measure of different excursions and to define the asymptotic distribution of the number of 'turns' of the PGRW trajectories

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research.

Science.gov (United States)

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D; Cui, Licong

2015-11-10

A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f1, f2, ..., fk. The input for each function fi has 3 components: a random number r, an integer n, and input data m. The result, fi(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f1(r1, n1, m1), f2(r2, n2, m2), ..., fk(rk, nk, mk). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result

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.

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.

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

On a randomly imperfect spherical cap pressurized by a random ...

African Journals Online (AJOL)

On a randomly imperfect spherical cap pressurized by a random dynamic load. ... In this paper, we investigate a dynamical system in a random setting of dual ... characterization of the random process for determining the dynamic buckling load ...

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.

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

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.

Teaching Surgical Hysteroscopy with a Computer

Science.gov (United States)

Lefebvre; Cote; Lefebvre

1996-08-01

Using a hysteroscope can be simulated on a computer. It will improve physician training by measuring basic knowledge and abilities, allow different interventions and anatomic variations, minimize the trauma of surgical intervention, and reduce operative casualties. An integrated questionnaire covers instrumentation, fluid infusion, power source, indications and preparation for endometrial ablation, surgical techniques, and complications to evaluate the user's knowledge. The operation simulation then proceeds. In the endometrial cavity, by virtual simulation, the operating field should appear in real time to allow physicians to adapt the trajectory of the instruments. The computer is an IBM PC compatible. We use a modified joystick with optical encoders to know the instrument position. The simulation can be repeated as desired. An evaluation system is integrated in the software to keep the user informed on the amount of burn area(s) that have been completed. This prototype model is available.

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.

Random distributed feedback fibre lasers

Energy Technology Data Exchange (ETDEWEB)

Turitsyn, Sergei K., E-mail: s.k.turitsyn@aston.ac.uk [Aston Institute of Photonic Technologies, Aston University, Birmingham B4 7ET (United Kingdom); Novosibirsk State University, 2 Pirogova str., 630090, Novosibirsk (Russian Federation); Babin, Sergey A. [Novosibirsk State University, 2 Pirogova str., 630090, Novosibirsk (Russian Federation); Institute of Automation and Electrometry SB RAS, 1 Ac. Koptug. ave., 630090, Novosibirsk (Russian Federation); Churkin, Dmitry V. [Aston Institute of Photonic Technologies, Aston University, Birmingham B4 7ET (United Kingdom); Novosibirsk State University, 2 Pirogova str., 630090, Novosibirsk (Russian Federation); Institute of Automation and Electrometry SB RAS, 1 Ac. Koptug. ave., 630090, Novosibirsk (Russian Federation); Vatnik, Ilya D.; Nikulin, Maxim [Institute of Automation and Electrometry SB RAS, 1 Ac. Koptug. ave., 630090, Novosibirsk (Russian Federation); Podivilov, Evgenii V. [Novosibirsk State University, 2 Pirogova str., 630090, Novosibirsk (Russian Federation); Institute of Automation and Electrometry SB RAS, 1 Ac. Koptug. ave., 630090, Novosibirsk (Russian Federation)

2014-09-10

The concept of random lasers exploiting multiple scattering of photons in an amplifying disordered medium in order to generate coherent light without a traditional laser resonator has attracted a great deal of attention in recent years. This research area lies at the interface of the fundamental theory of disordered systems and laser science. The idea was originally proposed in the context of astrophysics in the 1960s by V.S. Letokhov, who studied scattering with “negative absorption” of the interstellar molecular clouds. Research on random lasers has since developed into a mature experimental and theoretical field. A simple design of such lasers would be promising for potential applications. However, in traditional random lasers the properties of the output radiation are typically characterized by complex features in the spatial, spectral and time domains, making them less attractive than standard laser systems in terms of practical applications. Recently, an interesting and novel type of one-dimensional random laser that operates in a conventional telecommunication fibre without any pre-designed resonator mirrors–random distributed feedback fibre laser–was demonstrated. The positive feedback required for laser generation in random fibre lasers is provided by the Rayleigh scattering from the inhomogeneities of the refractive index that are naturally present in silica glass. In the proposed laser concept, the randomly backscattered light is amplified through the Raman effect, providing distributed gain over distances up to 100 km. Although an effective reflection due to the Rayleigh scattering is extremely small (∼0.1%), the lasing threshold may be exceeded when a sufficiently large distributed Raman gain is provided. Such a random distributed feedback fibre laser has a number of interesting and attractive features. The fibre waveguide geometry provides transverse confinement, and effectively one-dimensional random distributed feedback leads to the

Random distributed feedback fibre lasers

International Nuclear Information System (INIS)

Turitsyn, Sergei K.; Babin, Sergey A.; Churkin, Dmitry V.; Vatnik, Ilya D.; Nikulin, Maxim; Podivilov, Evgenii V.

2014-01-01

The concept of random lasers exploiting multiple scattering of photons in an amplifying disordered medium in order to generate coherent light without a traditional laser resonator has attracted a great deal of attention in recent years. This research area lies at the interface of the fundamental theory of disordered systems and laser science. The idea was originally proposed in the context of astrophysics in the 1960s by V.S. Letokhov, who studied scattering with “negative absorption” of the interstellar molecular clouds. Research on random lasers has since developed into a mature experimental and theoretical field. A simple design of such lasers would be promising for potential applications. However, in traditional random lasers the properties of the output radiation are typically characterized by complex features in the spatial, spectral and time domains, making them less attractive than standard laser systems in terms of practical applications. Recently, an interesting and novel type of one-dimensional random laser that operates in a conventional telecommunication fibre without any pre-designed resonator mirrors–random distributed feedback fibre laser–was demonstrated. The positive feedback required for laser generation in random fibre lasers is provided by the Rayleigh scattering from the inhomogeneities of the refractive index that are naturally present in silica glass. In the proposed laser concept, the randomly backscattered light is amplified through the Raman effect, providing distributed gain over distances up to 100 km. Although an effective reflection due to the Rayleigh scattering is extremely small (∼0.1%), the lasing threshold may be exceeded when a sufficiently large distributed Raman gain is provided. Such a random distributed feedback fibre laser has a number of interesting and attractive features. The fibre waveguide geometry provides transverse confinement, and effectively one-dimensional random distributed feedback leads to the

Random coil chemical shifts in acidic 8 M urea: Implementation of random coil shift data in NMRView

International Nuclear Information System (INIS)

Schwarzinger, Stephan; Kroon, Gerard J.A.; Foss, Ted R.; Wright, Peter E.; Dyson, H. Jane

2000-01-01

Studies of proteins unfolded in acid or chemical denaturant can help in unraveling events during the earliest phases of protein folding. In order for meaningful comparisons to be made of residual structure in unfolded states, it is necessary to use random coil chemical shifts that are valid for the experimental system under study. We present a set of random coil chemical shifts obtained for model peptides under experimental conditions used in studies of denatured proteins. This new set, together with previously published data sets, has been incorporated into a software interface for NMRView, allowing selection of the random coil data set that fits the experimental conditions best

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

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.

Tukey g-and-h Random Fields

KAUST Repository

Xu, Ganggang; Genton, Marc G.

2016-01-01

We propose a new class of trans-Gaussian random fields named Tukey g-and-h (TGH) random fields to model non-Gaussian spatial data. The proposed TGH random fields have extremely flexible marginal distributions, possibly skewed and/or heavy-tailed, and, therefore, have a wide range of applications. The special formulation of the TGH random field enables an automatic search for the most suitable transformation for the dataset of interest while estimating model parameters. Asymptotic properties of the maximum likelihood estimator and the probabilistic properties of the TGH random fields are investigated. An efficient estimation procedure, based on maximum approximated likelihood, is proposed and an extreme spatial outlier detection algorithm is formulated. Kriging and probabilistic prediction with TGH random fields are developed along with prediction confidence intervals. The predictive performance of TGH random fields is demonstrated through extensive simulation studies and an application to a dataset of total precipitation in the south east of the United States.

