WorldWideScience

Sample records for trial comparing gluteal

  1. Acute gluteal compartment syndrome: superior gluteal artery rupture following a low energy injury.

    Science.gov (United States)

    Smith, Aubrey; Chitre, Vivek; Deo, Hersh

    2012-12-17

    Acute compartment syndrome affecting the gluteal region is rare when compared to the same condition in the forearm or calf. When it does occur, it is usually due to prolonged immobilisation in those with altered consciousness. Gluteal compartment syndrome resulting from injury to the superior gluteal artery is extremely rare and to our knowledge has been described only twice--both after high-energy road traffic accidents (RTA). Other cases have described profound hypotension with superior gluteal artery injury after an RTA and falling off a horse, without acute gluteal compartment syndrome. We present a case of gluteal compartment syndrome due to rupture of the superior gluteal artery following a relatively minor fall. The patient required an emergency fasciotomy, which was performed within 4 h of the injury. This case highlights the importance of early diagnosis and treatment of this rare condition.

  2. Acetabular anteversion is associated with gluteal tendinopathy at MRI

    Energy Technology Data Exchange (ETDEWEB)

    Moulton, Kyle M. [University of Saskatchewan, Department of Medical Imaging, Saskatoon, SK (Canada); Royal University Hospital, Department of Medical Imaging, Saskatoon, SK (Canada); Aly, Abdel-Rahman [University of Saskatchewan, Department of Physical Medicine and Rehabilitation, Saskatoon, SK (Canada); Rajasekaran, Sathish [Health Pointe - Pain, Spine and Sport Medicine, Edmonton, AB (Canada); Shepel, Michael; Obaid, Haron [University of Saskatchewan, Department of Medical Imaging, Saskatoon, SK (Canada)

    2015-01-15

    Gluteal tendinopathy and greater trochanteric pain syndrome (GTPS) remain incompletely understood despite their pervasiveness in clinical practice. To date, no study has analyzed the morphometric characteristics of the hip on magnetic resonance imaging (MRI) that may predispose to gluteal tendinopathy. This study aimed to evaluate whether acetabular anteversion (AA), femoral neck anteversion (FNA), and femoral neck-shaft angle (FNSA) are associated with MRI features of gluteal tendinopathy. A total of 203 MRI examinations of the hip met our inclusion and exclusion criteria. A single blinded investigator measured AA, FNA, and FNSA according to validated MRI techniques. Two blinded subspecialty-trained musculoskeletal radiologists then independently evaluated the presence of gluteal tendinosis, trochanteric bursitis, and subgluteal bursitis. Statistical analysis was performed using a one-way analysis of variance (ANOVA; post-hoc Tukey's range test). At MRI, 57 patients had gluteal tendinosis with or without bursitis, 26 had isolated trochanteric bursitis, and 11 had isolated subgluteal bursitis. AA was significantly (p = 0.01) increased in patients with MRI evidence of gluteal tendinosis with or without bursitis [mean: 18.4 , 95 % confidence interval (CI): 17.2 -19.6 ] compared with normal controls (mean: 15.7 , 95 % CI: 14.7 -16.8 ). Similarly, AA was significantly (p = 0.04) increased in patients with isolated trochanteric bursitis (mean: 18.8 , 95 % CI: 16.2 -21.6 ). No association was found between FNA or FNSA and the presence of gluteal tendinopathy. Interobserver agreement for the presence and categorization of gluteal tendinopathy was very good (kappa = 0.859, 95 % CI: 0.815-0.903). Our MRI study suggests that there is an association between increased AA and gluteal tendinopathy, which supports a growing body of evidence implicating abnormal biomechanics in the development of this condition. (orig.)

  3. Acetabular anteversion is associated with gluteal tendinopathy at MRI

    International Nuclear Information System (INIS)

    Moulton, Kyle M.; Aly, Abdel-Rahman; Rajasekaran, Sathish; Shepel, Michael; Obaid, Haron

    2015-01-01

    Gluteal tendinopathy and greater trochanteric pain syndrome (GTPS) remain incompletely understood despite their pervasiveness in clinical practice. To date, no study has analyzed the morphometric characteristics of the hip on magnetic resonance imaging (MRI) that may predispose to gluteal tendinopathy. This study aimed to evaluate whether acetabular anteversion (AA), femoral neck anteversion (FNA), and femoral neck-shaft angle (FNSA) are associated with MRI features of gluteal tendinopathy. A total of 203 MRI examinations of the hip met our inclusion and exclusion criteria. A single blinded investigator measured AA, FNA, and FNSA according to validated MRI techniques. Two blinded subspecialty-trained musculoskeletal radiologists then independently evaluated the presence of gluteal tendinosis, trochanteric bursitis, and subgluteal bursitis. Statistical analysis was performed using a one-way analysis of variance (ANOVA; post-hoc Tukey's range test). At MRI, 57 patients had gluteal tendinosis with or without bursitis, 26 had isolated trochanteric bursitis, and 11 had isolated subgluteal bursitis. AA was significantly (p = 0.01) increased in patients with MRI evidence of gluteal tendinosis with or without bursitis [mean: 18.4 , 95 % confidence interval (CI): 17.2 -19.6 ] compared with normal controls (mean: 15.7 , 95 % CI: 14.7 -16.8 ). Similarly, AA was significantly (p = 0.04) increased in patients with isolated trochanteric bursitis (mean: 18.8 , 95 % CI: 16.2 -21.6 ). No association was found between FNA or FNSA and the presence of gluteal tendinopathy. Interobserver agreement for the presence and categorization of gluteal tendinopathy was very good (kappa = 0.859, 95 % CI: 0.815-0.903). Our MRI study suggests that there is an association between increased AA and gluteal tendinopathy, which supports a growing body of evidence implicating abnormal biomechanics in the development of this condition. (orig.)

  4. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  5. Comparison of gluteal perforator flaps and gluteal fasciocutaneous rotation flaps for reconstruction of sacral pressure sores.

    Science.gov (United States)

    Chen, Yen-Chou; Huang, Eng-Yen; Lin, Pao-Yuan

    2014-03-01

    The gluteus maximus myocutaneous flap was considered the workhorse that reconstructed sacral pressure sores, but was gradually replaced by fasciocutaneous flap because of several disadvantages. With the advent of the perforator flap technique, gluteal perforator (GP) flap has gained popularity nowadays. The aim of this study was to compare the complications and outcomes between GP flaps and gluteal fasciocutaneous rotation (FR) flaps in the treatment of sacral pressure sores. Between April 2007 and June 2012, 63 patients underwent sacral pressure sore reconstructions, with a GP flap used in 31 cases and an FR flap used in 32 cases. Data collected on the patients included patient age, gender, co-morbidity for being bedridden and follow-up time. Surgical details collected included the defect size, operative time and estimated blood loss. Complications recorded included re-operation, dehiscence, flap necrosis, wound infection, sinus formation, donor-site morbidity and recurrence. The complications and clinical outcomes were compared between these two groups. We found that there was no significant difference in patient demographics, surgical complications and recurrence between these two groups. In gluteal FR flap group, all recurrent cases (five) were treated by reuse of previous flaps. Both methods are comparable, good and safe in treating sacral pressure sores. Gluteal FR flap can be performed without microsurgical dissection, and re-rotation is feasible in recurrent cases. The authors suggest using gluteal FR flaps in patients with a high risk of sore recurrence. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  6. Arthroscopic release using F and C method versus conventional open release method in the treatment of gluteal muscle contracture: a comparative study.

    Science.gov (United States)

    Rai, Saroj; Jin, Shengyang; Meng, Chunqing; Chaudhary, Nabin; Tamang, Nira; Wang, Xiaohong; Liu, Xianzhe; Wang, Hong; Yang, Shuhua

    2017-03-16

    Gluteal muscle contracture (GMC), a debilitating disease, usually starts in early childhood after variable dose of injections around the buttock, if left untreated it worsens gradually and persists throughout the life. Because the disease mostly affects adolescents and adults, there is always an aesthetic concerns. Purposeof the study was to introduce the arthroscopic F and C method of GMC release, and to compare its clinical efficiency with conventional open surgery in terms of clinical outcome, rate of complications, patient's satisfactions, and recurrence. Between Jan 2013 and July 2015, 75 patients received an arthroscopic release with F and C release method and 71 patients received conventional open release of GMC. Primary surgeries in 16 years or older patients were included in the study. Two groups were compared clinically using Hip Outcome Scores - Activities of Daily Living Subscale (HOS-ADL), Hip Outcome Scores - Sports Subscale (HOS-Sports), Visual Analogue Scale (VAS), and Ye et al. evaluation criteria. No statistically significant differences were observed in Hip Outcome Scores - Activities of Daily Living Subscale (HOS-ADL) (P = 0.078), Hip Outcome Scores - Sports Subscale (HOS-Sports) (P = 0.340), and Visual Analogue Scale (VAS) (P = 0.524) between the two groups. 74 (98.7%) patients in the arthroscopic surgery group had good to excellent results, whereas 69 (97.1%) patients in the conventional open surgery group had good to excellent results (P = 0.727). No statistically significant difference was observed in recurrence rate (P = 0.612). Statistically significant differences were observed in incision length, use of post-operative analgesia, post-operative off-bed activity, and hospital stay. Complications were significantly higher in the conventional open surgery group (n = 21) than in the arthroscopic surgery group (n = 10) (P = 0.016). More importantly, cosmetic satisfaction was 100% in arthroscopic release group

  7. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  8. The relationship between hamstring length and gluteal muscle strength in individuals with sacroiliac joint dysfunction.

    Science.gov (United States)

    Massoud Arab, Amir; Reza Nourbakhsh, Mohammad; Mohammadifar, Ali

    2011-02-01

    It has been suggested that tight hamstring muscle, due to its anatomical connections, could be a compensatory mechanism for providing sacroiliac (SI) joint stability in patients with gluteal muscle weakness and SIJ dysfunction. The purpose of this study was to determine the relationship between hamstring muscle length and gluteal muscle strength in subjects with sacroiliac joint dysfunction. A total of 159 subjects with and without low back pain (LBP) between the ages of 20 and 65 years participate in the study. Subjects were categorized into three groups: LBP without SIJ involvement (n = 53); back pain with SIJ dysfunction (n = 53); and no low back pain (n = 53). Hamstring muscle length and gluteal muscle strength were measured in all subjects. The number of individuals with gluteal weakness was significantly (P = 0.02) higher in subjects with SI joint dysfunction (66%) compared to those with LBP without SI joint dysfunctions (34%). In pooled data, there was no significant difference (P = 0.31) in hamstring muscle length between subjects with SI joint dysfunction and those with back pain without SI involvement. In subjects with SI joint dysfunction, however, those with gluteal muscle weakness had significantly (P = 0.02) shorter hamstring muscle length (mean = 158±11°) compared to individuals without gluteal weakness (mean = 165±10°). There was no statistically significant difference (P>0.05) in hamstring muscle length between individuals with and without gluteal muscle weakness in other groups. In conclusion, hamstring tightness in subjects with SI joint dysfunction could be related to gluteal muscle weakness. The slight difference in hamstring muscle length found in this study, although statistically significant, was not sufficient for making any definite conclusions. Further studies are needed to establish the role of hamstring muscle in SI joint stability.

  9. Computed tomographic measurement of gluteal subcutaneous fat thickness in reference to failure of gluteal intramuscular injections

    Energy Technology Data Exchange (ETDEWEB)

    Burbridge, B.E. [Univ. of Saskatchewan, Royal Univ. Hospital, Academic Dept. of Medical Imaging, Saskatoon, Saskatchewan (Canada)]. E-mail: brent.burbridge@usask.ca

    2007-04-15

    Casual observation of gluteal region fat thickness on computed tomography (CT) of the pelvis leads to the hypothesis that, in some individuals intended intramuscular injections are not properly deposited in the gluteal muscle. We gathered and analyzed data to determine whether this hypothesis was true. CT scans of the pelvis were analyzed over an 18-day period in the tall of 2005. The thickness of gluteal region subcutaneous fat was measured in a standardized manner. Measurement of gluteal region subcutaneous fat thickness was performed for 298 pelvic CT scans. There were 150 male subjects and 148 female subjects. The average gluteal fat thickness for female subjects was 33.2 mm, whereas the average for male subjects was 23.1 mm. Analysis revealed a significant difference in gluteal region fat thickness between male and female subjects. A 37-mm needle, allowing for 6-mm penetration of the gluteal muscle, would not have entered the gluteal muscle fibres in 81 of 148 female subjects (54.7%), in 21 of 150 male subjects (14%), and in 102 of the 298 total sample (34.2%). Analysis revealed a significant difference between male and female subjects with regard to gluteal muscle needle penetration. An overall predicted failure rate of 34% was identified for intended gluteal intramuscular injections when the standard technique was used. This is important information for care providers who inject medications in the gluteal region. In a significant number of patients, the medications will be injected subcutaneously and not into the gluteal musculature, possibly altering the pharmacokinetics of the administered medication. An alternative injection site should probably be chosen to increase the success rate of intramuscular deposition of medications and vaccines in unselected adults. (author)

  10. Fatal Complications of Aesthetic Techniques: The Gluteal Region.

    Science.gov (United States)

    Rapkiewicz, Amy V; Kenerson, Katherine; Hutchins, Kenneth D; Garavan, Fintan; Lew, Emma O; Shuman, Mark J

    2018-02-21

    Cosmetic procedures are common and utilize many techniques to obtain aesthetically good outcomes for patient satisfaction with acceptable safety standards. Cosmetic procedures that involve the gluteal region are becoming increasingly popular as various procedures can target the gluteal region such as liposuction, tumescent liposuction, cosmetic filler injections, autologous fat transfer, depot drug delivery, and implants. Complications of cosmetic gluteal procedures can be localized or systemic with systemic complications being responsible for most deaths. These reported systemic complications include sepsis, thromboembolism, fat embolism with or without fat embolism syndrome, macroscopic fat embolism, anesthesia-related and blood volume abnormalities. We herein report 10 deaths due to elective gluteal cosmetic procedures. Autologous fat transfer (fat grafting, lipoinjection) following liposuction resulted in 8 of 10 fatal outcomes of the gluteal aesthetic procedures. A comprehensive discussion of gluteal anatomy, gluteal contouring procedures, and the approach to such cases is presented along with the autopsy findings of the reported cases. © 2018 American Academy of Forensic Sciences.

  11. Bilateral gluteal abscesses and myofibrosis complicating ...

    African Journals Online (AJOL)

    BACKGROUND: There is paucity of reports on the musculoskeletal complications of pentazocine abuse in Nigeria.The aim was to report a case of bilateral gluteal abscesses and myofibrosis as a consequence of parenteral pentazocine abuse. CASE SUMMARY: We report a case of a 39 year old housewife who presented ...

  12. Roles of TGF-β/Smad signaling pathway in pathogenesis and development of gluteal muscle contracture.

    Science.gov (United States)

    Zhang, Xintao; Ma, Yukun; You, Tian; Tian, Xiaopeng; Zhang, Honglei; Zhu, Qi; Zhang, Wentao

    2015-02-01

    Gluteal muscle contracture (GMC) is a chronic fibrotic disease of gluteal muscles which is characterized by excessive deposition of collagen in the extracellular matrix. Transforming growth factor (TGF)-βs have been shown to play an important role in the progression of GMC. However, the underlying mechanisms are not entirely clear. We sought to explore the expression of TGF-β/Smad pathway proteins and their downstream targets in gluteal muscle contracture disease. The expression levels of collagens type I/III, TGF-β1, Smad2/3/4/7 and PAI-1 (plasminogen activator inhibitor type 1) in gluteal muscle contraction (GMC) patients were measured using immunohistochemistry, reverse transcription and polymerase chain reaction (RT-PCR) and western blot assays. The expressions of collagens type I/III and TGF-β1 were significantly increased in the contraction band compared with unaffected muscle. In addition, R-Smad phosphorylation and Smad4 protein expression in the contraction band were also elevated, while the expression of Smad7 was significantly decreased in the fibrotic muscle of the GMC patients compared to the unaffected adjacent muscle. The protein and mRNA levels of PAI-1 were also remarkably increased in the contraction band compared with adjacent muscle. Immunohistochemical analysis also demonstrated that the expression levels of TGF-β1 and PAI-1 were higher in contraction band than those in the adjacent muscle. Our data confirm the stimulating effects of the TGF-β/Smad pathway in gluteal muscle contracture disease and reveal the internal changes of TGF-β/Smad pathway proteins and their corresponding targets in gluteal muscle contracture patients.

  13. Duplication of Inferior Gluteal Artery and Course of Superior Gluteal Artery Through the Lumbosacral Trunk

    Directory of Open Access Journals (Sweden)

    Satheesha Nayak B

    2017-07-01

    Full Text Available Internal iliac artery (IIA shows great deal of variations in its branching pattern. The knowledge of its variant branches is required for successful surgical, orthopedic, plastic surgery and radiological procedures. We observed variations of some of the branches of right IIA in an adult male cadaver. The iliolumbar artery originated from the main trunk of the IIA. After this, IIA divided into anterior and posterior divisions. The posterior division gave lateral sacral and superior gluteal arteries. Superior gluteal artery pierced the lumbosacral trunk before leaving the pelvis. The anterior division further divided into anterior and posterior trunks. Anterior trunk gave rise to superior vesical, inferior vesical, middle rectal and obturator arteries. The posterior trunk gave two inferior gluteal arteries and an internal pudendal artery.

  14. [Etiological analysis and significance of anterior knee pain induced by gluteal muscles contracture].

    Science.gov (United States)

    Zhao, Gang; Liu, Yu-jie; Wang, Jun-liang; Qi, Wei; Qu, Feng; Yuan, Bang-tuo; Wang, Jiang-tao; Shen, Xue-zhen; Liu, Yang; Zhu, Juan-li

    2014-12-01

    To explore causes of gluteal muscle contracture induced anterior knee pain and curative effect of arthroscopic release. From March 2002 to August 2013,36 patients with gluteal muscle contracture induced anterior knee pain were treated, including 15 males, 21 females, aged from 9 to 40 years old with an average (18.7±7.2) years old; the courses of diseases ranged from 4 to 30 years. The clinical manifestations involved limited to symmelia, positive Ober sign, buttocks touch contracture belts, knee and patella slide to lateral when doing squat activities. All patients were performed gluteal muscle contracture release under arthroscopic. Postoperative complications were observed, Kujala scoring before and after operation was used for compare curative effect. All patients were followed up with an average of 29 months. The incision were healed well, and no complications were occurred. Postoperative Kujala score were improved more than preoperative. Gluteal muscle contracture release could alleviate hypertension of lateral patella, and palys an important role in preventing patellofemoral arthritis.

  15. Ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock: Case report

    Directory of Open Access Journals (Sweden)

    Kerem Seref Corbacioglu

    2016-03-01

    Full Text Available Pseudoaneurysm of the superior gluteal artery (SGA is very rare and the most common causes are blunt or penetrating pelvic traumas. Although pseudoaneurysm can be asymptomatic at the time of initial trauma, it can be symptomatic weeks, months, even years after initial trauma. We present a case of a ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock twenty days after a bomb injury in the Syria civil war. In addition, we review the anatomy of the SGA, clinical presentation and pitfalls of pseudoaneurysm, and imaging and treatment options. Keywords: Pseudoaneurysm, Superior gluteal artery, Pitfall, Angiography

  16. [Gluteal muscle contracture release for the treatment of gluteal muscle contracture induced knee osteoarthritis: a report of 52 cases].

    Science.gov (United States)

    Wang, Cheng-xiang; Gong, Yu-suo; Li, Sheng-hua; Liu, Hai-ping; Chai, Xi-ping

    2011-07-01

    To investigate clinical efficacy and significance of gluteal muscle contracture release for the treatment of gluteal muscle contracture induced knee osteoarthritis. From January 2008 to June 2010,52 patients with gluteal muscle contracture induced knee osteoarthritis were reviewed. Among the patients,15 patients were male and 37 patients were female, ranging in age from 15 to 45 years, with an average of 35 years. Eighteen patients had left knee osteoarthritis, 30 patients had right osteoarthritis, and 4 patients had double knee osteoarthritis. All the patients were treated with gluteal muscle contracture release. Lysholm knee score was used to evaluate therapeutic effects before and after operation. All the patients were followed up,and the duration ranged from 12 to 37 years,with a mean of 15 months. The Lysholm knee score improved from preoperative (68.12 +/- 0.78) points to postoperative (91.23 +/- 0.47) points at the last follow-up, the difference had statistical difference (t=31.269, Pmuscle contracture release is effective to relieve symptoms of gluteal muscles contracture and knee osteoarthritis. The patients with gluteal muscle contracture should be treated early so as to prevent effects of gluteal muscle contracture on knee joint, slow down degeneration of knee joint at early stage, and prevent occurrence of knee osteoarthritis.

  17. BUILDING A BETTER GLUTEAL BRIDGE: ELECTROMYOGRAPHIC ANALYSIS OF HIP MUSCLE ACTIVITY DURING MODIFIED SINGLE-LEG BRIDGES.

    Science.gov (United States)

    Lehecka, B J; Edwards, Michael; Haverkamp, Ryan; Martin, Lani; Porter, Kambry; Thach, Kailey; Sack, Richard J; Hakansson, Nils A

    2017-08-01

    Gluteal strength plays a role in injury prevention, normal gait patterns, eliminating pain, and enhancing athletic performance. Research shows high gluteal muscle activity during a single-leg bridge compared to other gluteal strengthening exercises; however, prior studies have primarily measured muscle activity with the active lower extremity starting in 90 ° of knee flexion with an extended contralateral knee. This standard position has caused reports of hamstring cramping, which may impede optimal gluteal strengthening. The purpose of this study was to determine which modified position for the single-leg bridge is best for preferentially activating the gluteus maximus and medius. Cross-Sectional. Twenty-eight healthy males and females aged 18-30 years were tested in five different, randomized single-leg bridge positions. Electromyography (EMG) electrodes were placed on subjects' gluteus maximus, gluteus medius, rectus femoris, and biceps femoris of their bridge leg (i.e., dominant or kicking leg), as well as the rectus femoris of their contralateral leg. Subjects performed a maximal voluntary isometric contraction (MVIC) for each tested muscle prior to performing five different bridge positions in randomized order. All bridge EMG data were normalized to the corresponding muscle MVIC data. A modified bridge position with the knee of the bridge leg flexed to 135 ° versus the traditional 90 ° of knee flexion demonstrated preferential activation of the gluteus maximus and gluteus medius compared to the traditional single-leg bridge. Hamstring activation significantly decreased (p bridge by flexing the active knee to 135 ° instead of 90 ° minimizes hamstring activity while maintaining high levels of gluteal activation, effectively building a bridge better suited for preferential gluteal activation. 3.

  18. Gluteal fat thickness in pelvic CT

    International Nuclear Information System (INIS)

    Park, Jeong Mi; Jung, Se Young; Lee, Jae Mun; Park, Seog Hee; Kim, Choon Yul; Bahk, Yong Whee

    1986-01-01

    Many calcifications due to fat necrosis in the buttocks detected on the pelvis roentgenograms suggest that the majority of injections intended to be intramuscular actually are delivered into fat. We measured thickness of adult gluteal fat to decide whether the injection using needle of usual length is done into fat or muscle. We measured the vertical thickness of the subcutaneous fat at a point of 2-3cm above the femoral head cut slice with randomly collected 116 cases of adults in the department of Radiology, St. Mary's Hospital, Catholic Medical College. We found that 32% female cases might actually receive on intra adipose injection when a needle of maximum 3.8cm length is inserted into the buttock. If deposition into muscle is desirable, we need to choose needle whose length is appropriate for the site of injection and the patient's deposits of fat.

  19. Gluteal muscle fibrosis with abduction contracture of the hip.

    Science.gov (United States)

    Al Bayati, Mohammed Ali; Kraidy, Bakir Kadhum

    2016-03-01

    Gluteal muscle fibrosis with hip contracture is a rare condition and causes major disability; literature reports are sparse. The aim of this study is to present, for the first time in Iraq and the region, a case series of gluteal fibrosis and the results of surgical treatment. Seven children--six boys and one girl--diagnosed as having gluteal muscle fibrosis with hip contracture, were investigated and treated by open surgical release of fibrotic bands and physiotherapy. All patients improved dramatically over the subsequent weeks, and were able to sit and squat in the normal position. Gluteal muscle fibrosis with hip contracture is present in Iraq and more awareness is needed for early diagnosis. Surgical treatment provided excellent results. More studies are needed to delineate the aetiology of the condition.

  20. Pseudoaneurysm of the superior gluteal artery following polytrauma

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Dennis [Vancouver General Hospital, University of British Columbia and Department of Radiology, Vancouver, BC (Canada); Legiehn, Gerald M. [Vancouver General Hospital, Interventional Radiology, University of British Columbia and Department of Radiology, Vancouver, BC (Canada); Munk, Peter L. [Vancouver General Hospital, MSK Section, University of British Columbia and Department of Radiology, Vancouver, BC (Canada)

    2007-09-15

    Gluteal artery aneurysms are rare and often secondary to pelvic fractures, blunt or penetrating trauma. We describe a case of a superior gluteal artery pseudoaneurysm that presented as back pain with numbness and weakness of the lower extremities. Diagnosis was confirmed by color Doppler sonography and angiography. A proximal and distal control was obtained over the aneurysm neck via coil embolization with excellent hemostasis within the pseudoaneurysm and maintenance of perfusion to the left pelvis. (orig.)

  1. Pseudoaneurysm of the superior gluteal artery following polytrauma

    International Nuclear Information System (INIS)

    Lee, Dennis; Legiehn, Gerald M.; Munk, Peter L.

    2007-01-01

    Gluteal artery aneurysms are rare and often secondary to pelvic fractures, blunt or penetrating trauma. We describe a case of a superior gluteal artery pseudoaneurysm that presented as back pain with numbness and weakness of the lower extremities. Diagnosis was confirmed by color Doppler sonography and angiography. A proximal and distal control was obtained over the aneurysm neck via coil embolization with excellent hemostasis within the pseudoaneurysm and maintenance of perfusion to the left pelvis. (orig.)

  2. CT diagnosis of gluteal muscle contracture in children

    International Nuclear Information System (INIS)

    Wang Longsheng; Bao Jiaqi; Pan Zhili; Hu Kefei; Jiang Jiatan; Zhang Hongliang; Sun Jun; Yuan Yi

    2004-01-01

    Objective: To investigate the CT manifestations of gluteal muscle contracture (GMC) in children. Methods: Sixty-one cases of GMC diagnosed by CT and proved by surgery and pathology were studied with 20 cases of non-GMC as the control group. Results: 57 cases (93.4%) were bilateral contracture and 4 cases (6.6%) were unilateral contracture in 61 cases of GMC; The main CT manifestations were as follows: (1) gluteal muscle volume shrunk. There were 118 (100.0%) sides of gluteus maximus contracture , 16 ( 13.6 %) sides of gluteus medius contracture , 12 ( 10.2 %) sides of piriformis contracture, 4 (3.4%) sides of gluteus minimus contracture, 4 (3.4%) sides of capsula articularis contracture; (2) calcification and necrosis in injection zones. There were 95 (80.5%) sides of gluteal calcification and 24 (20.3%) sides of gluteal necrosis; (3) stripe crispation fascia. There were 81 stripes crispation fascia located outboard laterals of gluteus maximus, 36 located inboard laterals of the latter; (4) gluteal muscle clearance widened. There were 38 (32.2%) sides of light degree gluteal muscle contracture, 53 (44.9%) sides of middle degree, and 27 (22.9%) sides of heavy degree. Conclusion: CT can accurately diagnose GMC and it plays an important role in the evaluation of pathological extent and degree of GMC

  3. Child gluteal aggressive fibromatosis: a correlative study of CT findings and pathology

    International Nuclear Information System (INIS)

    Fan Miao; Li Ziping; Meng Quanfei; Guo Yan; Ye Bingbing; Xiao Gang

    2005-01-01

    Objective: To evaluate CT imaging in the diagnosis of child gluteal aggressive fibromatosis. Methods: CT manifestations of child gluteal aggressive fibromatosis were retrospectively analyzed. In total 7 males and 1 female, 2 to 11 years old, were enrolled in study. All cases had been confirmed by surgery and pathology. CT findings were correlatively studied with pathology. Results: Lesions located on the left side were noted in 7 cases, and a lesion located on right side was seen in the rest 1 cam The lesions were elliptical or lobulated on CT images. Three tumors originated from solitary muscle and multiple muscles were involved in other 5 cases. Tumors were well demarcated. Invasion to the adjacent structure was shown in 7 cases. All tumors were homogeneous in density in non-enhanced scan. Compared to the muscles in the same section, 5 tumors were iso -density and 3 tumors were hypo-density. Inside the lesions no hemorrhage, necrosis, cystic degeneration and calcification was revealed. After contrast medium was administrated, iso-dense and homogeneous enhancement as the adjacent muscles was seen in 1 tumor and apparent enhancement were demonstrated in 7 tumors. Seven tumors tended to grow along the longitudinal axis of muscles and infiltrated into fascial space. Atrophy resulting from compression was shown in the adjacent muscles in 6 cases. The major clinical manifestation was limp. Gluteal aggressive fibromatosis was confirmed by pathology in all cases. Conclusion: There are characteristics of child gluteal aggressive fibromatosis in age of onset, gender of the patients, site of the lesion and CT findings as well. CT manifestations were consistent with pathology. CT imaging is helpful in initial diagnosis and differential diagnosis, as well as in assessing the expansion of the tumor and involvement of the adjacent structures. (authors)

  4. [Diagnosis and treatment of unilateral gluteal muscle contracture].

    Science.gov (United States)

    Chen, Xiaoliang; Tang, Xueyang; Jiang, Xin; Wang, Daoxi; Peng, Mingxing; Liu, Lijun

    2011-05-01

    To investigate the pathogenesis, diagnosis, and treatment of unilateral gluteal muscle contracture. Between January 1990 and September 2009, 41 patients with unilateral gluteal muscle contracture were treated and the clinical data were retrospectively analysed. Among them, 24 were male and 17 were female with an age range from 6 to 29 years (mean, 12 years). Thirty-nine patients had a definite history of repeat intragluteal injection. The locations were the left side in 9 cases and the right side in 32 cases. The main clinical manifestations included lameness and abnormal gait. The medical examination showed pelvic oblique and relative inequality of lower limbs with a mean difference of 2.1 cm (range, 1.2-3.8 cm) in the distance form navel to malleolus medials. The X-ray films of pelvis showed outpouching trochanter of femur and pelvic oblique. The CT scans showed no abnormal finding except pelvic oblique and gluteal muscle contracture. The arc longitudinal incision was made into the posterolateral area nearby the greater trochanter and then lysis of the gluteal muscles was performed, followed by the skin traction of both legs and rehabilitation exercise. All incisions healed by first intention. Forty-one patients were followed up 1-20 years (mean, 5 years), and the signs of gluteal muscle contracture disappeared. After 1 year of operation, 34 patients had equal leg length, 5 patients had mild pelvic oblique, and 2 patients had obvious pelvic oblique. According to LIU Guohui et al. evaluation standard, the results were excellent in 33 cases, good in 6 cases, and poor in 2 cases with an excellent and good rate of 95.12% at 1 year after operation. Unilateral gluteal muscle contracture leads to pelvic oblique and inequality of lower limbs, and it can be cured with the surgical release of the gluteal muscle contracture by the arc longitudinal incision into the posterolateral area nearby the greater trochanter, combined with postoperative skin traction and

  5. Gluteal muscle contracture: diagnosis and management options

    Science.gov (United States)

    Rai, Saroj; Meng, Chunqing; Wang, Xiaohong; Chaudhary, Nabin; Jin, Shengyang; Yang, Shuhua; Wang, Hong

    2017-01-01

    Gluteal muscle contracture (GMC), a debilitating disease, exists all over the globe but it is much more prevalent in China. Patients typically present with abduction and external rotation of the hip and are unable to bring both the knees together while squatting. Multiple etiologies have been postulated, the commonest being repeated intramuscular injection into the buttocks. The disease is diagnosed primarily by clinical features but radiological features are necessary for the exclusion of other pathological conditions. Non-operative treatment with physiotherapy can be tried before surgery is considered but it usually fails. Different surgical techniques have been described and claimed to have a better outcome of one over another but controversy still exists. Based on published literatures, the clinical outcome is exceptionally good in all established methods of surgery. However, endoscopic surgery is superior to conventional open surgery in terms of cosmetic outcome with fewer complications. Nevertheless, its use has been limited by lack of adequate knowledge, instrumentations, and some inherent limitations. Above all, post-operative rehabilitation plays a key role in better outcome, which however should be started gradually. PMID:28059055

  6. The application of MRI in gluteal muscle contracture

    International Nuclear Information System (INIS)

    Zhao Tao; You Yuhua; Sun Jing; Cheng Kebin; Liu Wei; Qu Hui

    2003-01-01

    Objective: To evaluate the MRI findings and its diagnostic value in gluteal muscle contracture (GMC). Methods: Eleven clinic or operation confirmed GMC patients were examined by plain X-ray and MRI. Conventional T 1 WI and T 2 WI MR imaging were performed and FFE-T 2 WI (fast field echo-T 2 WI) was also scanned. CT scan was conducted in 5 cases. Results: 11 GMC patients were all diagnosed by MRI. Conventional T 1 WI and T 2 WI could only show the atrophy of gluteal muscles, while FFE-T 2 WI could directly show the fibrous band of gluteal muscle and its fascia, and the fibrous band appeared as low signal intensity on FFE-T 2 WI sequence. Conclusions: MRI is the efficient modality in imaging the fibrous band for GMC patients, and FFE-T 2 WI is the most valuable sequence. MRI is very helpful in the diagnosis and treatment of GMC

  7. [Insertion of gluteus maximus tendo-chilles lengthening with Z-shaped for the treatment of severe gluteal muscle contracture].