Tukey g-and-h Random Fields

KAUST Repository

Xu, Ganggang

2016-07-15

We propose a new class of trans-Gaussian random fields named Tukey g-and-h (TGH) random fields to model non-Gaussian spatial data. The proposed TGH random fields have extremely flexible marginal distributions, possibly skewed and/or heavy-tailed, and, therefore, have a wide range of applications. The special formulation of the TGH random field enables an automatic search for the most suitable transformation for the dataset of interest while estimating model parameters. Asymptotic properties of the maximum likelihood estimator and the probabilistic properties of the TGH random fields are investigated. An efficient estimation procedure, based on maximum approximated likelihood, is proposed and an extreme spatial outlier detection algorithm is formulated. Kriging and probabilistic prediction with TGH random fields are developed along with prediction confidence intervals. The predictive performance of TGH random fields is demonstrated through extensive simulation studies and an application to a dataset of total precipitation in the south east of the United States.

Solution to random differential equations with boundary conditions

Directory of Open Access Journals (Sweden)

Fairouz Tchier

2017-04-01

Full Text Available We study a family of random differential equations with boundary conditions. Using a random fixed point theorem, we prove an existence theorem that yields a unique random solution.

Random sequential adsorption of cubes

Science.gov (United States)

Cieśla, Michał; Kubala, Piotr

2018-01-01

Random packings built of cubes are studied numerically using a random sequential adsorption algorithm. To compare the obtained results with previous reports, three different models of cube orientation sampling were used. Also, three different cube-cube intersection algorithms were tested to find the most efficient one. The study focuses on the mean saturated packing fraction as well as kinetics of packing growth. Microstructural properties of packings were analyzed using density autocorrelation function.

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...

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

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…

Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls.

NARCIS (Netherlands)

Schmeink, C.E.; Bekkers, R.L.M.; Josefsson, A.; Richardus, J.H.; Berndtsson Blom, K.; David, M.P.; Dobbelaere, K.; Descamps, D.

2011-01-01

BACKGROUND: To evaluate co-administration of GlaxoSmithKline Biologicals' human papillomavirus-16/18 AS04-adjuvanted vaccine (HPV) and hepatitis B vaccine (HepB). METHODS: This was a randomized, controlled, open, multicenter study. Healthy girls, aged 9-15 years, were randomized to receive HPV

A comparison of random walks in dependent random environments

NARCIS (Netherlands)

Scheinhardt, Willem R.W.; Kroese, Dirk

We provide exact computations for the drift of random walks in dependent random environments, including $k$-dependent and moving average environments. We show how the drift can be characterized and evaluated using Perron–Frobenius theory. Comparing random walks in various dependent environments, we

Randomness at the root of things 1: Random walks

Science.gov (United States)

Ogborn, Jon; Collins, Simon; Brown, Mick

2003-09-01

This is the first of a pair of articles about randomness in physics. In this article, we use some variations on the idea of a `random walk' to consider first the path of a particle in Brownian motion, and then the random variation to be expected in radioactive decay. The arguments are set in the context of the general importance of randomness both in physics and in everyday life. We think that the ideas could usefully form part of students' A-level work on random decay and quantum phenomena, as well as being good for their general education. In the second article we offer a novel and simple approach to Poisson sequences.

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

Science.gov (United States)

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

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.

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.

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.

Random Fields

Science.gov (United States)

Vanmarcke, Erik

1983-03-01

Random variation over space and time is one of the few attributes that might safely be predicted as characterizing almost any given complex system. Random fields or "distributed disorder systems" confront astronomers, physicists, geologists, meteorologists, biologists, and other natural scientists. They appear in the artifacts developed by electrical, mechanical, civil, and other engineers. They even underlie the processes of social and economic change. The purpose of this book is to bring together existing and new methodologies of random field theory and indicate how they can be applied to these diverse areas where a "deterministic treatment is inefficient and conventional statistics insufficient." Many new results and methods are included. After outlining the extent and characteristics of the random field approach, the book reviews the classical theory of multidimensional random processes and introduces basic probability concepts and methods in the random field context. It next gives a concise amount of the second-order analysis of homogeneous random fields, in both the space-time domain and the wave number-frequency domain. This is followed by a chapter on spectral moments and related measures of disorder and on level excursions and extremes of Gaussian and related random fields. After developing a new framework of analysis based on local averages of one-, two-, and n-dimensional processes, the book concludes with a chapter discussing ramifications in the important areas of estimation, prediction, and control. The mathematical prerequisite has been held to basic college-level calculus.

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.

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

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.

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

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

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

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

Science.gov (United States)

De La O, Ana L; Martel García, Fernando

2014-09-03

Poor governance and accountability compromise young democracies' efforts to provide public services critical for human development, including water, sanitation, health, and education. Evidence shows that accountability agencies like superior audit institutions can reduce corruption and waste in federal grant programs financing service infrastructure. However, little is know about their effect on compliance with grant reporting and resource allocation requirements, or about the causal mechanisms. This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service infrastructure serving marginalized households. The AUDIT study is a block randomized, controlled, three-arm parallel group exploratory trial. A convenience sample of 5 municipalities in each of 17 states in Mexico (n=85) were block randomized to be audited by federal auditors (n=17), by state auditors (n=17), and a control condition outside the annual program of audits (n=51) in a 1:1:3 ratio. Replicable and verifiable randomization was performed using publicly available lottery numbers. Audited municipalities were included in the national program of audits and received standard audits on their use of federal public service infrastructure grants. Municipalities receiving moderate levels of grant transfers were recruited, as these were outside the auditing sampling frame--and hence audit program--or had negligible probabilities of ever being audited. The primary outcome measures capture compliance with the grant program and markers for the causal mechanisms, including deterrence and information effects. Secondary outcome measure include differences in audit reports across federal and state auditors, and measures like career concerns, political promotions, and political clientelism capturing synergistic effects with municipal accountability systems. The survey firm and research

Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study.

Science.gov (United States)

Dellis, Athanasios E; Papatsoris, Athanasios G; Keeley, Francis X; Bamias, Aristotelis; Deliveliotis, Charalambos; Skolarikos, Andreas A

2017-01-01

To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p tamsulosin or solifenacin expressed significantly lower urinary (p tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.

Chaos and random matrices in supersymmetric SYK

Science.gov (United States)

Hunter-Jones, Nicholas; Liu, Junyu

2018-05-01

We use random matrix theory to explore late-time chaos in supersymmetric quantum mechanical systems. Motivated by the recent study of supersymmetric SYK models and their random matrix classification, we consider the Wishart-Laguerre unitary ensemble and compute the spectral form factors and frame potentials to quantify chaos and randomness. Compared to the Gaussian ensembles, we observe the absence of a dip regime in the form factor and a slower approach to Haar-random dynamics. We find agreement between our random matrix analysis and predictions from the supersymmetric SYK model, and discuss the implications for supersymmetric chaotic systems.

Buspirone Versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study

Directory of Open Access Journals (Sweden)

Shahin Akhondzadeh

2012-11-01

Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of

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...

The MIXMAX random number generator

Science.gov (United States)

Savvidy, Konstantin G.