    Science.gov (United States)

    Chen, Huan-shi; Yang, Xiao-long

    2015-06-01

    To investigate clinical curative effects of gluteal muscle contracture release combined with insertion of gluteus maximus tendo-chilles lengthening with Z-shaped in treating severe gluteal muscles contracture. From 2006 May to 2011 May, 20 patients (35 sides) with severe gluteal muscle contracture were collected, including 12 males and 8 females, aged from 8 to 34 years old with an average of 13 years old; the courses of disease ranged from 3 to 21 years. All patients manifested abnormal gait at different degree, knees close together cannot squat,positive syndrome of Ober, positive test of alice leg. Gluteus contracture fascia release were performed firstly in operation, then insertion of tendo-chilles lengthening with Z-shaped were carried out. Preoperative and postoperative gait, and knee flexion hip extensor squat test, cross leg test, adduction and internal rotary activity of hip joint, stretch strength and motor ability after hip abduction were observed and compared. Twenty patients were followed up for 1 to 5 years. Gluteus maximus were released thoroughly, and snapping hip was disappeared, Ober syndrome were negative. There was significant differences in knee flexion hip extensor squat test, adduction and internal rotary activity of hip joint,stretch before and after operation (Pmuscle strength was protected,stretch strength and motor ability of hip joint were recovered well. Among them,31 cases got excellent results and 4 good. For severe gluteal muscles contracture,insertion of gluteus maximus tendo-chilles lengthening with Z-shaped performed after gluteus contracture fascia release could release gluteal muscle contracture to the greatest extent and obtain postoperative curative effect without resection of normal hip muscle fibers and destroy joint capsule.

  8. Ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock: Case report.

    Science.gov (United States)

    Corbacioglu, Kerem Seref; Aksel, Gokhan; Yildiz, Altan

    2016-03-01

    Pseudoaneurysm of the superior gluteal artery (SGA) is very rare and the most common causes are blunt or penetrating pelvic traumas. Although pseudoaneurysm can be asymptomatic at the time of initial trauma, it can be symptomatic weeks, months, even years after initial trauma. We present a case of a ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock twenty days after a bomb injury in the Syria civil war. In addition, we review the anatomy of the SGA, clinical presentation and pitfalls of pseudoaneurysm, and imaging and treatment options.

  9. Evaluation of the Superior Gluteal Nerve During Proximal Femoral Nailing

    Directory of Open Access Journals (Sweden)

    Mehmet Sonmez

    2017-05-01

    Full Text Available Aim: The superior gluteal nerve may be compromised during hip surgery. We retrospectively evaluated the patients who underwent proximal femoral nailing for unstable trochanteric fractures in order to investigate the presence of superior gluteal nerve injury and its clinical findings. Material and Method: Twenty five patients (14 women, 11 men were included in the study who had femoral nailing between January 2004 and March 2010 at Hamidiye Sisli Etfal Training and Research Hospital Department of Orthopaedics. Two different types of nails which have similar designs and surgical techniques were used for fracture fixation. Patients who had a history of cerebrovascular disease, electromyography findings of polyneuropathy, or degenerative vertebral disease were excluded from the study. Patients were evaluated clinically and radiologically. Findings related to acute denervation in the gluteus medius muscle and motor unit action potential changes were accepted as signs of superior gluteal nerve injury. Results: Eight patients were using support during walking and three of these patients had positive Trendelenburg sign, but only one patient had acute denervation signs of the superior gluteal nerve. Discussion: Based on the present study the incidence of iatrogenic nerve injury is a rare complication of proximal femoral nailing. Elderly patients, regardless of whether they have nerve injury, may limp and need to use a walking support.

  10. Are nursing students safe when choosing gluteal intramuscular injection locations?

    Science.gov (United States)

    Cornwall, J

    2011-01-01

    Nurses are required to perform gluteal intramuscular (IM) injections in practice. There are dangers associated with erroneous performance of this task, particularly with dorsogluteal injections. Knowledge regarding safe injection practice is therefore vital for nursing students. Fifty-eight second year students at a New Zealand Nursing School were given schematic drawings of the posterior and lateral aspects of the gluteal region. They were asked to mark and justify the safest location for gluteal IM injections. Fifty-seven students marked the dorsal schematic and one the lateral, with 38 (66.7%) marking in the upper outer quadrant (UOQ). Twenty indicating the UOQ (52.6%) wrote 'sciatic' or 'nerve' in justifying their location. Nineteen (33.3%) marked a location outside the UOQ; nine (47.4%) of these mentioned 'sciatic' or 'nerve' as reasons for injection safety. Overall, 50% of students mentioned 'sciatic' or 'nerve' in justifying the safety of their chosen injection location. Results suggest some second year nursing students do not understand safe gluteal IM injection locations and rationale. Current teaching practices and IM injection techniques could be revisited to prepare students more effectively; this may help prevent pathologies arising from this procedure.

  11. Gluteal tendinopathy and hip osteoarthritis: Different pathologies, different hip biomechanics.

    Science.gov (United States)

    Allison, Kim; Hall, Michelle; Hodges, Paul W; Wrigley, Tim V; Vicenzino, Bill; Pua, Yong-Hao; Metcalf, Ben; Grimaldi, Alison; Bennell, Kim L

    2018-03-01

    Gluteal tendinopathy (GT) and hip osteoarthritis (OA) are the most common causes of hip pain and associated disability in older adults. Pain and altered walking biomechanics are common to both conditions. This study aimed to compare three-dimensional walking biomechanics between individuals with unilateral, symptomatic GT and HOA. Sixty individuals with symptomatic unilateral GT confirmed by magnetic-resonance-imaging and 73 individuals with symptomatic unilateral HOA (Kellgren-Lawrence Grade ≥ 2) underwent three-dimensional gait analysis. Maximum and minimum values of the external sagittal hip moment, the first peak, second peak and mid-stance minimum of the hip adduction moment (HAM), sagittal plane hip excursion and hip joint angles, pelvic obliquity and trunk lean, at the three HAM time points during stance phase of walking were compared between groups. Compared to individuals with HOA, those with GT exhibited a greater hip peak extension moment (P < 0.001) and greater HAM throughout the stance phase of walking (P = 0.01-P < 0.001), greater hip adduction (P < 0.001) and internal rotation (P < 0.01-P < 0.001) angles and lower hip flexion angles and excursion (P = 0.02 - P < 0.001). Individuals with HOA exhibited a greater forward trunk lean (P ≤ 0.001) throughout stance, and greater ipsilateral trunk lean in the frontal plane (P < 0.001) than those with GT. Despite presence of pain in both conditions, hip kinematics and kinetics differ between individuals with symptomatic unilateral GT and those with symptomatic unilateral HOA. These condition-specific impairments may be targets for optimization of management of HOA and GT. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. Muscle-splitting approach to superior and inferior gluteal vessels: versatile source of recipient vessels for free-tissue transfer to sacral, gluteal, and ischial regions.

    Science.gov (United States)

    Park, S

    2000-07-01

    The superior gluteal vessel has been reported as a recipient in free-tissue transfer for the coverage of complex soft-tissue defects in the lumbosacral region, where a suitable recipient vessel is difficult to find. The characteristics of proximity, vessel caliber, and constancy make the superior gluteal vessel preferable to previously reported recipient vessels. However, there are technical difficulties in microsurgery (e.g., short pedicle length and deep location) and muscle injury (transection of the muscle) associated with use of the superior gluteal vessel. The purpose of this article is to present a modification of an approach to the gluteal vessel to alleviate technical difficulties and minimize muscle injury. From August of 1997 to January of 1999, six patients received microvascular transfer of the latissimus dorsi muscle or myocutaneous flap to the sacral (4) and ischial (2) regions. The causes of defects were tumor (1), trauma (1), and pressure sores (4). A muscle-splitting approach was used on the superior gluteal vessel and was later applied to the inferior gluteal vessel. The gluteus maximus muscle was split as needed in the direction of its fibers, and the perforators were dissected down to the superior or inferior gluteal artery and vein deep into the muscle. The follow-up period ranged from 6 to 22 months, and all of the flaps survived with complete recovery of the lesion. The major drawbacks of using the superior and inferior gluteal vessels can be overcome with the muscle-splitting approach, which provides increased accessibility and additional length to the vascular pedicle while causing minimal injury to the muscle itself. It also proves to be an easy, safe, and reliable method of dissection. When free-tissue transfer to sacral, gluteal, and ischial regions is indicated, the muscle-splitting approach to the superior and inferior gluteal vessels is a recommended option in the selection of a recipient vessel.

  13. Prolonged electrical stimulation-induced gluteal and hamstring muscle activation and sitting pressure in spinal cord injury: Effect of duty cycle

    NARCIS (Netherlands)

    MSc Karin J.A. Legemate; MD Christof A. J. Smit; MSc Anja de Koning; PhD Sonja de Groot; MD, PhD Janneke M. Stolwijk-Swuste; PhD Thomas W.H. Janssen

    2013-01-01

    Abstract—Pressure ulcers (PUs) are highly prevalent in people with spinal cord injury (SCI). Electrical stimulation (ES) activates muscles and might reduce risk factors. Our objectives were to study and compare the effects of two duty cycles during 3 h of ES-induced gluteal and hamstring activation

  14. Prolonged electrical stimulation-induced gluteal and hamstring muscle activation and sitting pressure in spinal cord injury : Effect of duty cycle

    NARCIS (Netherlands)

    Smit, Christof A. J.; Legemate, Karin J. A.; de Koning, Anja; de Groot, Sonja; Stolwijk-Swuste, Janneke M.; Janssen, Thomas W. J.

    2013-01-01

    Pressure ulcers (PUs) are highly prevalent in people with spinal cord injury (SCI). Electrical stimulation (ES) activates muscles and might reduce risk factors. Our objectives were to study and compare the effects of two duty cycles during 3 h of ES-induced gluteal and hamstring activation on

  15. Sedentary lifestyle related exosomal release of Hotair from gluteal-femoral fat promotes intestinal cell proliferation

    OpenAIRE

    Xiaozhao Lu; Danna Bai; Xiangwei Liu; Chen Zhou; Guodong Yang

    2017-01-01

    Pioneering epidemiological work has established strong association of sedentary lifestyle and obesity with the risk of colorectal cancer, while the detailed underlying mechanism remains unknown. Here we show that Hotair (HOX transcript antisense RNA) is a pro-adipogenic long non-coding RNA highly expressed in gluteal-femoral fat over other fat depots. Hotair knockout in adipose tissue results in gluteal-femoral fat defect. Squeeze of the gluteal-femoral fat induces intestinal proliferation in...

  16. Z-plasty for severe gluteal muscle contracture in children.

    Science.gov (United States)

    Zha, Kun; Liu, GuoHui; Yang, Shuhua; Cao, Faqi

    2016-12-01

    To review the records of 363 patients with severe gluteal muscle contracture to determine its mechanism, underlying pathology, and treatment outcome. Records of 136 males and 227 females aged 5 to 18 (mean, 12.2) years who underwent Z-plasty for bilateral (n=347) or unilateral (n=16) severe gluteal muscle contracture were reviewed. Severe gluteal muscle contracture was classified as typical (n=52) or special (n=311). The typical type is associated with symptoms of positive out-toe gait, Ober sign, back-extending test, cross-leg test, squatting with knee side-by-side test, and hip dysfunction. It is further subdivided into mild (n=0), moderate (n=40), or severe (n=12). The special type is associated with additional symptoms of pelvic tilt and leg length discrepancy (4 cm in 48 hips). 311 hips had pelvic tilt and 47 hips had lumbar compensatory scoliosis. Treatment outcome was assessed at 6 months. Hip functional score was assessed at the final follow-up. The mean hospitalisation period was 11 days. After a mean follow-up of 1.5 years, the mean hip functional score improved from 8.03 to 11.69; improvement was higher in children (age 5-13 years) than in adolescents (age 14-18 years) [3.7 vs. 2.9, p4 cm, and intra-operatively the contracture band severely affected the joint capsule. The third patient did not comply with postoperative exercises. Surgical treatment for severe gluteal muscle contracture achieved good outcome.

  17. Effects of electrical stimulation-induced gluteal versus gluteal and hamstring muscles activation on sitting pressure distribution in persons with a spinal cord injury.

    Science.gov (United States)

    Smit, C A J; Haverkamp, G L G; de Groot, S; Stolwijk-Swuste, J M; Janssen, T W J

    2012-08-01

    Ten participants underwent two electrical stimulation (ES) protocols applied using a custom-made electrode garment with built-in electrodes. Interface pressure was measured using a force-sensitive area. In one protocol, both the gluteal and hamstring (g+h) muscles were activated, in the other gluteal (g) muscles only. To study and compare the effects of electrically induced activation of g+h muscles versus g muscles only on sitting pressure distribution in individuals with a spinal cord injury (SCI). Ischial tuberosities interface pressure (ITs pressure) and pressure gradient. In all participants, both protocols of g and g+h ES-induced activation caused a significant decrease in IT pressure. IT pressure after g+h muscles activation was reduced significantly by 34.5% compared with rest pressure, whereas a significant reduction of 10.2% after activation of g muscles only was found. Pressure gradient reduced significantly only after stimulation of g+h muscles (49.3%). g+h muscles activation showed a decrease in pressure relief (Δ IT) over time compared with g muscles only. Both protocols of surface ES-induced of g and g+h activation gave pressure relief from the ITs. Activation of both g+h muscles in SCI resulted in better IT pressure reduction in sitting individuals with a SCI than activation of g muscles only. ES might be a promising method in preventing pressure ulcers (PUs) on the ITs in people with SCI. Further research needs to show which pressure reduction is sufficient in preventing PUs.

  18. MRI and US of gluteal tendinopathy in greater trochanteric pain syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Kong, Andrew; Van der Vliet, Andrew [Regional Imaging Border, Albury, NSW (Australia); Zadow, Steven [Dr Jones and Partners Medical Imaging, Adelaide, SA (Australia)

    2007-07-15

    Greater trochanteric pain syndrome is commonly due to gluteus minimus or medius injury rather than trochanteric bursitis. Gluteal tendinopathy most frequently occurs in late-middle aged females. In this pictorial review the pertinent MRI and US anatomy of the gluteal tendon insertions on the greater trochanter and the adjacent bursae are reviewed. The direct (peritendinitis, tendinosis, partial and complete tear) and indirect (bursal fluid, bony changes and fatty atrophy) MRI signs of gluteal tendon injury are illustrated. The key sonographic findings of gluteal tendinopathy are also discussed. (orig.)

  19. Percutaneous Fascia Release for Treating Chronic Recurrent Gluteal Myofascial Pain—A Pilot Study of a New Technique

    Directory of Open Access Journals (Sweden)

    Hsin-Shui Chen

    2015-01-01

    Full Text Available Objective To investigate the therapeutic effectiveness of percutaneous fascia release to treat chronic recurrent gluteal myofascial pain related to recurrent tendonitis or bursitis at the attachment sites. Methods Five patients (three males, two females; aged 48.6 ± 8.9 years with myofascial trigger points in the gluteus medius muscle were treated. Outcome measures, including pain intensity, pressure pain threshold, and the relative strength of hip abduction, were assessed before, immediately after, and six months after the treatment. The data measured before and after treatment (different times on visual analog scale, pressure pain threshold, and relative hip abduction strength were analyzed by Wilcoxon signed-rank test and paired t -test, respectively, for the comparisons between time points. Results Reduction in pain intensity and increase in the pressure pain threshold and the relative hip abduction strength were found in all five patients after treatment when compared with those of before treatment ( P 0.05. Conclusions Percutaneous fascia release of gluteal muscle insertion sites can be used to treat chronic gluteal pain related to subtrochanteric bursitis to avoid recurrence, if other treatment cannot control the recurrence, although this was demonstrated only on a small sample size without control and blind assessment in the pilot study.

  20. Effects of transcutaneous electrical nerve stimulation on pain intensity during application of carboxytherapy in patients with cellulite: A randomized placebo-controlled trial.

    Science.gov (United States)

    Sadala, Adria Y; Machado, Aline F P; Liebano, Richard E

    2018-01-16

    Carboxytherapy may generate local pain that is considered the main limiting factor in clinical practice. Transcutaneous electric nerve stimulation (TENS) is widely used in the control of acute pain; however, the effect of TENS on pain relief during carboxytherapy has not been studied to date. To assess the effect of TENS on pain intensity during carboxytherapy in patients with cellulite in the gluteal region. This randomized clinical trial was conducted with 84 patients, 18-44 years of age, who had moderate cellulite in the gluteal region, according to Cellulite Severity Scale, but never received carboxytherapy. Patients were randomized into 3 groups: active TENS, placebo TENS, and control group. For the intervention, skin depressions with cellulite were outlined, and the gluteal area to be treated was defined. The subcutaneous injection of CO 2 was performed using 0.30 × 13 mm-needles at a 45° angle, with a controlled flow rate of 100 mL/min maintained for 1 minute at each puncture site. The parameters for TENS were as follows: frequency of 100 Hz and pulse duration of 200 μs; TENS intensity was adjusted until the patient reported strong paresthesia. The visual numeric pain rating scale was used to assess pain intensity after each puncture. The active TENS group reported lower pain intensity compared to the placebo TENS (P TENS) was effective in reducing pain intensity during carboxytherapy in patients with cellulite in the gluteal region. © 2018 Wiley Periodicals, Inc.

  1. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  2. Congenital heart disease in adolescents with gluteal muscle contracture.

    Science.gov (United States)

    You, Tian; Zhang, Xin-tao; Zha, Zhen-gang; Zhang, Wen-tao

    2015-02-01

    Gluteal muscle contracture (GMC), presented with hip abduction and external rotation when crouching, is common in several ethnicities, particularly in Chinese. It remains unclear that the reasons why these children are weak and have no choice to accept repeated intramuscular injection. Here, we found some unique cases which may be useful to explain this question. We describe a series of special GMC patients, who are accompanied with congenital heart disease (CHD). These cases were first observed in preoperative examinations of a patient with atrial septal defect (ASD), which was proved by chest X-ray and cardiac ultrasound. From then on, we gradually identified additional 3 GMC patients with CHD. The original patient with ASD was sent to cardiosurgery department to repair atrial septal first and received arthroscopic surgery later. While the other 3 were cured postoperative of ventricular septal defect (VSD), tetralogy of fallot (TOF), patent ductus arteriosus (PDA), respectively, and had surgery directly. The study gives us 3 proposals: (1) as to CHD children, it is essential to decrease the use of intramuscular injection, (2) paying more attention to cardiac examination especially cardiac ultrasound in perioperative period, and (3) taking 3D-CT to reconstruct gluteal muscles for observing contracture bands clearly in preoperation. However, more larger series of patients are called for to confirm these findings.

  3. Multisite Infection with Mycobacterium abscessus after Replacement of Breast Implants and Gluteal Lipofilling.

    Science.gov (United States)

    Rüegg, Eva; Cheretakis, Alexandre; Modarressi, Ali; Harbarth, Stephan; Pittet-Cuénod, Brigitte

    2015-01-01

    Introduction. Medical tourism for aesthetic surgery is popular. Nontuberculous mycobacteria (NTM) occasionally cause surgical-site infections. As NTM grow in biofilms, implantations of foreign bodies are at risk. Due to late manifestation, infections occur when patients are back home, where they must be managed properly. Case Report. A 39-year-old healthy female was referred for acute infection of the right gluteal area. Five months before, she had breast implants replacement, abdominal liposuction, and gluteal lipofilling in Mexico. Three months postoperatively, implants were removed for NTM-infection in Switzerland. Adequate antibiotic treatment was stopped after seven days for drug-related hepatitis. At entrance, gluteal puncture for bacterial analysis was performed. MRI showed large subcutaneous collection. Debridement under general anaesthesia was followed by open wound management. Total antibiotic treatment was 20 weeks. Methods. Bacterial analysis of periprosthetic and gluteal liquids included Gram-stain plus acid-fast stain, and aerobic, anaerobic and mycobacterial cultures.  Results. In periprosthetic fluid, Mycobacterium abscessus, Propionibacterium, and Staphylococcus epidermidis were identified. The same M. abscessus strain was found gluteally. The gluteal wound healed within six weeks. At ten months' follow-up, gluteal asymmetry persists for deep scarring. Conclusion. This case presents major complications of multisite aesthetic surgery. Surgical-site infections in context of medical tourism need appropriate bacteriological investigations, considering potential NTM-infections.

  4. Gluteal Hydatid Cyst: Report of a Case from Iran

    Directory of Open Access Journals (Sweden)

    Behzad NEMATI HONA

    2017-06-01

    Full Text Available Hydatid cyst involves both hard and soft tissues even without the evidence of the disease in liver or lungs; however, this manifestation is very rare, particularly in musculoskeletal regions. The current report describes a case with primary diagnose of cystic gluteal swelling leading to diagnose of hydatid cyst after surgical exploration in an 80-yr-old woman the Surgical Outpatient Department, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. During surgery, the cavity was washed by silver nitrate and the cyst content was appropriately evacuated. The patient had completed a   short course of albendazole postoperatively. Early postoperative complications were not appeared. The patient was followed for 6 months with no evidence of recurrence or complications. 

  5. Prolonged electrical stimulation-induced gluteal and hamstring muscle activation and sitting pressure in spinal cord injury: Effect of duty cycle

    OpenAIRE

    Christof A. J. Smit, MD; Karin J. A. Legemate, MSc; Anja de Koning, MSc; Sonja de Groot, PhD; Janneke M. Stolwijk-Swuste, MD, PhD; Thomas W. J. Janssen, PhD

    2013-01-01

    Pressure ulcers (PUs) are highly prevalent in people with spinal cord injury (SCI). Electrical stimulation (ES) activates muscles and might reduce risk factors. Our objectives were to study and compare the effects of two duty cycles during 3 h of ES-induced gluteal and hamstring activation on interface pressure distribution in sitting individuals with SCI and study the usability of a newly developed electrode garment (ES shorts). Ten individuals with SCI participated in this study, in which t...

  6. [Characteristics and role of the gluteal herpes in a female population].

    Science.gov (United States)

    Suárez, M; Saavedra, T; Briones, H

    1989-01-01

    Based on the fact that the gluteal herpes may constitute the clinical expression of the reactivation of a Herpes simplex virus latent at the sacral lymph node, we investigated a group of women who were carriers of gluteal herpetic infection, the characteristics of the infection, the virus type principally associated to it, and its possible relation with the genital herpes. Forty one women with gluteal herpes verified by virologic laboratory were studied. 75.7% of these women had had in addition to this herpetic infection in other places, mainly genital, with an average of 7.2 of recurrent episodes per year, (range: 1 to 18 episodes yearly). 78% of the isolated virus was typified as HSV-2 by the use of monoclonal antibodies. It is stand out the importance of considering the background of gluteal herpes as causative of classification of herpetic high risk.

  7. Which level is responsible for gluteal pain in lumbar disc hernia?

    Science.gov (United States)

    Fang, Guofang; Zhou, Jianhe; Liu, Yutan; Sang, Hongxun; Xu, Xiangyang; Ding, Zihai

    2016-08-22

    There are many different reasons why patients could be experiencing pain in the gluteal area. Previous studies have shown an association between radicular low back pain (LBP) and gluteal pain (GP). Studies locating the specific level responsible for gluteal pain in lumbar disc hernias have rarely been reported. All patients with lumbar disc herniation (LDH) in the Kanghua hospital from 2010 to 2014 were recruited. All patients underwent a lumbar spine MRI to clarify their LDH diagnosis, and patients were allocated to a GP group and a non-GP group. To determine the cause and effect relationship between LDH and GP, all of the patients were subjected to percutaneous endoscopic lumbar discectomy (PELD). A total of 286 cases were included according to the inclusive criteria, with 168 cases in the GP group and 118 cases in the non-GP group. Of these, in the GP group, 159 cases involved the L4/5 level and 9 cases involved the L5/S1 level, while in the non-GP group, 43 cases involved the L4/5 level and 48 cases involved the L5/S1 level. PELD was performed in both groups. Gluteal pain gradually disappeared after surgery in all of the patients. Gluteal pain recrudesced in a patient with recurrent disc herniation (L4/5). As a clinical finding, gluteal pain is related to low lumbar disc hernia. The L4/5 level is the main level responsible for gluteal pain in lumbar disc hernia. No patients with gluteal pain exhibited involvement at the L3/4 level.

  8. The relationship between hamstring length and gluteal muscle strength in individuals with sacroiliac joint dysfunction

    OpenAIRE

    Massoud Arab, Amir; Reza Nourbakhsh, Mohammad; Mohammadifar, Ali

    2011-01-01

    It has been suggested that tight hamstring muscle, due to its anatomical connections, could be a compensatory mechanism for providing sacroiliac (SI) joint stability in patients with gluteal muscle weakness and SIJ dysfunction. The purpose of this study was to determine the relationship between hamstring muscle length and gluteal muscle strength in subjects with sacroiliac joint dysfunction. A total of 159 subjects with and without low back pain (LBP) between the ages of 20 and 65 years parti...

  9. An Interesting Fistula Tract Presenting with Recurrent Gluteal Abscess: Instructive Case

    Directory of Open Access Journals (Sweden)

    Gulsum Iclal Bayhan

    2015-01-01

    Full Text Available A fistula extending from the gluteus to penis is an extremely rare entity. In this paper, we have highlighted novel variant of congenital penile to gluteal fistula complicated with gluteal and penoscrotal abscess in a previously healthy boy. A fistulous tract extending from the gluteus to penis has been shown by fistulogram. Bleomycin has been used in fistula tract with successful results in our patient.

  10. Bilateral post-traumatic gluteal compartment syndrome: A case report and review of literature

    Directory of Open Access Journals (Sweden)

    Devashis Barick

    2015-01-01

    Full Text Available Gluteal compartment is a rare site for compartment syndrome. Gluteal compartment syndrome has most commonly been described in the literature as occurring after prolonged immobility associated with substance abuse, improper operative positioning, sickle cell-induced infarct, post-traumatic and spontaneous superior gluteal artery rupture, exercise, and post-arterial embolization of the internal iliac artery prior to abdominal aortic aneurysm repair. Trauma is rarely associated with this syndrome. Gluteal compartment syndrome occurs in approximately 0.9% of trauma patients. Posttraumatic gluteal compartment syndrome develops because of edema with traumatic contusions, crush injuries and hematoma formation due to blunt superior or inferior gluteal artery injuries in all compartments of the gluteal region Only 6 previous cases have been reported in the literature. Two previous cases involved positioning for urological procedures, while the other cited causes of bilateral gluteal compartment syndrome include exercise-induced, trauma, and prolonged immobilization from substance abuse. One of the most immediately devastating results of a missed compartment syndrome is the risk of the development of rhabdomyolysis with the resulting squeal of myoglobinuria, hyperkalemia, and acidosis resulting in renal failure, shock, multiple organ failure, disseminated intravascular coagulation, and possibly death. Here we report a case of posttraumatic bilateral compartment syndrome which developed secondary to pressure due to patient being trapped under a vehicle following a vehicular accident. He was operated upon and a bilateral fasciotomy was done. Although he did not develop any renal complications, the sciatic nerve palsy on the left side did not recover. The patient is still under follow up.

  11. Clinical Trial Of Glimepiride Compared With Glibenclamide For ...

    African Journals Online (AJOL)

    Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria. Study design: An open, randomised controlled trial. Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria. Subjects: Seventy four ...

  12. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  13. [The first exploration of a minimally invasive lysis subcutaneouly for the treatment of gluteal muscle contracture based on relatively safe region around standard injection point of gluteal muscle].

    Science.gov (United States)

    Xiao, Ying; Tang, Zhi-hong; Zhang, Si-rong; Zou, Guo-yao; Xiao, Rong-chi; Liu, Rui-duan; Hu, Jun-zu

    2011-06-01

    To explore the solution of choosing the minimally invasive incision site for gluteal muscle contracture patient based on standard injection point of gluteal muscle. from September 2008 to August 2010, 25 patients (14 males and 11 females with an average of 16.5 years, ranging from 12 to 26 years) with injected gluteal muscle contracture were prospectively studied. The course of disease was from 6 to 12 years. Firstly, the connective skin Surface line from anterior superior iliac spine to coccyx (line AD) was delineated and the point (point O) was marked out as the standard gluteal muscle injection site which was on the one-third of the distance from the anterior superior iliac spine(point A) to the coccyx (point D). Secondly, the anterior and posterior edge lines of surface projection of the gluteal muscle contracture banding (line a, line p) were delineated. Thirdly, the distance from B to O and C to O (B is the point of intersection of line a and line AD,C is the point of intersection of line P and line AD)were measured which was the intersection of line a,p and line AD to point O. Lastly, the minimally invasive surgery was operformed via the skin entry of point C. OB = (0 +/- 0.76) cm, OC = (2.86 +/- 0.78) cm, BC = (2.86 +/- 1.01) cm,the mean postoperative drainage was less than 10 ml,there was no nerve damage,hematoma and other complications. All patients achieved the function of squatting in 4 to 6 days. The solution of choosing the minimally invasive incision site based on standard injection point of gluteal muscle has advantages of positioning precisely,handling easily, recoverying quickly, less trauma and safety, etc.

  14. Changes in gluteal muscle forces with alteration of footstrike pattern during running.

    Science.gov (United States)

    Vannatta, Charles Nathan; Kernozek, Thomas W; Gheidi, Naghmeh

    2017-10-01

    Gait retraining is a common form of treatment for running related injuries. Proximal factors at the hip have been postulated as having a role in the development of running related injuries. How altering footstrike affects hip muscles forces and kinematics has not been described. Thus, we aimed to quantify differences in hip muscle forces and hip kinematics that may occur when healthy runners are instructed to alter their foot strike pattern from their habitual rear-foot strike to a forefoot strike. This may gain insight on the potential etiology and treatment methods of running related lower extremity injury. Twenty-five healthy female runners completed a minimum of 10 running trials in a controlled laboratory setting under rear-foot strike and instructed forefoot strike conditions. Kinetic and kinematic data were used in an inverse dynamic based static optimization to estimate individual muscle forces during running. Within subject differences were investigated using a repeated measures multi-variate analysis of variance. Peak gluteus medius and minimus and hamstring forces were reduced while peak gluteus maximus force was increased when running with an instructed forefoot strike pattern. Peak hip adduction, hip internal rotation, and heel-COM distance were also reduced. Therefore, instructing habitual rearfoot strike runners to run with a forefoot strike pattern resulted in changes in peak gluteal and hamstring muscle forces and hip kinematics. These changes may be beneficial to the development and treatment of running related lower extremity injury. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Anatomical relation between S1 sacroiliac screws' entrance points and superior gluteal artery.

    Science.gov (United States)

    Zhao, Yong; You, Libo; Lian, Wei; Zou, Dexin; Dong, Shengjie; Sun, Tao; Zhang, Shudong; Wang, Dan; Li, Jingning; Li, Wenliang; Zhao, Yuchi

    2018-01-18

    To conduct radiologic anatomical study on the relation between S1 sacroiliac screws' entry points and the route of the pelvic outer superior gluteal artery branches with the aim to provide the anatomical basis and technical reference for the avoidance of damage to the superior gluteal artery during the horizontal sacroiliac screw placement. Superior gluteal artery CTA (CT angiography) vascular imaging of 74 healthy adults (37 women and 37 men) was done with 128-slice spiral CT (computed tomography). The CT attendant-measuring software was used to portray the "safe bony entrance area" (hereinafter referred to as "Safe Area") of the S1 segment in the standard lateral pelvic view of three-dimensional reconstruction. The anatomical relation between S1 sacroiliac screws' Safe Area and the pelvic outer superior gluteal artery branches was observed and recorded. The number of cases in which artery branches intersected the Safe Area was counted. The cases in which superior gluteal artery branches disjointed from the Safe Area were identified, and the shortest distance between the Safe Area and the superior gluteal artery branch closest to the Safe Area was measured. Three cases out of the 74 sample cases were excluded from this study as they were found to have no bony space for horizontal screw placement in S1 segment. Among the remaining 71 sample cases, there are 32 cases (45.1%) where the deep superior branch of superior gluteal artery passes through the Safe Area of S1 entrance point. There was no distinguishing feature and rule on how the deep superior branches and the Safe Area overlapped. In the 39 cases in which superior gluteal artery branches disjointed from the Safe Area, the deep superior branches of superior gluteal artery were the branches closest to the Safe Area and the part of the branch closest to the Safe Area was located in front of the widest part of the Safe Area. The shortest distance between the deep superior branch and the Safe Area is 0.86

  16. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis.

    Science.gov (United States)

    Jacobson, Jon A; Yablon, Corrie M; Henning, P Troy; Kazmers, Irene S; Urquhart, Andrew; Hallstrom, Brian; Bedi, Asheesh; Parameswaran, Aishwarya

    2016-11-01

    The purpose of this study was to compare ultrasound-guided percutaneous tendon fenestration to platelet-rich plasma (PRP) injection for treatment of greater trochanteric pain syndrome. After Institutional Review Board approval was obtained, patients with symptoms of greater trochanteric pain syndrome and ultrasound findings of gluteal tendinosis or a partial tear (Pain scores were recorded at baseline, week 1, and week 2 after treatment. Retrospective clinic record review assessed patient symptoms. The study group consisted of 30 patients (24 female), of whom 50% were treated with fenestration and 50% were treated with PRP. The gluteus medius was treated in 73% and 67% in the fenestration and PRP groups, respectively. Tendinosis was present in all patients. In the fenestration group, mean pain scores were 32.4 at baseline, 16.8 at time point 1, and 15.2 at time point 2. In the PRP group, mean pain scores were 31.4 at baseline, 25.5 at time point 1, and 19.4 at time point 2. Retrospective follow-up showed significant pain score improvement from baseline to time points 1 and 2 (P.99). Our study shows that both ultrasound-guided tendon fenestration and PRP injection are effective for treatment of gluteal tendinosis, showing symptom improvement in both treatment groups. © 2016 by the American Institute of Ultrasound in Medicine.