2015-11-01

In this paper, we study the randomness properties of unimodular matrix random number generators. Under well-known conditions, these discrete-time dynamical systems have the highly desirable K-mixing properties which guarantee high quality random numbers. It is found that some widely used random number generators have poor Kolmogorov entropy and consequently fail in empirical tests of randomness. These tests show that the lowest acceptable value of the Kolmogorov entropy is around 50. Next, we provide a solution to the problem of determining the maximal period of unimodular matrix generators of pseudo-random numbers. We formulate the necessary and sufficient condition to attain the maximum period and present a family of specific generators in the MIXMAX family with superior performance and excellent statistical properties. Finally, we construct three efficient algorithms for operations with the MIXMAX matrix which is a multi-dimensional generalization of the famous cat-map. First, allowing to compute the multiplication by the MIXMAX matrix with O(N) operations. Second, to recursively compute its characteristic polynomial with O(N2) operations, and third, to apply skips of large number of steps S to the sequence in O(N2 log(S)) operations.

Probabilistic Signal Recovery and Random Matrices

Science.gov (United States)

2016-12-08

that classical methods for linear regression (such as Lasso) are applicable for non- linear data. This surprising finding has already found several...we studied the complexity of convex sets. In numerical linear algebra , we analyzed the fastest known randomized approximation algorithm for...and perfect matchings In numerical linear algebra , we studied the fastest known randomized approximation algorithm for computing the permanents of

Solution Methods for Structures with Random Properties Subject to Random Excitation

DEFF Research Database (Denmark)

Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

This paper deals with the lower order statistical moments of the response of structures with random stiffness and random damping properties subject to random excitation. The arising stochastic differential equations (SDE) with random coefficients are solved by two methods, a second order...... the SDE with random coefficients with deterministic initial conditions to an equivalent nonlinear SDE with deterministic coefficient and random initial conditions. In both methods, the statistical moment equations are used. Hierarchy of statistical moments in the markovian approach is closed...... by the cumulant neglect closure method applied at the fourth order level....

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...

Preoperative antibiotic prophylaxis in orthognathic surgery: a randomized, double-blind, and placebo-controlled clinical study

NARCIS (Netherlands)

Zijderveld, S. A.; Smeele, L. E.; Kostense, P. J.; Tuinzing, D. B.

1999-01-01

This study evaluated the need for antibiotic prophylaxis in orthognathic surgery. Fifty-four patients (age range, 18 to 40 years) underwent bimaxillary orthognatic surgery. After randomization, a placebo (n = 19), 2,200 mg amoxicillin-clavulanic acid (n = 18), or 1,500 mg cefuroxime (n = 17) was

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...

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.

The study of combining Latin Hypercube Sampling method and LU decomposition method (LULHS method) for constructing spatial random field

Science.gov (United States)

WANG, P. T.

2015-12-01

Groundwater modeling requires to assign hydrogeological properties to every numerical grid. Due to the lack of detailed information and the inherent spatial heterogeneity, geological properties can be treated as random variables. Hydrogeological property is assumed to be a multivariate distribution with spatial correlations. By sampling random numbers from a given statistical distribution and assigning a value to each grid, a random field for modeling can be completed. Therefore, statistics sampling plays an important role in the efficiency of modeling procedure. Latin Hypercube Sampling (LHS) is a stratified random sampling procedure that provides an efficient way to sample variables from their multivariate distributions. This study combines the the stratified random procedure from LHS and the simulation by using LU decomposition to form LULHS. Both conditional and unconditional simulations of LULHS were develpoed. The simulation efficiency and spatial correlation of LULHS are compared to the other three different simulation methods. The results show that for the conditional simulation and unconditional simulation, LULHS method is more efficient in terms of computational effort. Less realizations are required to achieve the required statistical accuracy and spatial correlation.

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

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

Reserves Represented by Random Walks

International Nuclear Information System (INIS)

Filipe, J A; Ferreira, M A M; Andrade, M

2012-01-01

The reserves problem is studied through models based on Random Walks. Random walks are a classical particular case in the analysis of stochastic processes. They do not appear only to study reserves evolution models. They are also used to build more complex systems and as analysis instruments, in a theoretical feature, of other kind of systems. In this work by studying the reserves, the main objective is to see and guarantee that pensions funds get sustainable. Being the use of these models considering this goal a classical approach in the study of pensions funds, this work concluded about the problematic of reserves. A concrete example is presented.

Random magnetism

International Nuclear Information System (INIS)

Tahir-Kheli, R.A.

1975-01-01

A few simple problems relating to random magnetic systems are presented. Translational symmetry, only on the macroscopic scale, is assumed for these systems. A random set of parameters, on the microscopic scale, for the various regions of these systems is also assumed. A probability distribution for randomness is obeyed. Knowledge of the form of these probability distributions, is assumed in all cases [pt

Moderate alcohol consumption reduces plasma C-reactive protein and fibrinogen levels : a randomized, diet-controlled intervention study

NARCIS (Netherlands)

Sierksma, A.; Gaag, M.S. van der; Kluft, C.; Hendriks, H.F.J.

2002-01-01

Objective: To evaluate the effect of moderate alcohol consumption on the acute phase proteins C-reactive protein and fibrinogen. Design: Randomized, diet-controlled, cross-over study. Setting: The study was performed at TNO Nutrition and Food Research, Zeist, The Netherlands. Subjects: Ten

Outcome of systemic and analytic group psychotherapy for adult women with history of intrafamilial childhood sexual abuse: a randomized controlled study

DEFF Research Database (Denmark)

Lau, M; Kristensen, Ellids

2007-01-01

Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA.......Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA....

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

Random number generation in bilingual Balinese and German students: preliminary findings from an exploratory cross-cultural study.

Science.gov (United States)

Strenge, Hans; Lesmana, Cokorda Bagus Jaya; Suryani, Luh Ketut

2009-08-01

Verbal random number generation is a procedurally simple task to assess executive function and appears ideally suited for the use under diverse settings in cross-cultural research. The objective of this study was to examine ethnic group differences between young adults in Bali (Indonesia) and Kiel (Germany): 50 bilingual healthy students, 30 Balinese and 20 Germans, attempted to generate a random sequence of the digits 1 to 9. In Balinese participants, randomization was done in Balinese (native language L1) and Indonesian (first foreign language L2), in German subjects in the German (L1) and English (L2) languages. 10 of 30 Balinese (33%), but no Germans, were unable to inhibit habitual counting in more than half of the responses. The Balinese produced significantly more nonrandom responses than the Germans with higher rates of counting and significantly less occurrence of the digits 2 and 3 in L1 compared with L2. Repetition and cycling behavior did not differ between the four languages. The findings highlight the importance of taking into account culture-bound psychosocial factors for Balinese individuals when administering and interpreting a random number generation test.

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

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.

Author Details

African Journals Online (AJOL)

Elbareg, AM. Vol 9, No 3 (2014) - Articles Hysteroscopic Endometrial Resection in the Management of Abnormal Uterine Bleeding Among Libyan Women Abstract · Vol 9, No 4 (2014) - Articles Hysteroscopy in Libyan women with Recurrent Pregnancy Loss Abstract. ISSN: 1858-5051. AJOL African Journals Online. HOW TO ...

A randomized, double-blind, placebo-controlled crossover study of ...

African Journals Online (AJOL)

Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, ...

The Effect of Iron Status on Risk of Coronary Artery Disease: A Mendelian Randomization Study-Brief Report.