  17. Effects of electrical stimulation-induced gluteal versus gluteal and hamstring muscles activation on sitting pressure distribution in persons with a spinal cord injury

    NARCIS (Netherlands)

    Smit, C. A. J.; Haverkamp, G. L. G.; de Groot, S.; Stolwijk-Swuste, J. M.; Janssen, T. W. J.

    Study design: Ten participants underwent two electrical stimulation (ES) protocols applied using a custom-made electrode garment with built-in electrodes. Interface pressure was measured using a force-sensitive area. In one protocol, both the gluteal and hamstring (g+h) muscles were activated, in

  18. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  19. Delayed Presentation of Gluteal Compartment Syndrome: The Argument for Fasciotomy

    Directory of Open Access Journals (Sweden)

    John E. Lawrence

    2016-01-01

    Full Text Available A male patient in his fifties presented to his local hospital with numbness and weakness of the right leg which left him unable to mobilise. He reported injecting heroin the previous morning. Following an initial diagnosis of acute limb ischaemia the patient was transferred to a tertiary centre where Computed Tomography Angiography was reported as normal. Detailed neurological examination revealed weakness in hip flexion and extension (1/5 on the Medical Research Council scale with complete paralysis of muscle groups distal to this. Sensation to pinprick and light touch was globally reduced. Blood tests revealed acute kidney injury with raised creatinine kinase and the patient was treated for rhabdomyolysis. Orthopaedic referral was made the following day and a diagnosis of gluteal compartment syndrome (GCS was made. Emergency fasciotomy was performed 56 hours after the onset of symptoms. There was immediate neurological improvement following decompression and the patient was rehabilitated with complete nerve recovery and function at eight-week follow-up. This is the first documented case of full functional recovery following a delayed presentation of GCS with sciatic nerve palsy. We discuss the arguments for and against fasciotomy in cases of compartment syndrome with significant delay in presentation or diagnosis.

  20. GIANT GLUTEAL LIPOMA: A CASE REPORT AND REVIEW OF LITERATURE

    Directory of Open Access Journals (Sweden)

    PRASHANT HOMBAL

    2015-05-01

    Full Text Available Introduction : Lipoma is one of the most common benign mesenchymal tumor which can occur in almost in all organs of the body where fat normally exists, so called as universal tumor or ubiquitous tumor. Lipomas are slow growing that rarely reach a size more than 2-3cms. Lesions larger than 5cms, so called giant lipomas are seldom found inside the muscle compressing nervous-vascular structures. The large and deep seated lipomas represent a real diagnostic and therapeutic challenge. Case report: We report a case of 48 year old man with a giant lipoma involving his left gluteal and thigh region. The patient was managed by wide local excision of the lesion. The key issues surrounding the intramuscular lipoma with literature review is discussed. Conclusion: Intramuscular Giant lipomas are rare and even though they are typical in their presentation, especially when they are large and show findings that can be confused with a well-differentiated low grade liposarcoma, but when they occur an appropriate workup must be done. This should be followed by adequate open surgical excision and repeat examination over time to monitor for recurrence.

  1. Aberrant femoral torsion presenting with frog-leg squatting mimicking gluteal muscle contracture.

    Science.gov (United States)

    Chiang, Chia-Ling; Tsai, Meng-Yuan; Chang, Wei-Ning; Chen, Clement Kuen-Huang

    2012-04-01

    Patients with frog-leg squatting have restricted internal rotation and adduction of the affected hips during sitting or squatting. In the surgical literature, the cause generally has been presumed to arise from and be pathognomonic for gluteal muscle contracture. However, we have encountered patients with frog-leg squatting but without gluteal muscle contracture. We therefore raised the following questions: What are the imaging features of patients with frog-leg squatting? Do conditions other than gluteal muscle contracture manifest frog-leg squatting? We retrospectively reviewed the MR images of 67 patients presenting with frog-leg squatting from April 1998 to July 2010. There were four females and 63 males; their mean age was 22.2 years (range, 4-50 years). During MRI readout, we observed aberrant axes of some femoral necks and obtained additional CT to measure femoral torsion angles in 59 of the 67 patients. MR images of 27 (40%) patients had signs of gluteal muscle contracture. Twenty-two (33%) patients (40 femora) had aberrant femoral torsion, including diminished anteversion (range, 6°-0°; average, 3.9°) in 11 femora of eight patients and femoral retroversion (range, muscle contracture or aberrant femoral torsion. The observation of aberrant femoral torsion was not anticipated before imaging studies. In addition to gluteal muscle contracture, aberrant femoral torsion can be a cause of frog-leg squatting. Level II, diagnostic study. See the guidelines for Authors for a complete description of levels of evidence.

  2. Sedentary lifestyle related exosomal release of Hotair from gluteal-femoral fat promotes intestinal cell proliferation.

    Science.gov (United States)

    Lu, Xiaozhao; Bai, Danna; Liu, Xiangwei; Zhou, Chen; Yang, Guodong

    2017-03-31

    Pioneering epidemiological work has established strong association of sedentary lifestyle and obesity with the risk of colorectal cancer, while the detailed underlying mechanism remains unknown. Here we show that Hotair (HOX transcript antisense RNA) is a pro-adipogenic long non-coding RNA highly expressed in gluteal-femoral fat over other fat depots. Hotair knockout in adipose tissue results in gluteal-femoral fat defect. Squeeze of the gluteal-femoral fat induces intestinal proliferation in wildtype mice, while not in Hotair knockout mice. Mechanistically, squeeze of the gluteal-femoral fat induces exosomal Hotair secretion mainly by transcriptional upregulation of Hotair via NFκB. And increased exosomal Hotair in turn circulates in the blood and is partially endocytosed by the intestine, finally promoting the stemness and proliferation of intestinal stem/progenitor cells via Wnt activation. Clinically, obese subjects with sedentary lifestyle have much higher exosomal HOTAIR expression in the serum. These findings establish that sedentary lifestyle promotes exosomal Hotair release from the gluteal-femoral fat, which in turn facilitates intestinal stem and/or progenitor proliferation, raising a possible link between sedentary lifestyle with colorectal tumorigenesis.

  3. Comparison of gluteal and hamstring activation during five commonly used plyometric exercises.

    Science.gov (United States)

    Struminger, Aaron H; Lewek, Michael D; Goto, Shiho; Hibberd, Elizabeth; Blackburn, J Troy

    2013-08-01

    Anterior cruciate ligament injuries occur frequently in athletics, and anterior cruciate ligament injury prevention programs may decrease injury risk. However, previous prevention programs that include plyometrics use a variety of exercises with little justification of exercise inclusion. Because gluteal and hamstring activation is thought to be important for preventing knee injuries, the purpose of this study was to determine which commonly used plyometric exercises produce the greatest activation of the gluteals and hamstrings. EMG (Electromyography) amplitudes of the hamstring and gluteal muscles during preparatory and loading phases of landing were recorded in 41 subjects during 5 commonly used plyometric exercises. Repeated measures ANOVAs (Analysis of Variance) were used on 36 subjects to examine differences in muscle activation. Differences in hamstring (Pplyometric exercises, their removal from injury prevention programs may be warranted without affecting program efficacy. © 2013.

  4. Gluteal Compartment Syndrome following bariatric surgery: A rare but important complication

    Directory of Open Access Journals (Sweden)

    Bernadette Pereira

    2015-03-01

    Full Text Available Gluteal Compartment Syndrome is a rare condition caused by excessive pressure within the gluteal compartments which leads to a number of potentially serious sequelae including rhabdomyolysis, nerve damage, renal failure and death. As bariatric patients are heavy and during prolonged bariatric procedures lie in one position for extended periods of time, they are especially susceptible to developing this complication. It is therefore essential that bariatric surgeons are aware of this complication and how to minimise the chances of it occurring and how to diagnose it. We describe a case of Gluteal Compartment Syndrome in a patient following a gastric bypass and review the aetiology, pathophysiology, treatment and prevention of this complication.

  5. A randomized trial comparing treatments for varicose veins.

    Science.gov (United States)

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

    2014-09-25

    Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (Pdisease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

  6. The relationship between gluteal muscle activation and throwing kinematics in baseball and softball catchers.

    Science.gov (United States)

    Plummer, Hillary A; Oliver, Gretchen D

    2014-01-01

    The purpose of this study was to determine the relationship between gluteal muscle activation and pelvis and trunk kinematics when catchers throw to second base. Forty-two baseball and softball catchers (14.74 ± 4.07 years; 161.85 ± 15.24 cm; 63.38 ± 19.98 kg) participated in this study. Muscle activity of the bilateral gluteus maximus and medius as well as pelvis and trunk kinematics throughout the throwing motion were analyzed. It was discovered that at foot contact, there were 2 significant inverse relationships between stride leg gluteus maximus activity and pelvis axial rotation (r = -0.31, r2 = 0.10, p = 0.05), and between trunk axial rotation and pelvis lateral flexion (r = -0.34, r2= 0.12, p = 0.03). In addition, at foot contact, a significant positive relationship between the drive leg (throwing arm side) and trunk flexion (r = 0.33, r2 = 0.11, p = 0.04) was present. The results of this study provide evidence of gluteal activation both concentrically and eccentrically, in attempt to control the pelvis and trunk during the throwing motion of catchers. The gluteal muscles play a direct role in maintaining the stability of the pelvis, and catchers should incorporate strengthening of the entire lumbopelvic-hip complex into their training regimen. Incorporating concentric and eccentric gluteal exercises will help to improve musculoskeletal core stability, thereby assisting in upper extremity injury prevention.

  7. New minimally invasive option for the treatment of gluteal muscle contracture.

    Science.gov (United States)

    Ye, Bin; Zhou, Panyu; Xia, Yan; Chen, Youyan; Yu, Jun; Xu, Shuogui

    2012-12-01

    Gluteal muscle contracture is a clinical syndrome that involves contracture and distortion of the gluteal muscles and fascia fibers due to multiple causes. Physical examination demonstrates a characteristic gait due to hip adduction and internal thigh rotation. This study introduces a new minimally invasive method for surgical release of gluteal muscle contracture. Patients with gluteal muscle contracture were assigned to 4 categories: type A, contracture occurred mainly in the iliotibial tract; type B, contracture occurred in the Iliotibial tract and gluteus maximus; type C1, movement of the contraction band was palpable and a snapping sound was audible during squatting; and type C2, movement of the contraction band was not palpable or almost absent and a snapping sound was audible during squatting. This classification method allowed prediction of the anatomic location of these pathological contractures and determination of the type of surgery required. Four critical points were used to define the operative field and served as points to mark a surgical incision smaller than 4 mm. The contracture was easily released in this carefully marked operative field without causing significant neurovascular damage. Over a period of 5 years, between March 2003 and June 2008, the authors treated 1059 patients with this method and achieved excellent outcomes. Most patients were fully active within 12 weeks, with the assistance of an early postoperative rehabilitation program. The most significant complication was a postoperative periarticular hematoma, which occurred in 3 patients within 10 days postoperatively and required surgical ligation of the bleeding vessel. Copyright 2012, SLACK Incorporated.

  8. Performance Effects of Repetition Specific Gluteal Activation Protocols on Acceleration in Male Rugby Union Players

    Directory of Open Access Journals (Sweden)

    Barry Lorna

    2016-12-01

    Full Text Available Warm-up protocols have the potential to cause an acute enhancement of dynamic sprinting performance. The purpose of this study was to evaluate the effects of three repetition specific gluteal activation warm-up protocols on acceleration performance in male rugby union players. Forty male academy rugby union players were randomly assigned to one of 4 groups (control, 5, 10 or 15 repetition gluteal activation group and performed 10 m sprints at baseline and 30 s, 2, 4, 6 and 8 min after their specific intervention protocol. Five and ten meter sprint times were the dependent variable and dual-beam timing gates were used to record all sprint times. Repeated measures analysis of variance found no significant improvement in 5 and 10 m sprint times between baseline and post warm-up scores (p ≥ 0.05 for all groups. There were no reported significant differences between groups at any of the rest interval time points (p ≥ 0.05. However, when individual responses to the warm-up protocols were analyzed, the 15 repetition gluteal activation group had faster 10 m times post-intervention and this improvement was significant (p = 0.021. These results would indicate that there is no specific rest interval for any of the gluteal interventions that results in a potentiation effect on acceleration performance. However, the individual response analysis would seem to indicate that a 15 repetition gluteal activation warm-up protocol has a potentiating effect on acceleration performance provided that the rest interval is adequately and individually determined.

  9. Comparing abrupt and gradual smoking cessation: a randomized trial.

    Science.gov (United States)

    Etter, Jean-François

    2011-11-01

    To compare abrupt and gradual smoking cessation. Randomized trial and observational study, Internet, 2007-2010. Smokers with no strong preference for abrupt or gradual quitting were randomly assigned to quitting immediately (n=472), or to gradually reducing their cigarette consumption over 2 weeks and then quit (n=502). Smokers who strongly preferred to quit abruptly were instructed to do so immediately (n=2456), those who strongly preferred gradual were instructed to reduce their cigarette consumption over 2 weeks, then quit (n=1801). Follow-up was conducted 4 weeks after target quit dates. Those who preferred abrupt quitting were the most motivated to quit and the most confident in their ability to quit. At follow-up, quit rates were 16% in those who preferred abrupt cessation, 7% in those who preferred gradual cessation and 9% in those who had no preference (pmotivation to quit and confidence in ability to quit: those who had low levels of motivation or low levels of confidence were more likely to quit at follow-up if they preferred and used abrupt rather than gradual. In those who had no strong preference for either method, abrupt and gradual produced similar results. Those who preferred and used the abrupt method were more likely to quit than those who preferred and used the gradual method, in particular when they had low motivation and confidence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  10. Clinical trial of osteoarthritis jamu formula compare to piroxicam

    Directory of Open Access Journals (Sweden)

    Danang Ardiyanto

    2016-12-01

    is a lack of evidence of its efficacy and safety. The objectives of study were to investigate the efficacy and safety of  a traditional formula for OA. Methods: Design of the study was a randomized clinical trial (RCT involved 123 patients (subjects for 28 days intervention. This study was conducted between March - December 2014 with 30 physicians were participated at 20 regencies in Indonesia. The variables measured were VAS score, PGAP functional status assessment (FSA, and Short Form (SF-36 to assess jamu efficacy in comparison to piroxicam. To evaluate the safety of jamu formula using values of SGOT, SGPT, BUN, and creatinine. Result: The jamu formula administration effects can reduce VAS significantly  (p<0.05  if it was compared to baseline. FSA score of jamu formula group was decreased significantly (p=0.000 when compared to the start of intervention. Short Form (SF-36 of jamu formula group were significantly improved when compared with baseline value. The result of the three parameters between jamu group and piroxicam group should not significantly different. There was no difference in those parameters between both groups (p>0.05. In biological parameters, SGPT, SGOT, BUN, and creatinine level, showed normal range in both groups. Conclusion: This study showed that the efficacy and safety of jamu formula was clinically comparable to piroxicam after 28 days of treatment. Keywords: efficacy, safety, RCT, jamu formula  

  11. Gluteal Augmentation With Intramuscular Implants in Patients With Human Immunodeficiency Virus With Lipoatrophy Related to the Use of Antiretroviral Therapy.

    Science.gov (United States)

    Andrade, Guilherme Augusto; Coltro, Pedro Soler; Barros, Mário Eduardo; Müller Neto, Bruno Francisco; Lima, Renan Victor; Farina, Jayme Adriano

    2017-11-01

    Lipodystrophy syndrome associated with highly active antiretroviral therapy (HAART) may lead to low self-esteem and poor compliance with the drug treatment on patients infected with human immunodeficiency virus (HIV), which is a matter of concern for the health system. The aim of this study was to evaluate patients with HIV submitted to gluteal augmentation with intramuscular silicone implants to correct gluteal lipoatrophy related to the use of HAART. This is a retrospective evaluation of 10 patients submitted to gluteal augmentation with intramuscular silicone implant for correction of gluteal lipoatrophy related to the use of HAART, operated between 2012 and 2015. Postoperative complications and the degree of patient's satisfaction were analyzed. There were 3 postoperative complications including 1 case of surgical wound dehiscence and 2 cases of seroma. Six months after surgery, 8 patients had an excellent degree of satisfaction, and 2 patients had a good degree of satisfaction related to the procedure. Although this intervention does not offer functional advantages, it improves the body contour, increases patients' self-esteem, and helps them to accept their body image. These advantages can lead to higher compliance with prolonged HAART. Gluteal augmentation with intramuscular silicone implant can be a viable option to treat patients with HIV with gluteal lipoatrophy related to the use of HAART. The patients were satisfied with the outcomes of the procedure, and there were only minor self-limited postoperative complications.

  12. Acquired myospherulosis secondary to gluteal augmentation on fine needle aspiration cytology: A diagnostic challenge.