Science.gov (United States)

Gill, Dipender; Del Greco M, Fabiola; Walker, Ann P; Srai, Surjit K S; Laffan, Michael A; Minelli, Cosetta

2017-09-01

Iron status is a modifiable trait that has been implicated in cardiovascular disease. This study uses the Mendelian randomization technique to investigate whether there is any causal effect of iron status on risk of coronary artery disease (CAD). A 2-sample Mendelian randomization approach is used to estimate the effect of iron status on CAD risk. Three loci (rs1800562 and rs1799945 in the HFE gene and rs855791 in TMPRSS6 ) that are each associated with serum iron, transferrin saturation, ferritin, and transferrin in a pattern suggestive of an association with systemic iron status are used as instruments. SNP (single-nucleotide polymorphism)-iron status association estimates are based on a genome-wide association study meta-analysis of 48 972 individuals. SNP-CAD estimates are derived by combining the results of a genome-wide association study meta-analysis of 60 801 CAD cases and 123 504 controls with those of a meta-analysis of 63 746 CAD cases and 130 681 controls obtained from Metabochip and genome-wide association studies. Combined Mendelian randomization estimates are obtained for each marker by pooling results across the 3 instruments. We find evidence of a protective effect of higher iron status on CAD risk (iron odds ratio, 0.94 per SD unit increase; 95% confidence interval, 0.88-1.00; P =0.039; transferrin saturation odds ratio, 0.95 per SD unit increase; 95% confidence interval, 0.91-0.99; P =0.027; log-transformed ferritin odds ratio, 0.85 per SD unit increase; 95% confidence interval, 0.73-0.98; P =0.024; and transferrin odds ratio, 1.08 per SD unit increase; 95% confidence interval, 1.01-1.16; P =0.034). This Mendelian randomization study supports the hypothesis that higher iron status reduces CAD risk. These findings may highlight a therapeutic target. © 2017 American Heart Association, Inc.

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…

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.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

Science.gov (United States)

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study

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.

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

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.

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

Directory of Open Access Journals (Sweden)

Bernal Daniel DL

2012-04-01

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

Transfundal puncture of a large ovarian cyst with hysteroscopic and ultrasonographic guidance

Directory of Open Access Journals (Sweden)

Zolnierczyk P

2015-05-01

Full Text Available Piotr Zolnierczyk, Krzysztof Cendrowski, Wlodzimierz Sawicki Department of Obstetrics, Gynecology and Oncology, 2nd Faculty of Medicine, Medical University of Warsaw, Warsaw, Poland Abstract: This paper describes the case of an 83-year-old patient with hypertension, diabetes, obesity (body mass index – 38, congestive heart failure, and history of cardiac surgery, who was referred for a diagnostic–therapeutic decompression of a large, symptomatic ovarian cyst. Due to anatomical conditions, the only safe way was a transfundal puncture under mini-hysteroscopic and ultrasound guidance. A puncture with aspiration of 300 mL of serous fluid from the cyst was performed without technical problems and complications. Cytology showed no cancer cells in the examined liquid. Relief from pain and compression discomfort was achieved in the patient. This case shows the possibility of combining ultrasound and minimally invasive diagnostic methods like hysteroscopy in selected clinical situations. Keywords: ovarian cyst puncture, hysteroscopy, ultrasound guided puncture, transfundal cyst puncture, vaginoscopy 

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.

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

Science.gov (United States)

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

2015-03-01

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

Probability, random variables, and random processes theory and signal processing applications

CERN Document Server

Shynk, John J

2012-01-01

Probability, Random Variables, and Random Processes is a comprehensive textbook on probability theory for engineers that provides a more rigorous mathematical framework than is usually encountered in undergraduate courses. It is intended for first-year graduate students who have some familiarity with probability and random variables, though not necessarily of random processes and systems that operate on random signals. It is also appropriate for advanced undergraduate students who have a strong mathematical background. The book has the following features: Several app

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

The Shark Random Swim - (Lévy Flight with Memory)

Science.gov (United States)

Businger, Silvia

2018-05-01

The Elephant Random Walk (ERW), first introduced by Schütz and Trimper (Phys Rev E 70:045101, 2004), is a one-dimensional simple random walk on Z having a memory about the whole past. We study the Shark Random Swim, a random walk with memory about the whole past, whose steps are α -stable distributed with α \\in (0,2] . Our aim in this work is to study the impact of the heavy tailed step distributions on the asymptotic behavior of the random walk. We shall see that, as for the ERW, the asymptotic behavior of the Shark Random Swim depends on its memory parameter p, and that a phase transition can be observed at the critical value p=1/α.

Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Patel Mayur B

2012-09-01

Full Text Available Abstract Background Severe TBI, defined as a Glasgow Coma Scale ≤ 8, increases intracranial pressure and activates the sympathetic nervous system. Sympathetic hyperactivity after TBI manifests as catecholamine excess, hypertension, abnormal heart rate variability, and agitation, and is associated with poor neuropsychological outcome. Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow, brain edema, and agitation. However, there is no prospective randomized evidence available demonstrating the feasibility, outcome benefits, and safety for adrenergic blockade after TBI. Methods/Design The DASH after TBI study is an actively accruing, single-center, randomized, double-blinded, placebo-controlled, two-arm trial, where one group receives centrally acting sympatholytic drugs, propranolol (1 mg intravenously every 6 h for 7 days and clonidine (0.1 mg per tube every 12 h for 7 days, and the other group, double placebo, within 48 h of severe TBI. The study uses a weighted adaptive minimization randomization with categories of age and Marshall head CT classification. Feasibility will be assessed by ability to provide a neuroradiology read for randomization, by treatment contamination, and by treatment compliance. The primary endpoint is reduction in plasma norepinephrine level as measured on day 8. Secondary endpoints include comprehensive plasma and urine catecholamine levels, heart rate variability, arrhythmia occurrence, infections, agitation measures using the Richmond Agitation-Sedation Scale and Agitated Behavior scale, medication use (anti-hypertensive, sedative, analgesic, and antipsychotic, coma-free days, ventilator-free days, length of stay, and mortality. Neuropsychological outcomes will be measured at hospital discharge and at 3 and 12 months. The domains tested will include global executive function, memory, processing speed, visual-spatial, and behavior. Other assessments include

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

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.

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.

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

2016-04-27

Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

Hysteroscopic outpatient metroplasty to expand dysmorphic uteri (HOME-DU technique): a pilot study.

Science.gov (United States)

Di Spiezio Sardo, A; Florio, P; Nazzaro, G; Spinelli, M; Paladini, D; Di Carlo, C; Nappi, C

2015-02-01

The new classification system of uterine anomalies from the European Society of Human Reproduction and Embryology and the European Society for Gynaecological Endoscopy defines T-shaped and tubular-shaped infantilis uteri as 'dysmorphic'. Such malformations have been proven to be associated with poor reproductive performance. A prospective observational study was conducted with 30 infertile women with dysmorphic uterus who underwent the novel Hysteroscopic Outpatient Metroplasty to Expand Dysmorphic Uteri (HOME-DU ) technique. Incisions are made on the uterine walls with a 5 Fr bipolar electrode. The procedure was conducted in outpatients under conscious sedation, using a 5-mm office hysteroscope. The technique was successful in all cases without complications. A net increase of uterine volume was found, as measured at hysteroscopy and three-dimensional transvaginal ultrasound (P dysmorphic uteri. Although the cohort was small, pregnancy and live births outcomes were favourable in this poor-prognosis group, implying desirable benefits, which should be compared with other techniques. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

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

Is magnetotherapy applied to bilateral hips effective in ankylosing spondylitis patients? A randomized, double-blind, controlled study.

Science.gov (United States)

Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas

2014-03-01

This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain.

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

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

A random number generator for continuous random variables

Science.gov (United States)

Guerra, V. M.; Tapia, R. A.; Thompson, J. R.

1972-01-01

A FORTRAN 4 routine is given which may be used to generate random observations of a continuous real valued random variable. Normal distribution of F(x), X, E(akimas), and E(linear) is presented in tabular form.

Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, multi-center study

DEFF Research Database (Denmark)

Gordh, Torsten E; Stubhaug, Audun; Jensen, Troels S

2008-01-01

A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400mg/day. The study comprised a run...

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.

Science.gov (United States)

Crétel-Durand, Elodie; Nouguerède, Emilie; Le Caer, Hervé; Rousseau, Frédérique; Retornaz, Frédérique; Guillem, Olivier; Couderc, Anne-Laure; Greillier, Laurent; Norguet, Emmanuelle; Cécile, Maud; Boulahssass, Rabia; Le Caer, Francoise; Tournier, Sandrine; Butaud, Chantal; Guillet, Pierre; Nahon, Sophie; Poudens, Laure; Kirscher, Sylvie; Loubière, Sandrine; Diaz, Nadine; Dhorne, Jean; Auquier, Pascal; Baumstarck, Karine

2017-04-12

Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy. This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected). The randomized

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

Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

Science.gov (United States)

Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

2018-05-30

To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (pballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

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

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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

Comparative study of random and uniform models for the distribution of TRISO particles in HTR-10 fuel elements

International Nuclear Information System (INIS)

Rosales, J.; Perez, J.; Garcia, C.; Munnoz, A.; Lira, C. A. B. O.

2015-01-01

TRISO particles are the specific features of HTR-10 and generally HTGR reactors. Their heterogeneity and random arrangement in graphite matrix of these reactors create a significant modeling challenge. In the simulation of spherical fuel elements using MCNPX are usually created repetitive structures using uniform distribution models. The use of these repetitive structures introduces two major approaches: the non-randomness of the TRISO particles inside the pebbles and the intersection of the pebble surface with the TRISO particles. These approaches could affect significantly the multiplicative properties of the core. In order to study the influence of these approaches in the multiplicative properties was estimated the K inf value in one pebble with white boundary conditions using 4 different configurations regarding the distribution of the TRISO particles inside the pebble: uniform hexagonal model, cubic uniform model, cubic uniform without the effect of cutting and a random distribution model. It was studied the impact these models on core scale solving the problem B1, from the Benchmark Problems presented in a Coordinated Research Program of the IAEA. (Author)

Randomized Phase III and Extension Studies of Naldemedine in Patients With Opioid-Induced Constipation and Cancer.

Science.gov (United States)

Katakami, Nobuyuki; Harada, Toshiyuki; Murata, Toru; Shinozaki, Katsunori; Tsutsumi, Masakazu; Yokota, Takaaki; Arai, Masatsugu; Tada, Yukio; Narabayashi, Masaru; Boku, Narikazu

2017-12-01

Purpose Opioid-induced constipation (OIC) is a frequent and debilitating adverse effect (AE) of opioids-common analgesics for cancer pain. We investigated the efficacy and safety of a peripherally acting μ-opioid receptor antagonist, naldemedine (S-297995), for OIC, specifically in patients with cancer. Patients and Methods This phase III trial consisted of a 2-week, randomized, double-blind, placebo-controlled study (COMPOSE-4) and an open-label, 12-week extension study (COMPOSE-5). In COMPOSE-4, eligible adults with OIC and cancer were randomly assigned on a 1:1 basis to receive once-daily oral naldemedine 0.2 mg or placebo. The primary end point was the proportion of spontaneous bowel movement (SBM) responders (≥ 3 SBMs/week and an increase of ≥ 1 SBM/week from baseline). The primary end point of COMPOSE-5 was safety. Results In COMPOSE-4, 193 eligible patients were randomly assigned to naldemedine (n = 97) or placebo (n = 96). The proportion of SBM responders in COMPOSE-4 was significantly greater with naldemedine than with placebo (71.1% [69 of 97 patients] v 34.4% [33 of 96 patients]; P opioid withdrawal and had no notable impact on opioid-mediated analgesia. Conclusion Once-daily oral naldemedine 0.2 mg effectively treated OIC and was generally well tolerated in patients with OIC and cancer.

Renal Hemodynamic Effects of Serelaxin in Patients With Chronic Heart Failure A Randomized, Placebo-Controlled Study

NARCIS (Netherlands)

Voors, Adriaan A.; Dahlke, Marion; Meyer, Sven; Stepinska, Janina; Gottlieb, Stephen S.; Jones, Andrew; Zhang, Yiming; Laurent, Didier; Slart, Riemer H. J. A.; Navis, Gerjan J.

2014-01-01

Background-Serelaxin is a promising therapy for acute heart failure. The renal hemodynamic effects of serelaxin in patients with chronic heart failure are unknown. Methods and Results-In this double-blind, randomized, placebo-controlled, multicenter study, patients with New York Heart Association

Projection correlation between two random vectors.

Science.gov (United States)

Zhu, Liping; Xu, Kai; Li, Runze; Zhong, Wei

2017-12-01

We propose the use of projection correlation to characterize dependence between two random vectors. Projection correlation has several appealing properties. It equals zero if and only if the two random vectors are independent, it is not sensitive to the dimensions of the two random vectors, it is invariant with respect to the group of orthogonal transformations, and its estimation is free of tuning parameters and does not require moment conditions on the random vectors. We show that the sample estimate of the projection correction is [Formula: see text]-consistent if the two random vectors are independent and root-[Formula: see text]-consistent otherwise. Monte Carlo simulation studies indicate that the projection correlation has higher power than the distance correlation and the ranks of distances in tests of independence, especially when the dimensions are relatively large or the moment conditions required by the distance correlation are violated.

Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

Science.gov (United States)

Wagler, Amy; Wagler, Ron

2014-01-01

Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

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.

Random numbers spring from alpha decay

International Nuclear Information System (INIS)

Frigerio, N.A.; Sanathanan, L.P.; Morley, M.; Clark, N.A.; Tyler, S.A.

1980-05-01

Congruential random number generators, which are widely used in Monte Carlo simulations, are deficient in that the number they generate are concentrated in a relatively small number of hyperplanes. While this deficiency may not be a limitation in small Monte Carlo studies involving a few variables, it introduces a significant bias in large simulations requiring high resolution. This bias was recognized and assessed during preparations for an accident analysis study of nuclear power plants. This report describes a random number device based on the radioactive decay of alpha particles from a 235 U source in a high-resolution gas proportional counter. The signals were fed to a 4096-channel analyzer and for each channel the frequency of signals registered in a 20,000-microsecond interval was recorded. The parity bits of these frequency counts (0 for an even count and 1 for an odd count) were then assembled in sequence to form 31-bit binary random numbers and transcribed to a magnetic tape. This cycle was repeated as many times as were necessary to create 3 million random numbers. The frequency distribution of counts from the present device conforms to the Brockwell-Moyal distribution, which takes into account the dead time of the counter (both the dead time and decay constant of the underlying Poisson process were estimated). Analysis of the count data and tests of randomness on a sample set of the 31-bit binary numbers indicate that this random number device is a highly reliable source of truly random numbers. Its use is, therefore, recommended in Monte Carlo simulations for which the congruential pseudorandom number generators are found to be inadequate. 6 figures, 5 tables

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.

Ella-V and technology usage technology usage in an english language and literacy acquisition validation randomized controlled trial study

Directory of Open Access Journals (Sweden)

Roisin P. Corcoran

2014-12-01

Full Text Available This paper describes the use of technology to provide virtual professional development (VPD for teachers and to conduct classroom observations in a study of English Language Learner (ELL instruction in grades K–3. The technology applications were part of a cluster randomized control trial (RCT design for a federally funded longitudinal validation study of a particular program, English Language and Literacy Acquisition-Validation, ELLA- V, to determine its degree of impact on English oral language/literacy, reading, and science across 63 randomly assigned urban, suburban, and rural schools (first year of implementation. ELLA-V also examines the impact of bimonthly VPD for treatment teachers compared to comparison group teachers on pedagogical skills, measured by sound observation instruments, and on student achievement, measured by state/national English language/literacy/reading tests and a national science test. This study features extensive technology use via virtual observations, bimonthly VPD, and randomly assigned treatment and control schools with students served in English as second language (ESL instructional time. The study design and methodology are discussed relativeto the specialized uses of technology and issues involving the evaluation of technology’s contribution to the intervention of interest and of the efficient, cost-effective execution of the study.