    Science.gov (United States)

    Alperstein, Susan; Dilcher, Thomas; Viswanathan, Kartik; Rao, Rema A; Siddiqui, Momin T; Giorgadze, Tamara

    2018-05-01

    A 30-year-old female presented with a three-month history of a multilocular cystic lesion over the lumbosacral spine. Fine-needle aspiration biopsy (FNA) of the lesion was performed at an outside institution, and a cytologic diagnosis, suspicious for chordoma, was rendered. The patient presented for surgical consultation at our institution. Repeat FNA demonstrated an unusual fat-like material. Upon further inquiry, the patient provided a recent history of gluteal contour improvement with fibroadipose tissue implants. A diagnosis of myospherulosis was made with a concurrent surgical pathology correlation. No evidence of chordoma was identified. To date, this is the first reported case of acquired myospherulosis in the context of gluteal contour enhancement and represents an important diagnostic pitfall to consider on cytology preparations. © 2017 Wiley Periodicals, Inc.

  13. [Clinical application of modified upper gluteal rhomboid fasciocutaneous flap in repairing sacrococcygeal pressure sores].

    Science.gov (United States)

    Jiang, Maohua; Yang, Xiaoliang; Wei, Bangmin; Li, Yinghao

    2012-03-01

    To investigate the method and effectiveness of repairing sacrococcygeal pressure sores with modified upper gluteal rhomboid fasciocutaneous flap. Between January 2004 and March 2011, 43 patients with sacrococcygeal pressure sores were treated. There were 25 males and 18 females with an average age of 63 years (range, 38-95 years). The disease duration was 3 months to 2 years and 6 months (mean, 8.5 months). The size of pressure sores ranged from 6 cm x 5 cm to 18 cm x 13 cm. According to the extent and lesion degree of pressure scores, 23 pressure sores were rated as degree III and 20 pressure sores as degree IV. The modified upper gluteal rhomboid flap was designed, one-side upper gluteal fasciocutaneous flaps were transplanted to repair sacrococcygeal pressure sores in 19 cases and two-side flaps in 24 cases. The size of one side flap ranged from 6.5 cm x 4.5 cm to 18.0 cm x 11.5 cm. Fluid under flap occurred in 1 case and edge necrosis of the flaps in 3 cases at 7 days after operation, which were cured after drainage and dressing change; the other flaps survived, and incisions healed by first intention. All patients were followed up 6 months to 3 years with an average of 11 months. Two patients relapsed at 5 months and 8 months, respectively; the other patients had no recurrence. The color of the flaps was normal, and the appearance and elasticity of the flaps were good. The modified upper gluteal rhomboid fasciocutaneous flap has the advantages of simple design and operation, less injury, and reliable effect in repairing sacrococcygeal pressure sores.

  14. Movement anatomy of the gluteal region and thigh of the giant anteater Myrmecophaga tridactyla (Myrmecophagidae: Pilosa)

    OpenAIRE

    Priscilla Rosa Queiroz Ribeiro; André Luiz Quagliatto Santos; Lucas de Assis Ribeiro; Tharlianne Alici Martins de Souza; Daniela Cristina Silva Borges; Rogério Rodrigues de Souza; Saulo Gonçalves Pereira

    2016-01-01

    Abstract: Locomotion reveals the displacement and behavior manner of the species in their daily needs. According to different needs of the several species, different locomotor patterns are adopted. The shapes and attachment points of muscles are important determinants of the movements performed and consequently, the locomotion and motion patterns of living beings. It was aimed to associate anatomical, kinesiology and biomechanics aspects of the gluteal region and thigh of the giant anteater t...

  15. Acute migraine therapy: recent evidence from randomized comparative trials

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...

  16. Movement anatomy of the gluteal region and thigh of the giant anteater Myrmecophaga tridactyla (Myrmecophagidae: Pilosa

    Directory of Open Access Journals (Sweden)

    Priscilla Rosa Queiroz Ribeiro

    2016-06-01

    Full Text Available Abstract: Locomotion reveals the displacement and behavior manner of the species in their daily needs. According to different needs of the several species, different locomotor patterns are adopted. The shapes and attachment points of muscles are important determinants of the movements performed and consequently, the locomotion and motion patterns of living beings. It was aimed to associate anatomical, kinesiology and biomechanics aspects of the gluteal region and thigh of the giant anteater to its moving characteristics and locomotor habits. It was used three specimens of Myrmecophaga tridactyla, settled in formaldehyde aqueous solution at 10% and subsequently, dissected using usual techniques in gross anatomy. The morphological characteristics of the gluteal region and thigh that influence the patterns of movement and locomotion of animals, were analyzed and discussed in light of literature. All muscles of the gluteal region and thigh of giant anteater show parallel arrangement of the muscular fibers, being flat or fusiform. These muscles are formed in the joint which the interpotent type biolever act. These morphological characteristics indicate a greater predominance of amplitude and movement speed at the expense of strength. On the other hand, features such as osteometric index and the observation of giant anteater motion indicate the opposite, what reflects this animal lack of expertise in locomotor habits and shows the need of future realization of more detailed studies in this subject.

  17. Endoscopic treatment of sciatic nerve entrapment in deep gluteal syndrome: Clinical results.

    Science.gov (United States)

    Aguilera-Bohorquez, B; Cardozo, O; Brugiatti, M; Cantor, E; Valdivia, N

    2018-05-25

    Deep gluteal syndrome (DGS) is characterized by compression, at extra-pelvic level, of the sciatic nerve within any structure of the deep gluteal space. The objective was to evaluate the clinical results in patients with DGS treated with endoscopic technique. Retrospective study of patients with DGS treated with an endoscopic technique between 2012 and 2016 with a minimum follow-up of 12 months. The patients were evaluated before the procedure and during the first year of follow-up with the WOMAC and VAIL scale. Forty-four operations on 41 patients (36 women and 5 men) were included with an average age of 48.4±14.5. The most common cause of nerve compression was fibrovascular bands. There were two cases of anatomic variant at the exit of the nerve; compression of the sciatic nerve was associated with the use of biopolymers in the gluteal region in an isolated case. The results showed an improvement of functionality and pain measured with the WOMAC scale with a mean of 63 to 26 points after the procedure (Pnerve. Four cases required revision at 6 months following the procedure due to compression of the scarred tissue surrounding the sciatic nerve. Endoscopic release of the sciatic nerve offers an alternative in the management of DGS by improving functionality and reducing pain levels in appropriately selected patients. Copyright © 2018 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Gluteal Black Market Silicone-induced Renal Failure: A Case Report and Literature Review.

    Science.gov (United States)

    Matson, Andrea; Faibisoff, Burt

    2017-11-01

    Very few cases of successful surgical treatment for renal failure due to gluteal silicone injections have been reported in the literature. The silicone toxicity and subsequent renal failure seem to follow repetitive silicone injections and silicone injections in large quantities. This is a case of a 31-year-old woman who developed renal failure after 6 years of gluteal silicone injections who underwent radical resection of bilateral gluteal regions in an attempt to mitigate her impending complete renal failure. A systematic review of the literature was conducted using PubMed database and with assistance from medical library staff to conduct keyword searches for "Silicone," "Renal failure," "Silicone emboli syndrome," "Silicone granuloma," and "Silicone end organ toxicity." The search results were reviewed by the authors and selected based on the relevance to the case report presented. Extensive literature relating to silicone granulomas and their systemic effects supports the use of steroids for immediate treatment and eventual surgical resection for cure of the various silicone-related end-organ toxicities including renal failure.

  19. [Pedicled superior gluteal artery perforator bilateral quadrilobed flaps for repair of large sacrococcygeal pressure sores].

    Science.gov (United States)

    Hai, Henglin; Li, Huatao; Chen, Yang; Li, Qiang; Wu, Shenggang; Lili, Wang; Yan, Lei; Xiaoying, Zhou

    2013-03-01

    To investigate the effectiveness of pedicled superior gluteal artery perforator bilateral quadrilobed flaps for repairing large sacrococcygeal pressure sores. Between June 2003 and August 2011, 6 paraplegia patients with large sacrococcygeal pressure sores were repaired with the pedicled superior gluteal artery perforator bilateral quadrilobed flaps. There were 2 males and 4 females with an average age of 45.6 years (range, 37-62 years). The mean disease duration was 8.4 months (range, 3-26 months). According to National Pressure Ulcer Advisory Panel (NPUAP) standard, 6 cases rated as degree IV. The size of pressure sores ranged from 15 cm x 13 cm to 18 cm x 16 cm. The size of flaps ranged from 18 cm x 14 cm to 21 cm x 15 cm. After operation, all flaps survived successfully. The wounds healed by first intention in 5 cases; partial dehiscence of incision occurred in 1 case, which was cured after dressing change for 26 days. Six patients were followed up 6-24 months (mean, 12.5 months). The appearance and texture of the flaps were smooth and soft with good elasticity and no ulceration. Pedicled superior gluteal artery perforator bilateral quadrilobed flaps can repair large sacrococcygeal pressure sores. The appearance of flaps is smooth and has good compression-resistance effect.

  20. Successful Treatment of Gluteal Pain from Obturator Internus Tendinitis and Bursitis with Ultrasound-Guided Injection.

    Science.gov (United States)

    Chen, Boqing; Rispoli, Leia; Stitik, Todd; Leong, Michelle

    2017-10-01

    This case report describes what the authors believe is the first case of a patient with obturator internus tendinitis and bursitis successfully treated with a corticosteroid injection using a trans-tendinous lateral to medial approach. The patient presented with right gluteal pain not relieved by physical therapy or right hip and ischial bursa corticosteroid injections. Pelvic and lumbar spine MRIs and EMG/NCS findings were unremarkable. Physical examination demonstrated tenderness to palpation at the right middle lower gluteal region. Ultrasound imaging with sonopalpation identified the maximal local tender point as the right obturator internus muscle and/or its underlying bursa. A 22-gauge 3.5-inch needle was inserted in-plane to the transducer and longitudinal to the obturator internus from a lateral to medial direction, an approach previously described in cadavers. The obturator internus tendon sheath and bursa were injected with 2.5 ml of 0.5% lidocaine combined with 10 mg of triamcinolone. The patient reported immediate complete relief of pain with continued relief at 2 and 6 months post-injection. This case report demonstrates an injection of the obturator internus tendon sheath and bursa using a trans-tendinous approach, which may be successful for treatment of patients presenting with persistent gluteal pain from obturator internus tendinitis and bursitis.

  1. Gluteal Black Market Silicone–induced Renal Failure: A Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Andrea Matson, DO, PGY-2

    2017-11-01

    Full Text Available Summary:. Very few cases of successful surgical treatment for renal failure due to gluteal silicone injections have been reported in the literature. The silicone toxicity and subsequent renal failure seem to follow repetitive silicone injections and silicone injections in large quantities. This is a case of a 31-year-old woman who developed renal failure after 6 years of gluteal silicone injections who underwent radical resection of bilateral gluteal regions in an attempt to mitigate her impending complete renal failure. A systematic review of the literature was conducted using PubMed database and with assistance from medical library staff to conduct keyword searches for “Silicone,” “Renal failure,” “Silicone emboli syndrome,” “Silicone granuloma,” and “Silicone end organ toxicity.” The search results were reviewed by the authors and selected based on the relevance to the case report presented. Extensive literature relating to silicone granulomas and their systemic effects supports the use of steroids for immediate treatment and eventual surgical resection for cure of the various silicone-related end-organ toxicities including renal failure.

  2. The Use of Magnetic Resonance Imaging in Planning a Pedicled Perforator Flap for Pressure Sores in the Gluteal Region.

    Science.gov (United States)

    Park, Sun-June; Lee, Kyeong-Tae; Jeon, Byung-Joon; Woo, Kyong-Je

    2018-04-01

    Pedicled perforator flaps (PPFs) have been widely used to treat pressure sores in the gluteal region. Selection of a reliable perforator is crucial for successful surgical treatment of pressure sores using PPFs. In this study, we evaluate the role of magnetic resonance imaging (MRI) in planning PPF reconstruction of pressure sores in the gluteal region. A retrospective chart review was performed in patients who had undergone these PPF reconstructions and who had received preoperative MRI. Preoperatively, the extent of infection and necrotic tissue was evaluated using MRI, and a reliable perforator was identified, considering the perforator location in relation to the defect, perforator size, and perforator courses. Intraoperatively, the targeted perforator was marked on the skin at the locations measured on the MRI images, and the marked location was confirmed using intraoperative handheld Doppler. Superior gluteal artery, inferior gluteal artery, or parasacral perforators were used for the PPFs. Surgical outcomes were evaluated. A total of 12 PPFs were performed in 12 patients. Superior gluteal artery perforator flaps were performed in 7 patients, inferior gluteal artery perforator flaps were performed in 3 patients, and parasacral perforator flaps were performed in 2 patients. We could identify a reliable perforator on MRI, and it was found at the predicted locations in all cases. There was only one case of partial flap necrosis. There was no recurrence of the pressure sores during the mean follow-up period of 6.7 months (range = 3-15 months). In selected patients with gluteal pressure sores, MRI is a suitable means for not only providing information about disease extent and comorbidities but also for evaluating perforators for PPF reconstructions.

  3. Inferior gluteal artery perforator flap: a viable alternative for ischial pressure sores.

    Science.gov (United States)

    Kim, Young Seok; Lew, Dae Hyun; Roh, Tai Suk; Yoo, Won Min; Lee, Won Jai; Tark, Kwan Chul

    2009-10-01

    The ischial area is by far the most common site for pressure sores in wheelchair-bound paraplegic patients, because most of the pressure of the body is exerted on this area in the seated position. Even after a series of successful pressure sore treatments, the site is very prone to relapse from the simplest everyday tasks. Therefore, it is crucial to preserve the main pedicle during primary surgery. Several surgical procedures, such as myocutaneous flap and perforator flap, have been introduced for the treatment of pressure sores. During a 4-year time period at our institute, we found favourable clinical results using the inferior gluteal artery perforator (IGAP) procedure for ischial sore treatment. A total of 23 patients (20 males and three females) received IGAP flap surgery in our hospital from January 2003 to January 2007. Surgery was performed on the same site again in 10 (43%) patients who had originally relapsed after undergoing the conventional method of pressure sore surgery. The average age of patients was 47.4 years (range 26-71 years). Most of the patients were paraplegic (16 cases, 70%) and others were either quadriplegic (four cases, 17%) or ambulatory (three cases, 13%). Based on hospital records and clinical photographs, we attempted to assess the feasibility and practicability of the IGAP flap procedure through comparative analysis of several parameters including the size of the defective area, treatment modalities, relapses, complications, and postoperative treatments. The average follow-up duration for 23 subjects was 25.4 months (range 5-42 months). All flaps survived without major complications. Partial flap necrosis developed in one case but secondary healing was achieved and the final outcome was not impaired. Most of the cases healed well during the follow-up period. Postoperative complications such as wound dehiscence and fistula developed in some subjects, but all healed well with a secondary treatment. A total of five cases relapsed

  4. The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

    Science.gov (United States)

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

    2013-04-01

    To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

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

    Science.gov (United States)

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

    2016-02-18

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

  6. Arteriovenous fistula of the superior gluteal artery as a complication of posterior iliac crest bone graft harvesting: 3D-CT angiography and arterial embolization

    OpenAIRE

    Kong, Chae-Gwan; Park, Jong-Beom; Won, Yoo-Dong; Riew, K. Daniel

    2009-01-01

    Superior gluteal artery injuries are rare, but potentially serious complications that occur during posterior iliac crest bone graft harvesting. The authors reported an arteriovenous fistula of the superior gluteal artery, which occurred as a complication during posterior iliac crest bone graft harvesting and was diagnosed with 3D-CT angiography, then treated with arterial embolization.

  7. Clinical trial to compare tinnitus masking and tinnitus retraining therapy.

    Science.gov (United States)

    Henry, J A; Schechter, M A; Zaugg, T L; Griest, S; Jastreboff, P J; Vernon, J A; Kaelin, C; Meikle, M B; Lyons, K S; Stewart, B J

    2006-12-01

    Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a 'moderate' and 'big' problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a 'very big' problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

  8. Non-small-cell lung cancer: unusual presentation in the gluteal muscle.

    LENUS (Irish Health Repository)

    Al-Alao, Bassel Suffian

    2011-05-01

    Lung cancer is one of the most commonly diagnosed cancers in both men and women worldwide. It is also one of the most common forms of cancer in Ireland, accounting for about 20% of all deaths from cancer each year. Early detection of lung cancer is infrequent, and most cases are not diagnosed and treated until they are at an advanced stage. Distant metastases in lung cancer commonly involve the adrenal glands, liver, bones, and central nervous system; they are only rarely seen in the skeletal system. We report a rare case of metastasis to the gluteal muscle as the initial presentation of lung cancer.

  9. Gluteal mass in a bodybuilder: radiological depiction of a complication of anabolic steroid use

    Energy Technology Data Exchange (ETDEWEB)

    Al-Ismail, Khalid; Torreggiani, William C; Munk, Peter L; Nicolaou, Savvas [Department of Radiology, Vancouver General Hospital and the University of British Columbia, Vancouver, BC (Canada)

    2002-06-01

    The use of anabolic steroids by bodybuilders is relatively common and associated with many side effects. Local side effects include tissue necrosis and soft tissue infection at the injection site. Systemic effects may be early epiphyseal closure in the immature skeleton, testicular atrophy, sterility, acne, gynaecomastia and liver disorders such as hepatitis. We report an unusual case of a bodybuilder who developed a large painful inflammatory soft tissue mass in his gluteal area. Multi-modality imaging showed direct evidence revealing the underlying cause of the mass being depot steroid injections. (orig.)