Critical Properties of Pure and Random Antiferromagnets

DEFF Research Database (Denmark)

Cowley, R. A.; Carneiro, K.

1980-01-01

Neutron scattering techniques have been used to study the critical properties of CoF2 and the randomly mixed systems: Co/ZnF2 and KMn/NiF3. The results for CoF2 are in excellent accord with the critical properties of the three-dimensional Ising model. In all of the random crystals studied the tra...

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

Science.gov (United States)

Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

2013-08-19

Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

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

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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.

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

Directory of Open Access Journals (Sweden)

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.

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

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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.

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

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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.

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

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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.

Long-term effect of physical activity counseling on mobility limitation among older people: a randomized controlled study

DEFF Research Database (Denmark)

Mänty, Minna Regina; Heinonen, Ari; Leinonen, Raija

2009-01-01

counseling-induced benefits persist after cessation of the intervention. METHODS: In a 2-year, single-blinded, randomized controlled study, 632 sedentary participants aged 75-81 years were randomly assigned into the intervention (n = 318) or control (n = 314) group. The intervention group received a single......BACKGROUND: Physical activity counseling increases physical activity among older people, but its effectiveness on mobility, that is, maintaining the ability to move independently, is unknown. We studied the effect of physical activity counseling on mobility among older people and evaluated whether...... individualized physical activity counseling session with a supportive telephone contact every 4 months for 2 years. The outcome measures-perceived difficulty in advanced (walking 2 km) and basic (walking 0.5 km) mobility-were gathered semiannually during the intervention and the 1.5-year postintervention follow...

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

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.

Language-specific strategy for programming hearing aids - A double-blind randomized controlled crossover study.

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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

The Effects of Improvisational Music Therapy on Joint Attention Behaviors in Autistic Children: A Randomized Controlled Study

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Kim, Jinah; Wigram, Tony; Gold, Christian

2008-01-01

The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy and play sessions with toys, and using standardized…

On a randomly imperfect spherical cap pressurized by a random ...

African Journals Online (AJOL)

In this paper, we investigate a dynamical system in a random setting of dual randomness in space and time variables in which both the imperfection of the structure and the load function are considered random , each with a statistical zero-mean .The auto- covariance of the load is correlated as an exponentially decaying ...

Risk Factors for Perioperative Complications in Endoscopic Surgery with Irrigation

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João Manoel Silva, Jr.

2013-07-01

Full Text Available Background and objectives: Currently, endoscopic medicine is being increasingly used, albeit not without risks. Therefore, this study evaluated the factors associated with perioperative complications in endoscopic surgery with intraoperative irrigation. Method: A cohort study of six months duration. Patients aged ≥ 18 years undergoing endoscopic surgery with the use of irrigation fluids during the intraoperative period were included. Exclusion criteria were: use of diuretics, kidney failure, cognitive impairment, hyponatremia prior to surgery, pregnancy, and critically ill. The patients who presented with or without complications during the perioperative period were allocated into two groups. Complications evaluated were related to neurological, cardiovascular and renal changes, and perioperative bleeding. Results: In total, 181 patients were enrolled and 39 excluded; therefore, 142 patients met the study criteria. Patients with complications amounted to 21.8%, with higher prevalence in endoscopic prostate surgery, followed by hysteroscopy, bladder, knee, and shoulder arthroscopy (58.1%, 36.9%, 19.4%, 3.8%, 3.2% respectively. When comparing both groups, we found association with complications in univariate analysis: age, sex, smoking, heart disease, ASA, serum sodium at the end of surgery, total irrigation fluid administered, TURP, and hysteroscopy. However, in multiple regression analysis for complications, only age (OR = 1.048, serum sodium (OR = 0.962, and volume of irrigation fluid administered during surgery (OR = 1.001 were independent variables. Keywords: Anesthesia, Endoscopy, Hyponatremia, Postoperative Complications, Risk Assessment, Risk Factors.

[Hysteroscopic fallopian tube sterilization procedure: feasibility and one-year follow-up].

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Gibon, E; Lopès, P; Linet, T; Martigny, H; Orieux, C; Philippe, H-J

2006-03-01

Hysteroscopic flexible micro-insert (Essure) is an ambulatory improvement of fallopian tube sterilization, which is a deliberated suppression of fertility. The aim of this study was an evaluation of feasibility (learning curve) and the first year outcome of this method. This prospective study, carried out between February 2002 and March 2003, included patients who were matching with manufacturer recommendations. One surgeon only realized all the device placements. Fifty patients were included (one year follow-up). Mean age was 41 (+/-3.3), mean parity was 2.7 (+/-0.8). Mean time needed for device placement was 26 minutes (+/-6.5) and was reduced with increased experience. Six failures of placement (12%) were related, because of submucus leiomyomas, proximal tubal stenotic disease or too retroverted uterus. Only 5 patients (11,4%) described intensive pelvic pain during the placement. The only case of device expulsion benefited from a successful second placement. The one-year follow-up showed no significant difference of body weight increasing, duration or quantity of menstruation, neither significant pelvic pain nor vaginal bleeding. Tolerance was rated at least at "somewhat satisfied". There have been no pregnancies reported in 670 woman-months of effectiveness. Our results agree in any point with those of larger studies. We think that hysteroscopy micro-insert placement is not only reserved to specialized centers but also to any gynecologist who is used to performing hysteroscopy because of its feasibility.

Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

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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

A facility specialist model for improving retention of nursing home staff: results from a randomized, controlled study.

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Pillemer, Karl; Meador, Rhoda; Henderson, Charles; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

2008-07-01

This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and Connecticut and randomly assigned to treatment and control conditions. Staff outcomes were measured through certified nursing assistant interviews, and turnover rates were measured over the course of the year. In the intervention condition, a staff member was selected to be the facility retention specialist, who would advocate for and implement programs to improve staff retention and commitment throughout the facility. Retention specialists received an intensive 3-day training in retention leadership and in a number of evidence-based retention programs. Ongoing support was provided throughout the project. Treatment facilities experienced significant declines in turnover rates compared to control facilities. As predicted, we found positive effects on certified nursing assistant assessments of the quality of retention efforts and of care provided in the facility; we did not find effects for job satisfaction or stress. The study provides evidence for the effectiveness of the retention specialist model. Findings from a detailed process evaluation suggest modifications of the program that may increase program effects.

Random lasing actions in self-assembled perovskite nanoparticles

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Liu, Shuai; Sun, Wenzhao; Li, Jiankai; Gu, Zhiyuan; Wang, Kaiyang; Xiao, Shumin; Song, Qinghai

2016-05-01

Solution-based perovskite nanoparticles have been intensively studied in the past few years due to their applications in both photovoltaic and optoelectronic devices. Here, based on the common ground between solution-based perovskite and random lasers, we have studied the mirrorless lasing actions in self-assembled perovskite nanoparticles. After synthesis from a solution, discrete lasing peaks have been observed from optically pumped perovskites without any well-defined cavity boundaries. We have demonstrated that the origin of the random lasing emissions is the scattering between the nanostructures in the perovskite microplates. The obtained quality (Q) factors and thresholds of random lasers are around 500 and 60 μJ/cm2, respectively. Both values are comparable to the conventional perovskite microdisk lasers with polygon-shaped cavity boundaries. From the corresponding studies on laser spectra and fluorescence microscope images, the lasing actions are considered random lasers that are generated by strong multiple scattering in random gain media. In additional to conventional single-photon excitation, due to the strong nonlinear effects of perovskites, two-photon pumped random lasers have also been demonstrated for the first time. We believe this research will find its potential applications in low-cost coherent light sources and biomedical detection.

The effect of endometrial scratch on natural-cycle cryopreserved embryo transfer outcomes: a randomized controlled study.

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Mak, Jennifer Sze Man; Chung, Cathy Hoi Sze; Chung, Jacqueline Pui Wah; Kong, Grace Wing Shan; Saravelos, Sotirios H; Cheung, Lai Ping; Li, Tin-Chiu

2017-07-01

The benefit of endometrial scratch (ES) prior to embryo transfer is controversial. Systemic analysis has confirmed its potential benefit, especially in women with repeated IVF failures, yet most studies have focused on fresh embryo transfer, and its effect on vitrified-warmed embryo transfer (FET) cycles is yet to be explored. We hereby present our prospective, double-blind, randomized controlled study on the evaluation of the implantation and pregnancy rate after ES prior to natural-cycle FET. A total of 299 patients underwent natural-cycle FET and were randomized to receive ES (n = 115) or endocervical manipulation as control (n = 114) prior to FET cycle, and a total of 196 patients had embryo transfer (93 patients in each group). Our study showed no significant difference in the implantation and pregnancy rate, as well as the clinical and ongoing pregnancy or live birth rates between the two groups. It appears that ES does not have any beneficial effect on an unselected group of women undergoing FET in natural cycles. Further studies on its effect in women with recurrent implantation failure after IVF are warranted. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

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.

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

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

Directory of Open Access Journals (Sweden)

Jimin Park

2015-01-01

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

Miglustat in late-onset Tay-Sachs disease: a 12-month, randomized, controlled clinical study with 24 months of extended treatment.

Science.gov (United States)

Shapiro, Barbara E; Pastores, Gregory M; Gianutsos, John; Luzy, Cécile; Kolodny, Edwin H

2009-06-01

To evaluate the safety and efficacy of miglustat in patients with GM2 gangliosidosis. A randomized, multicenter, open-label, 12-month study involving patients aged 18 years or older, randomized 2:1 to miglustat (200 mg TID) or "no miglustat treatment." This study was followed by 24 months of extended treatment during which all patients received miglustat. Primary efficacy endpoints were change in eight measures of isometric muscle strength in the limbs and isometric grip strength, evaluated at baseline, and months 12 and 36. Secondary efficacy endpoints included gait, balance, disability, and other neurological assessments. Safety evaluations included adverse event reporting. Thirty patients (67% male, age range 18-56 years) with late-onset Tay-Sachs disease were enrolled; 20 were randomized to miglustat and 10 to "no miglustat treatment." Muscle and grip strength generally decreased over the study period. No differences were observed between the two groups in any efficacy measure, either during the 12-month randomized phase or the full 36 months. The most common treatment-related adverse events were decrease in weight and diarrhea. Miglustat treatment was not shown to lead to measurable benefits in this cohort of patients with late-onset Tay-Sachs disease. The observed safety profile was consistent with that of the approved dose (100 mg TID) in type 1 Gaucher disease.

Fundamentals of randomized clinical trials in wound care

DEFF Research Database (Denmark)

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

2012-01-01

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

Topological properties of random wireless networks

Indian Academy of Sciences (India)

Wireless networks in which the node locations are random are best modelled as random geometric graphs (RGGs). In addition to their extensive application in the modelling of wireless networks, RGGs find many new applications and are being studied in their own right. In this paper we first provide a brief introduction to the ...

Intrinsic intensity fluctuations in random lasers

International Nuclear Information System (INIS)

Molen, Karen L. van der; Mosk, Allard P.; Lagendijk, Ad

2006-01-01

We present a quantitative experimental and theoretical study of intensity fluctuations in the emitted light of a random laser that has different realizations of disorder for every pump pulse. A model that clarifies these intrinsic fluctuations is developed. We describe the output versus input power graphs of the random laser with an effective spontaneous emission factor (β factor)

Effects of random study checks and guided notes study cards on middle school special education students' notetaking accuracy and science vocabulary quiz scores

Science.gov (United States)

Wood, Charles L.

Federal legislation mandates that all students with disabilities have meaningful access to the general education curriculum and that students with and without disabilities be held equally accountable to the same academic standards (IDEIA, 2004; NCLB, 2001). Many students with disabilities, however, perform poorly in academic content courses, especially at the middle and secondary school levels. Previous research has reported increased notetaking accuracy and quiz scores over lecture content when students completed guided notes compared to taking their own notes. This study evaluated the effects of a pre-quiz review procedure and specially formatted guided notes on middle school special education students' learning of science vocabulary. This study compared the effects of three experimental conditions. (a) Own Notes (ON), (b) Own Notes+Random Study Checks (ON+RSC), and (c) Guided Notes Study Cards+Random Study Checks (GNSC+RSC) on each student's accuracy of notes, next-day quiz scores, and review quiz scores. Each session, the teacher presented 12 science vocabulary terms and definitions during a lecture and students took notes. The students were given 5 minutes to study their notes at the end of each session and were reminded to study their notes at home and in study hall period. In the ON condition students took notes on a sheet of paper with numbered lines from 1 to 12. Just before each next-day quiz in the ON+RSC condition students used write-on response cards to answer two teacher-posed questions over randomly selected vocabulary terms from the previous day's lecture. If the answer on a randomly selected student's response card was correct, that student earned a lottery ticket for inexpensive prizes and a quiz bonus point for herself and each classmate. In the GNSC+RSC condition students took notes on specially formatted guided notes that after the lecture they cut into a set of flashcards that could used for study. The students' mean notetaking accuracy was 75

Random matrix ensembles with random interactions: Results for ...

Indian Academy of Sciences (India)

... Public Lectures · Lecture Workshops · Refresher Courses · Symposia · Live Streaming. Home; Journals; Pramana – Journal of Physics; Volume 73; Issue 3. Random matrix ensembles with random interactions: Results for EGUE(2)-(4). Manan Vyas Manan Vyas. Volume 73 Issue 3 September 2009 pp 521-531 ...

Random Intercept and Random Slope 2-Level Multilevel Models

Directory of Open Access Journals (Sweden)

Rehan Ahmad Khan

2012-11-01

Full Text Available Random intercept model and random intercept & random slope model carrying two-levels of hierarchy in the population are presented and compared with the traditional regression approach. The impact of students’ satisfaction on their grade point average (GPA was explored with and without controlling teachers influence. The variation at level-1 can be controlled by introducing the higher levels of hierarchy in the model. The fanny movement of the fitted lines proves variation of student grades around teachers.

Coupled continuous time-random walks in quenched random environment

Science.gov (United States)

Magdziarz, M.; Szczotka, W.

2018-02-01

We introduce a coupled continuous-time random walk with coupling which is characteristic for Lévy walks. Additionally we assume that the walker moves in a quenched random environment, i.e. the site disorder at each lattice point is fixed in time. We analyze the scaling limit of such a random walk. We show that for large times the behaviour of the analyzed process is exactly the same as in the case of uncoupled quenched trap model for Lévy flights.

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

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.

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.

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.

Caffeine improves endurance in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study

DEFF Research Database (Denmark)

Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk

2005-01-01

This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... and were randomized to receive one capsule of placebo and then caffeine (6 mg/kg) or caffeine and then placebo with 1 wk in between. One hour after intervention, we measured reaction and movement times, postural stability, walking speed, cycling at 65% of expected maximal heart rate, perceived effort...... during cycling, maximal isometric arm flexion strength, and endurance. Analysis was by intention to treat, and P Caffeine increased cycling endurance by 25% [95% confidence interval (CI): 13–38; P = 0.0001] and isometric arm flexion endurance by 54% (95% CI: 29–83; P...