  10. Damage to the superior gluteal nerve after the Hardinge approach to the hip.

    LENUS (Irish Health Repository)

    Ramesh, M

    2012-02-03

    We studied prospectively 81 consecutive patients undergoing hip surgery using the Hardinge (1982) approach. The abductor muscles of the hip in these patients were assessed electrophysiologically and clinically by the modified Trendelenburg test. Power was measured using a force plate. We performed assessment at two weeks, and at three and nine months after operation. At two weeks we found that 19 patients (23%) showed evidence of damage to the superior gluteal nerve. By three months, five of these had recovered. The nine patients with complete denervation at three months showed no signs of recovery when reassessed at nine months. Persistent damage to the nerve was associated with a positive Trendelenburg test.

  11. Gluteal mass in a bodybuilder: radiological depiction of a complication of anabolic steroid use

    International Nuclear Information System (INIS)

    Al-Ismail, Khalid; Torreggiani, William C.; Munk, Peter L.; Nicolaou, Savvas

    2002-01-01

    The use of anabolic steroids by bodybuilders is relatively common and associated with many side effects. Local side effects include tissue necrosis and soft tissue infection at the injection site. Systemic effects may be early epiphyseal closure in the immature skeleton, testicular atrophy, sterility, acne, gynaecomastia and liver disorders such as hepatitis. We report an unusual case of a bodybuilder who developed a large painful inflammatory soft tissue mass in his gluteal area. Multi-modality imaging showed direct evidence revealing the underlying cause of the mass being depot steroid injections. (orig.)

  12. A randomised controlled trial comparing the effect of adjuvant ...

    African Journals Online (AJOL)

    Background: Intrathecal adjuvants are added to local anaesthetics to improve the quality of neuraxial blockade and prolong the duration of analgesia during spinal anaesthesia. Used intrathecally, fentanyl improves the quality of spinal blockade as compared to plain bupivacaine and confers a short duration of post ...

  13. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    Walid Galal Elshazly

    2011-12-03

    Dec 3, 2011 ... sure, advancement flap (Karydakis procedure), local advance- ment flap (V-Y advancement flap), and rotational flap. (Limberg flap, modified Limberg flap, gluteus maximus myo- cutaneous flap).5,6. However, there have been few clinical studies to compare the rhomboid fasciocutaneous transposition flap ...

  14. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    The aim of this study was to compare modified Limberg flap procedure with excision and primary closure in the treatment of uncomplicated pilonidal disease. Methods: This study was conducted on 120 patients with uncomplicated sacrococcygeal pilonidal disease that were randomly allocated into two groups: group I ...

  15. Pain Relief in Labor: A Randomized Controlled Trial Comparing ...

    African Journals Online (AJOL)

    Conclusions: This study showed that 600 mg intramuscular paracetamol provides similar and modest pain relief in labor when compared to 100 mg intramuscular tramadol. It also has fewer maternal adverse effects and favorable neonatal outcome such as tramadol. It is concluded that intramuscular paracetamol is simple, ...

  16. PRIVATE MANUFACTURERS’ THRESHOLDS TO INVEST IN COMPARATIVE EFFECTIVENESS TRIALS

    OpenAIRE

    Basu, Anirban; Meltzer, David

    2012-01-01

    The recent rush of enthusiasm for public investment in comparative effectiveness research (CER) in the United States has focused attention on these public investments. However, little attention has been given to how changing public investment in CER may affect private manufacturers’ incentives for CER, which has long been a major source of CER. In this work, based on a simple revenue maximizing economic framework, we generate predictions on thresholds to invest in CER for a private manufactur...

  17. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

  18. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Gershkovich, Pavel; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2016-12-01

    The maximum plasma concentration (C max ) and the area under the plasma concentration-time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.

  19. Trial of Labor Compared With Cesarean Delivery in Superobese Women.

    Science.gov (United States)

    Grasch, Jennifer L; Thompson, Jennifer L; Newton, J Michael; Zhai, Amy W; Osmundson, Sarah S

    2017-11-01

    To examine whether labor compared with planned cesarean delivery is associated with increased maternal and neonatal morbidity. We conducted a retrospective cohort study of all women with body mass indexes (BMIs) at delivery of 50 or greater delivering a live fetus at 34 weeks of gestation of greater between January 1, 2008, and December 31, 2015. Pregnancies with multiple gestations and major fetal anomalies were excluded. The primary outcome was a composite of maternal and neonatal morbidity and was estimated to be 50% in superobese women based on institutional data. A sample size of 338 women determined the study period and was selected to show a 30% difference in the incidence of the primary outcome between the two groups. Multivariate logistic regression adjusted for potential confounders. There were 344 women with BMIs of 50 or greater who met eligibility criteria, of whom 201 (58%) labored and 143 (42%) underwent planned cesarean delivery. Women who labored were younger, more likely to be nulliparous, and less likely to have pre-existing diabetes. Among women who labored, 45% underwent a cesarean delivery, most commonly for labor arrest (61%) or nonreassuring fetal status (28%). Composite maternal and neonatal morbidity was reduced among women who labored even after adjusting for age, parity, pre-existing diabetes, and prior cesarean delivery (adjusted odds ratio 0.42, 95% CI 0.24-0.75). In the subgroup of women (n=234) who underwent a cesarean delivery, whether planned (n=143) or after labor (n=91), there were no differences in maternal and neonatal morbidity except that severe maternal morbidity was increased in women (n=12) who labored (8.8% compared with 2.1%, relative risk 4.2, 95% CI 1.14-15.4). Despite high rates of cesarean delivery in women with superobesity, labor is associated with lower composite maternal and neonatal morbidity. Severe maternal morbidity may be higher in women who require a cesarean delivery after labor.

  20. Iliopsoas and Gluteal Muscles Are Asymmetric in Tennis Players but Not in Soccer Players

    Science.gov (United States)

    Sanchis-Moysi, Joaquin; Idoate, Fernando; Izquierdo, Mikel; Calbet, Jose A. L.; Dorado, Cecilia

    2011-01-01

    Purpose To determine the volume and degree of asymmetry of iliopsoas (IL) and gluteal muscles (GL) in tennis and soccer players. Methods IL and GL volumes were determined using magnetic resonance imaging (MRI) in male professional tennis (TP) and soccer players (SP), and in non-active control subjects (CG) (n = 8, 15 and 6, respectively). Results The dominant and non-dominant IL were hypertrophied in TP (24 and 36%, respectively, Psoccer players had similar volumes in both sides (P = 0.87). The degree of side-to-side asymmetry decreased linearly from the first lumbar disc to the pubic symphysis in TP (r = −0.97, PSoccer and CG had similar GL volumes in both sides (P = 0.11 and P = 0.19, for the dominant and contralateral GL, respectively). GL was asymmetrically hypertrophied in TP. The non-dominant GL volume was 20% greater in TP than in CG (Psoccer is associated to a symmetric hypertrophy of IL. Gluteal muscles are asymmetrically hypertrophied in TP, while SP display a similar size to that observed in controls. It remains to be determined whether the different patterns of IL and GL hypertrophy may influence the risk of injury. PMID:21829539

  1. The decision to conduct a head-to-head comparative trial: a game-theoretic analysis.

    Science.gov (United States)

    Mansley, Edward C; Elbasha, Elamin H; Teutsch, Steven M; Berger, Marc L

    2007-01-01

    Recent Medicare legislation calls on the Agency for Healthcare Research and Quality to conduct research related to the comparative effectiveness of health care items and services, including prescription drugs. This reinforces earlier calls for head-to-head comparative trials of clinically relevant treatment alternatives. Using a game-theoretic model, the authors explore the decision of pharmaceutical companies to conduct such trials. The model suggests that an important factor affecting this decision is the potential loss in market share and profits following a result of inferiority or comparability. This hidden cost is higher for the market leader than the market follower, making it less likely that the leader will choose to conduct a trial. The model also suggests that in a full-information environment, it will never be the case that both firms choose to conduct such a trial. Furthermore, if market shares and the probability of proving superiority are similar for both firms, it is quite possible that neither firm will choose to conduct a trial. Finally, the results indicate that incentives that offset the direct cost of a trial can prevent a no-trial equilibrium, even when both firms face the possibility of an inferior outcome.

  2. Randomized Controlled Trial Comparing Daycare and Overnight Stay Laparoscopic Cholecystectomy.

    Science.gov (United States)

    Salleh, A A M; Affirul, C A; Hairol, O; Zamri, Z; Azlanudin, A; Hilmi, M A; Razman, J

    2015-01-01

    This present study sought to review the feasibility and patients' satisfaction of laparoscopic cholecystectomy to be perform as daycare procedure. Sixty-two patients with symptomatic gallstones were recruited within a year. They were randomized into overnight stay and daycare groups. The outcomes and post-operative complications were analyzed. Fifty-eight patients were eligible for analysis and four patients were excluded because of conversion to open cholecystectomy. All patients in daycare group reported no fever but two patients in the overnight stay group complaint of post-operative fever (p=0.150). The mean pain score using Visual Analogue Score (VAS) in daycare group was 2.93 but in the overnight stay was recorded as 3.59 (p=0.98). Five patients had post-operative nausea and vomiting (PONV) in daycare group compared to 2 patients in the overnight stay group (p=0.227). Patient's satisfaction were higher in the daycare group (p=0.160). All patients in daycare group were back at work within a week but in overnight stay, 11 patients had to stay off work for more than one week (p=0.01). Daycare laparoscopic cholecystectomy is safe and feasible. The satisfaction of daycare surgery is higher than overnight stay group. Patients' selection is an important aspect of its success.

  3. Electrical stimulation-induced Gluteal and Hamstring muscle activation can reduce sitting pressure in individuals with a spinal cord injury

    NARCIS (Netherlands)

    Janssen, T. W J; De Koning, A.; Legemate, K. J A; Smit, C. A J

    2010-01-01

    Individuals with spinal cord injury (SCI) are at high risk of developing pressure sores, in part due to high sitting pressures under the buttocks. PURPOSE: To evaluate the effect of ES-induced activation of the gluteal and hamstring muscles on the sitting pressure in individuals with SCI. METHODS:

  4. The surgical anatomy of the superior gluteal nerve and anatomical radiologic bases of the direct lateral approach to the hip

    NARCIS (Netherlands)

    J.C. Bos (Jan); R. Stoeckart (Rob); A. Klooswijk (Aij); B. van Linge (Bert); R. Bahadoer (R.)

    1994-01-01

    textabstractIn view of the increasing popularity of the direct lateral approach to the hip joint for hemi- or total hip arthroplasty, the location of the superior gluteal nerve (SGN) was studied. This nerve is in danger when using a transgluteal incision. In 20 embalmed specimens the relation of the

  5. A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

    Science.gov (United States)

    Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

    2017-01-01

    Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…

  6. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  7. Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

    Science.gov (United States)

    Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

  8. Surgical approach to extensive hidradenitis suppurativa in the perineal/perianal and gluteal regions.

    Science.gov (United States)

    Balik, Emre; Eren, Tunc; Bulut, Türker; Büyükuncu, Yilmaz; Bugra, Dursun; Yamaner, Sümer

    2009-03-01

    Verneuil's disease, or hidradenitis suppurativa, is a chronic suppurative disease with a tendency to sinus formation, fibrosis, and sclerosis. It is a disease of the apocrine sweat glands and may arise from each of the localizations where apocrine glands are prominent: axilla, nipples, umbilicus, perineum, groin, and buttocks. Extensive hidradenitis suppurativa of the perineal/perianal and the gluteal regions constitute a serious social problem. In this study, we present our experience with stage III extensive hidradenitis suppurativa cases, including our treatment methods and patient outcomes. A retrospective review of the medical records from January 1990 to July 2003 of 15 patients was performed. Fifteen patients underwent treatment for extensive hidradenitis suppurativa in the gluteal, perineal/perianal, and inguinal areas with total surgical excision. All patients were men (100%) and their mean age was 42.5 (range, 23-66) years. The patients underwent a total number of 21 operations. In 11 patients wounds were left open for secondary healing, and the mean time for complete wound healing in this group was 12.2 (range, 9.5-22) weeks. Two patients underwent primary wound closure by the application of rotation flaps, and their complete healing times were observed to be approximately 2 weeks. Delayed skin grafting was used for the remaining two patients in whom the wounds had been left open after the initial operation. In this group, complete wound healing took a total of 8 weeks. Only one diverting colostomy was needed in a patient in the delayed skin-grafting group. Squamous cell carcinoma was diagnosed in the specimens of one patient treated with total excision followed by the application of a rotation flap. This patient had had complaints of gluteal discharge for approximately 30 years. The cancer recurred after 6 months in the perianal region and immediate abdominoperineal resection was performed. He died during the second postoperative month due to systemic

  9. Digital subtraction angiography of inferior gluteal artery through the infusion catheter of chemotherapy for bladder cancer

    International Nuclear Information System (INIS)

    Ishikawa, Satoru; Noguchi, Ryosuke; Kanoh, Shori; Shimazui, Toru; Uchida, Katsunori; Nemoto, Ryosuke; Koiso, Kenkichi

    1987-01-01

    More than fifty patients of invasive bladder cancer had been treated by selective intra-arterial chemotherapy through the inferior or superior gluteal arteries. The distribution of infused drugs had been evaluated by RI-angiography through a thin arterial infusion catheter. This time we performed digital subtraction angiography (DSA) through an infusion catheter in order to know the precise distribution of infused materials in seven patients with locally advanced bladder cancer. Pharmaco-DSA with norepinephrine was also done in four patients. Satisfactory spatial and contrast resolution were gained in four patients and pharmaco-DSA showed better quality. In our experience DSA through intra-arterial infusion catheter was a useful procedure in the evaluation of distribution of infused drugs. (author)

  10. Deep gluteal syndrome: anatomy, imaging, and management of sciatic nerve entrapments in the subgluteal space

    International Nuclear Information System (INIS)

    Hernando, Moises Fernandez; Cerezal, Luis; Perez-Carro, Luis; Abascal, Faustino; Canga, Ana

    2015-01-01

    Deep gluteal syndrome (DGS) is an underdiagnosed entity characterized by pain and/or dysesthesias in the buttock area, hip or posterior thigh and/or radicular pain due to a non-discogenic sciatic nerve entrapment in the subgluteal space. Multiple pathologies have been incorporated in this all-included ''piriformis syndrome,'' a term that has nothing to do with the presence of fibrous bands, obturator internus/gemellus syndrome, quadratus femoris/ischiofemoral pathology, hamstring conditions, gluteal disorders and orthopedic causes. The concept of fibrous bands playing a role in causing symptoms related to sciatic nerve mobility and entrapment represents a radical change in the current diagnosis of and therapeutic approach to DGS. The development of periarticular hip endoscopy has led to an understanding of the pathophysiological mechanisms underlying piriformis syndrome, which has supported its further classification. A broad spectrum of known pathologies may be located nonspecifically in the subgluteal space and can therefore also trigger DGS. These can be classified as traumatic, iatrogenic, inflammatory/infectious, vascular, gynecologic and tumors/pseudo-tumors. Because of the ever-increasing use of advanced magnetic resonance neurography (MRN) techniques and the excellent outcomes of the new endoscopic treatment, radiologists must be aware of the anatomy and pathologic conditions of this space. MR imaging is the diagnostic procedure of choice for assessing DGS and may substantially influence the management of these patients. The infiltration test not only has a high diagnostic but also a therapeutic value. This article describes the subgluteal space anatomy, reviews known and new etiologies of DGS, and assesses the role of the radiologist in the diagnosis, treatment and postoperative evaluation of sciatic nerve entrapments, with emphasis on MR imaging and endoscopic correlation. (orig.)

  11. Deep gluteal syndrome: anatomy, imaging, and management of sciatic nerve entrapments in the subgluteal space

    Energy Technology Data Exchange (ETDEWEB)

    Hernando, Moises Fernandez; Cerezal, Luis; Perez-Carro, Luis; Abascal, Faustino; Canga, Ana [Diagnostico Medico Cantabria (DMC), Department of Radiology, Santander, Cantabria (Spain); Valdecilla University Hospital, Orthopedic Surgery Department Clinica Mompia (L.P.C.), Santander, Cantabria (Spain); Valdecilla University Hospital, Department of Radiology, Santander, Cantabria (Spain)

    2015-03-05

    Deep gluteal syndrome (DGS) is an underdiagnosed entity characterized by pain and/or dysesthesias in the buttock area, hip or posterior thigh and/or radicular pain due to a non-discogenic sciatic nerve entrapment in the subgluteal space. Multiple pathologies have been incorporated in this all-included ''piriformis syndrome,'' a term that has nothing to do with the presence of fibrous bands, obturator internus/gemellus syndrome, quadratus femoris/ischiofemoral pathology, hamstring conditions, gluteal disorders and orthopedic causes. The concept of fibrous bands playing a role in causing symptoms related to sciatic nerve mobility and entrapment represents a radical change in the current diagnosis of and therapeutic approach to DGS. The development of periarticular hip endoscopy has led to an understanding of the pathophysiological mechanisms underlying piriformis syndrome, which has supported its further classification. A broad spectrum of known pathologies may be located nonspecifically in the subgluteal space and can therefore also trigger DGS. These can be classified as traumatic, iatrogenic, inflammatory/infectious, vascular, gynecologic and tumors/pseudo-tumors. Because of the ever-increasing use of advanced magnetic resonance neurography (MRN) techniques and the excellent outcomes of the new endoscopic treatment, radiologists must be aware of the anatomy and pathologic conditions of this space. MR imaging is the diagnostic procedure of choice for assessing DGS and may substantially influence the management of these patients. The infiltration test not only has a high diagnostic but also a therapeutic value. This article describes the subgluteal space anatomy, reviews known and new etiologies of DGS, and assesses the role of the radiologist in the diagnosis, treatment and postoperative evaluation of sciatic nerve entrapments, with emphasis on MR imaging and endoscopic correlation. (orig.)