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

Science.gov (United States)

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

2011-06-01

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

Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study.

Science.gov (United States)

Sankhe, A; Dalal, K; Save, D; Sarve, P

2017-12-01

The present study was conducted to assess the effect of spiritual care in patients with depression, anxiety or both in a randomized controlled design. The participants were randomized either to receive spiritual care or not and Hamilton anxiety rating scale-A (HAM-A), Hamilton depression rating scale-D (HAM-D), WHO-quality of life-Brief (WHOQOL-BREF) and Functional assessment of chronic illness therapy - Spiritual well-being (FACIT-Sp) were assessed before therapy and two follow-ups at 3 and 6 week. However, with regard to the spiritual care therapy group, statistically significant differences were observed in both HAM-A and HAM-D scales between the baseline and visit 2 (p scales during the follow-up periods for the control group of participants. When the scores were compared between the study groups, HAM-A, HAM-D and FACIT-Sp 12 scores were significantly lower in the interventional group as compared to the control group at both third and sixth weeks. This suggests a significant improvement in symptoms of anxiety and depression in the spiritual care therapy group than the control group; however, large randomized controlled trials with robust design are needed to confirm the same.

Designing the selenium and bladder cancer trial (SELEBLAT, a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

Directory of Open Access Journals (Sweden)

Goossens Maria E

2012-03-01

Full Text Available Abstract Background In Belgium, bladder cancer is the fifth most common cancer in males (5.2% and the sixth most frequent cause of death from cancer in males (3.8%. Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence. Method The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. Patients are randomly assigned to selenium yeast (200 μg/day supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study. Design The SELEnium and BLAdder cancer Trial (SELEBLAT is a phase III randomized, placebo-controlled, academic, double-blind superior trial. Discussion This is the first report on a selenium randomized trial in bladder cancer patients. Trial registration ClinicalTrials.gov identifier: NCT00729287

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...

Linking of uniform random polygons in confined spaces

International Nuclear Information System (INIS)

Arsuaga, J; Blackstone, T; Diao, Y; Karadayi, E; Saito, M

2007-01-01

In this paper, we study the topological entanglement of uniform random polygons in a confined space. We derive the formula for the mean squared linking number of such polygons. For a fixed simple closed curve in the confined space, we rigorously show that the linking probability between this curve and a uniform random polygon of n vertices is at least 1-O(1/√n). Our numerical study also indicates that the linking probability between two uniform random polygons (in a confined space), of m and n vertices respectively, is bounded below by 1-O(1/√(mn)). In particular, the linking probability between two uniform random polygons, both of n vertices, is bounded below by 1-O(1/n)

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

Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

Science.gov (United States)

Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

2015-08-28

Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

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

Ultrasound-Guided Out-of-Plane vs. In-Plane Interscalene Catheters: A Randomized, Prospective Study

OpenAIRE

Schwenk, Eric S.; Gandhi, Kishor; Baratta, Jaime L.; Torjman, Marc; Epstein, Richard H.; Chung, Jaeyoon; Vaghari, Benjamin A.; Beausang, David; Bojaxhi, Elird; Grady, Bernadette

2015-01-01

Background: Continuous interscalene blocks provide excellent analgesia after shoulder surgery. Although the safety of the ultrasound-guided in-plane approach has been touted, technical and patient factors can limit this approach. We developed a caudad-to-cephalad out-of-plane approach and hypothesized that it would decrease pain ratings due to better catheter alignment with the brachial plexus compared to the in-plane technique in a randomized, controlled study. Objectives: To compare an out-...

Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

OpenAIRE

Weinblatt, Michael E.; Baranauskaite, Asta; Niebrzydowski, Jaroslaw; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz‐Rosiak, Krystyna; Cheong, Soo Yeon; Ghil, Jeehoon; Sokolovic, S.; Mekic, M.; Prodanovic, N.; Gajic, B.

2017-01-01

Objective SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). Methods In this phase III, randomized, double‐blind, parallel‐group study, patients with moderately to severely active RA despite treatment with methotrexate were randomized 1:1 to receive SB5 or reference ADA at a dosage of 40 mg subcutaneously every o...

Random diffusion and leverage effect in financial markets.

Science.gov (United States)

Perelló, Josep; Masoliver, Jaume

2003-03-01

We prove that Brownian market models with random diffusion coefficients provide an exact measure of the leverage effect [J-P. Bouchaud et al., Phys. Rev. Lett. 87, 228701 (2001)]. This empirical fact asserts that past returns are anticorrelated with future diffusion coefficient. Several models with random diffusion have been suggested but without a quantitative study of the leverage effect. Our analysis lets us to fully estimate all parameters involved and allows a deeper study of correlated random diffusion models that may have practical implications for many aspects of financial markets.

Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials.

Science.gov (United States)

Berman, Anne H; Gajecki, Mikael; Fredriksson, Morgan; Sinadinovic, Kristina; Andersson, Claes

2015-12-22

About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish

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.

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

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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.

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.

The groupies of random multipartite graphs

OpenAIRE

Portmann, Marius; Wang, Hongyun

2012-01-01

If a vertex $v$ in a graph $G$ has degree larger than the average of the degrees of its neighbors, we call it a groupie in $G$. In the current work, we study the behavior of groupie in random multipartite graphs with the link probability between sets of nodes fixed. Our results extend the previous ones on random (bipartite) graphs.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

Science.gov (United States)

Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

2014-11-25

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature

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.

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

Science.gov (United States)

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy

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)

Generating equilateral random polygons in confinement III

International Nuclear Information System (INIS)

Diao, Y; Ernst, C; Montemayor, A; Ziegler, U

2012-01-01

In this paper we continue our earlier studies (Diao et al 2011 J. Phys. A: Math. Theor. 44 405202, Diao et al J. Phys. A: Math. Theor. 45 275203) on the generation methods of random equilateral polygons confined in a sphere. The first half of this paper is concerned with the generation of confined equilateral random walks. We show that if the selection of a vertex is uniform subject to the position of its previous vertex and the confining condition, then the distributions of the vertices are not uniform, although there exists a distribution such that if the initial vertex is selected following this distribution, then all vertices of the random walk follow this same distribution. Thus in order to generate a confined equilateral random walk, the selection of a vertex cannot be uniform subject to the position of its previous vertex and the confining condition. We provide a simple algorithm capable of generating confined equilateral random walks whose vertex distribution is almost uniform in the confinement sphere. In the second half of this paper we show that any process generating confined equilateral random walks can be turned into a process generating confined equilateral random polygons with the property that the vertex distribution of the polygons approaches the vertex distribution of the walks as the polygons get longer and longer. In our earlier studies, the starting point of the confined polygon is fixed at the center of the sphere. The new approach here allows us to move the starting point of the confined polygon off the center of the sphere. (paper)

The physics of randomness and regularities for languages (lifetimes, family trees, and the second languages); in terms of random matrices

OpenAIRE

Tuncay, Caglar

2007-01-01

The physics of randomness and regularities for languages (mother tongues) and their lifetimes and family trees and for the second languages are studied in terms of two opposite processes; random multiplicative noise [1], and fragmentation [2], where the original model is given in the matrix format. We start with a random initial world, and come out with the regularities, which mimic various empirical data [3] for the present languages.

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...

Essure: a revolution in female definitive contraception

Directory of Open Access Journals (Sweden)

Daniella de Batista Depes

2009-09-01

Full Text Available Tubal sterilization is the most widely used procedure in the world for definitive contraception. It is safely performed by laparoscopy, but it is an invasive procedure with potential surgical and anesthetic risks. By hysteroscopy, the Essure micro-insert assures tubal obstruction with no need of hospitalization, incision or anesthesia.

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.

Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

Directory of Open Access Journals (Sweden)

Vickers Andrew J