  12. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  13. Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy

    NARCIS (Netherlands)

    Moonen, A.; Busch, O.; Costantini, M.; Finotti, E.; Tack, J.; Salvador, R.; Boeckxstaens, G.; Zaninotto, G.

    2017-01-01

    BackgroundA recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present

  14. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

  15. Albendazole versus praziquantel in the treatment of neurocysticercosis: a meta-analysis of comparative trials.

    Directory of Open Access Journals (Sweden)

    Dimitrios K Matthaiou

    Full Text Available BACKGROUND: Neurocysticercosis, infection of the brain with larvae of Taenia solium (pork tapeworm, is one of several forms of human cysticercosis caused by this organism. We investigated the role of albendazole and praziquantel in the treatment of patients with parenchymal neurocysticercosis by performing a meta-analysis of comparative trials of their effectiveness and safety. METHODS AND PRINCIPAL FINDINGS: We performed a search in the PubMed database, Cochrane Database of Controlled Trials, and in references of relevant articles. Six studies were included in the meta-analysis. Albendazole was associated with better control of seizures than praziquantel in the pooled data analysis, when the generic inverse variance method was used to combine the incidence of seizure control in the included trials (patients without seizures/[patients x years at risk] (156 patients in 4 studies, point effect estimate [incidence rate ratio] = 4.94, 95% confidence interval 2.45-9.98. In addition, albendazole was associated with better effectiveness than praziquantel in the total disappearance of cysts (335 patients in 6 studies, random effects model, OR = 2.30, 95% CI 1.06-5.00. There was no difference between albendazole and praziquantel in reduction of cysts, proportion of patients with adverse events, and development of intracranial hypertension due to the administered therapy. CONCLUSIONS: A critical review of the available data from comparative trials suggests that albendazole is more effective than praziquantel regarding clinically important outcomes in patients with neurocysticercosis. Nevertheless, given the relative scarcity of trials, more comparative interventional studies--especially randomized controlled trials--are required to draw a safe conclusion about the best regimen for the treatment of patients with parenchymal neurocysticercosis.

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

    Science.gov (United States)

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

    2015-01-01

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

  17. Intraoperative indocyanine green fluorescent angiography-assisted modified superior gluteal artery perforator flap for reconstruction of sacral pressure sores.

    Science.gov (United States)

    Chang, Chun-Kai; Wu, Chien-Ju; Chen, Chun-Yu; Wang, Chi-Yu; Chu, Tzi-Shiang; Hsu, Kuo-Feng; Chiu, Han-Ting; Liu, Hung-Hui; Chou, Chang-Yi; Wang, Chih-Hsin; Lin, Chin-Ta; Dai, Niann-Tzyy; Tzeng, Yuan-Sheng

    2017-12-01

    Pressure sores are often observed in patients who are bedridden. They can be a severe problem not only for patients and their caregivers but also for plastic surgeons. Here, we describe a new method of superior gluteal artery perforator flap harvesting and anchoring with the assistance of intraoperative indocyanine green fluorescent angiography. In this report, we describe the procedure and outcomes for 19 patients with grades III and IV sacral pressure sores who underwent the operation between September 2015 and November 2016. All flaps survived, and two experienced wound-edge partial dehiscence. With the assistance of this imaging device, we were able to acquire a reliable superior gluteal artery perforator flap and perform modified operations with it that are safe, easy to learn and associated with fewer complications than are traditional. © 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

  18. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  19. Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

    OpenAIRE

    Williams, N S; Johnston, D

    1980-01-01

    Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complicati...

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

    OpenAIRE

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

    2014-01-01

    Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and qu...

  1. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials

    OpenAIRE

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2010-01-01

    ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...

  2. The effect of a trunk release maneuver on Peak Pressure Index, trunk displacement and perceived discomfort in older adults seated in a High Fowler's position: a randomized controlled trial.

    Science.gov (United States)

    Best, Krista L; Desharnais, Guylaine; Boily, Jeanette; Miller, William C; Camp, Pat G

    2012-11-16

    Pressure ulcers pose significant negative individual consequences and financial burden on the healthcare system. Prolonged sitting in High Fowler's position (HF) is common clinical practice for older adults who spend extended periods of time in bed. While HF aids in digestion and respiration, being placed in a HF may increase perceived discomfort and risk of pressure ulcers due to increased pressure magnitude at the sacral and gluteal regions. It is likely that shearing forces could also contribute to risk of pressure ulcers in HF. The purpose of this study was to evaluate the effect of a low-tech and time-efficient Trunk Release Manuever (TRM) on sacral and gluteal pressure, trunk displacement and perceived discomfort in ambulatory older adults. A randomized controlled trial was used. We recruited community-living adults who were 60 years of age and older using posters, newspaper advertisements and word-of-mouth. Participants were randomly allocated to either the intervention or control group. The intervention group (n = 59) received the TRM, while the control group (n = 58) maintained the standard HF position. The TRM group had significantly lower mean (SD) PPI values post-intervention compared to the control group, 59.6 (30.7) mmHg and 79.9 (36.5) mmHg respectively (p = 0.002). There was also a significant difference in trunk displacement between the TRM and control groups, +3.2 mm and -5.8 mm respectively (p = 0.005). There were no significant differences in perceived discomfort between the groups. The TRM was effective for reducing pressure in the sacral and gluteal regions and for releasing the trunk at the point of contact between the skin and the support surface, but did not have an effect on perceived discomfort. The TRM is a simple method of repositioning which may have important clinical application for the prevention of pressure ulcers that may occur as a result of HF.

  3. Iliac hyperdense line: a new radiographic sign of gluteal muscle contracture

    Energy Technology Data Exchange (ETDEWEB)

    Cai, Jin-Hua; Gan, Lan-Feng; Zheng, He-Lin; Li, Hao [Chongqing Medical University, Department of Radiology, Children' s Hospital, Chongqing (China)

    2005-10-01

    A hyperdense line on the ilium that runs roughly parallel to the sacroiliac joint (we called it ''iliac hyperdense line sign'') was frequently observed on pelvic radiographs of patients with gluteal muscle contracture (GMC). A literature search revealed no description of this sign. To determine the relationship between the iliac hyperdense line sign and GMC and to explore how this sign is formed. Pelvic plain films of 103 cases of GMC and those of 200 control individuals were reviewed for the presence or absence of the iliac hyperdense line sign. Pelvic CT scans in 8 of 103 cases and 13 of 200 controls were analyzed with relation to the plain films. The iliac hyperdense line sign was visualized in 85 of 103 (82.5%) cases of GMC and none of the 200 controls. In the GMC group, pelvic CT scans showed a deformity of the posterior ilium. The lateral cortex of the posterior ilium took on a partly or completely anteroposterior course, while in the control group the course appeared as an oblique orientation from posteromedial to anterolateral. The iliac hyperdense line on pelvic plain film can be used as a radiographic sign to suggest a diagnosis of GMC. This sign might be a result of the long and persistent pulling effect of the contracted gluteus maximus muscle, which deforms the lateral cortex of the posterior ilium from an oblique course to an anteroposterior course tangential to the X-ray beam. (orig.)

  4. Iliac hyperdense line: a new radiographic sign of gluteal muscle contracture

    International Nuclear Information System (INIS)

    Cai, Jin-Hua; Gan, Lan-Feng; Zheng, He-Lin; Li, Hao

    2005-01-01

    A hyperdense line on the ilium that runs roughly parallel to the sacroiliac joint (we called it ''iliac hyperdense line sign'') was frequently observed on pelvic radiographs of patients with gluteal muscle contracture (GMC). A literature search revealed no description of this sign. To determine the relationship between the iliac hyperdense line sign and GMC and to explore how this sign is formed. Pelvic plain films of 103 cases of GMC and those of 200 control individuals were reviewed for the presence or absence of the iliac hyperdense line sign. Pelvic CT scans in 8 of 103 cases and 13 of 200 controls were analyzed with relation to the plain films. The iliac hyperdense line sign was visualized in 85 of 103 (82.5%) cases of GMC and none of the 200 controls. In the GMC group, pelvic CT scans showed a deformity of the posterior ilium. The lateral cortex of the posterior ilium took on a partly or completely anteroposterior course, while in the control group the course appeared as an oblique orientation from posteromedial to anterolateral. The iliac hyperdense line on pelvic plain film can be used as a radiographic sign to suggest a diagnosis of GMC. This sign might be a result of the long and persistent pulling effect of the contracted gluteus maximus muscle, which deforms the lateral cortex of the posterior ilium from an oblique course to an anteroposterior course tangential to the X-ray beam. (orig.)

  5. Effect of controlled exercise on middle gluteal muscle fibre composition in Thoroughbred foals.

    Science.gov (United States)

    Eto, D; Yamano, S; Kasashima, Y; Sugiura, T; Nasu, T; Tokuriki, M; Miyata, H

    2003-11-01

    Most racehorses are trained regularly from about age 18 months; therefore, little information is available on the effect of training in Thoroughbred foals. Well-controlled exercise could improve muscle potential ability for endurance running. Thoroughbred foals at age 2 months were separated into control and training (treadmill exercise) groups and samples obtained from the middle gluteal muscle at 2 and 12 months post partum. Muscle fibre compositions were determined by histochemical and electrophoretical techniques and succinic dehydrogenase (SDH) activity was analysed in each fibre type. All fibre types were hypertrophied with growth and type I and IIA fibres were significantly larger in the training than the control group at age 12 months. A significant increase of SDH activity was found in type IIX muscle fibres in the training group. Training in young Thoroughbred horses can facilitate muscle fibre hypertrophy and increase the oxidative capacity of type IIX fibres, which could potentially enhance stamina at high speeds. To apply this result to practical training, further studies are needed to determine more effective and safe intensities of controlled exercise.

  6. Iliac hyperdense line: a new X-ray sign of gluteal muscle contracture

    International Nuclear Information System (INIS)

    Cai Jinhua; Gan Lanfeng; Zheng Helin; He Ling; Yu Guorong

    2003-01-01

    Objective: To elucidate the relationship between gluteal muscle contracture (GMC) and the iliac hyperdense line on pelvic plain film, and to explore how the iliac hyperdense line is formed. Methods: The pelvic plain films of 103 cases with GMC confirmed by operation and those of 200 individuals as control were analyzed. Pelvic CT scanning was performed in 8 cases GMC and 13 cases of normal controls. Results: The iliac hyperdense line at the side of sacroiliac joint was found on the pelvic plain film in 85 of 103 cases with GMC and 5 of 200 in control group. In 103 cases of GMC, the iliac hyperdense line was detected in 81 of 88 patients beyond 5 years, and 83 of 94 was mostly the gluteus maximus contracture. In control group, pelvic CT showed that the outer cortex of posterior ilium at the level of sacroiliac joint appeared as an oblique plane, oriented from posteromedial side to anterolateral side, while in GMC group, the oblique plane became steeper and almost oriented posteroanteriorly. In addition, the posterior part of the ilium which gave the attachment of contracted gluteus maximus muscle deformed and widened. Conclusion: The iliac hyperdense line on the pelvic plain film is resulted from the long and persistent pulling effect of contracted gluteus maximus muscle, which causes the change the oblique plane of posterior ilium into a posteroanterior course parallel to the X-ray beam

  7. Relationship between gluteal muscle activation and upper extremity kinematics and kinetics in softball position players.

    Science.gov (United States)

    Oliver, Gretchen D

    2014-03-01

    As the biomechanical literature concerning softball pitching is evolving, there are no data to support the mechanics of softball position players. Pitching literature supports the whole kinetic chain approach including the lower extremity in proper throwing mechanics. The purpose of this project was to examine the gluteal muscle group activation patterns and their relationship with shoulder and elbow kinematics and kinetics during the overhead throwing motion of softball position players. Eighteen Division I National Collegiate Athletic Association softball players (19.2 ± 1.0 years; 68.9 ± 8.7 kg; 168.6 ± 6.6 cm) who were listed on the active playing roster volunteered. Electromyographic, kinematic, and kinetic data were collected while players caught a simulated hit or pitched ball and perform their position throw. Pearson correlation revealed a significant negative correlation between non-throwing gluteus maximus during the phase of maximum external rotation to maximum internal rotation (MIR) and elbow moments at ball release (r = -0.52). While at ball release, trunk flexion and rotation both had a positive relationship with shoulder moments at MIR (r = 0.69, r = 0.82, respectively) suggesting that the kinematic actions of the pelvis and trunk are strongly related to the actions of the shoulder during throwing.

  8. The role of ultrasonography in the diagnosis of gluteal muscle contracture.

    Science.gov (United States)

    Li, Qiu; Lingyan, Zhang; Yan, Luo; Yulan, Peng

    2011-02-01

    To evaluate the use of ultrasonography (US) in the diagnosis of gluteal muscle contracture (GMC) by analysis of its imaging characteristics. Thirty-nine patients suspected of having GMC due to abnormal gait underwent pre-operative US. The diagnosis of GMC was confirmed by surgery in 27 patients. Six patients were diagnosed with congenital hip dysplasia, and the remaining six patients were diagnosed with sciatic nerve damage, post-poliomyelitis sequelae, and myasthenia gravis. For the patients with GMC, US showed muscle thinning and hyperechoic strips (specific for muscular contracture) in the muscles involved. In three patients with GMC, the strips were integrated into muscle bundles, demonstrating both strong and weak sonographic echoes. The sensitivity and specificity of the diagnosis of GMC using the presence of strips were 88.9% and 83.3%, respectively, and using muscle thinning, the sensitivity and specificity were 92.6% and 50%, respectively. The contracture strips, as measured by US, were significantly smaller than the actual measurements at the time of surgery, but there was a significant correlation between the two measurements (r = 0.814, P muscle (91.8%), and the lowest rate was found in the piriformis muscle (52.9%). Ultrasonography is a valuable tool for the diagnosis of GMC, especially for the detection of specific contracture strips in involved muscles. Its role in the pre-operative diagnosis of GMC also provides surgical planning that can guide subsequent treatment.

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

    Science.gov (United States)

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

    2014-12-01

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

  10. Alcohol, indomethacin, and salbutamol. A comparative trial of their use in preterm labor.

    Science.gov (United States)

    Spearing, G

    1979-02-01

    In a comparative trial, ethanol effectively arrested preterm labor for 48 hours for more in 32% of cases, a beta-adrenergic agent (salbutamol) in 60% of cases (not statistically significant), and a combination of ethanol and indomethacin in 70% of cases (statistically significant, P less than 0.5). Labor was delayed for 14 days or more in 36, 60, and 50%, respectively (not statistically significant). The numbers studied were small, and tests of statistical significance were of doubtful value. Salbutamol was more acceptable to patients and the staff than ethanol. The trial was suspended and eventually abandoned due to reports of prostaglandin synthetase inhibitors causing premature closure of the ductus arteriosus. In this series no problems were encountered with the use of indomethacin.

  11. Comparing Amazon Mechanical Turk with unpaid internet resources in online clinical trials

    Directory of Open Access Journals (Sweden)

    Eduardo Bunge

    2018-06-01

    Full Text Available Internet interventions face significant challenges in recruitment and attrition rates are typically high and problematic. Finding innovative yet scientifically valid avenues for attaining and retaining participants is therefore of considerable importance. The main goal of this study was to compare recruitment process and participants characteristics between two similar randomized control trials of mood management interventions. One of the trials (Bunge et al., 2016 was conducted with participants recruited from Amazon's Mechanical Turk (AMT, and the other trial recruited via Unpaid Internet Resources (UIR. Methods: The AMT sample (Bunge et al., 2016 consisted of 765 adults, and the UIR sample (recruited specifically for this study consisted of 329 adult US residents. Participants' levels of depression, anxiety, confidence, motivation, and perceived usefulness of the intervention were assessed. The AMT sample was financially compensated whereas the UIR was not. Results: AMT yielded higher recruitment rates per month (p < .05. At baseline, the AMT sample reported significantly lower depression and anxiety scores (p < .001 and p < .005, respectively and significantly higher mood, motivation, and confidence (all p < .001 compared to the UIR sample. AMT participants spent significantly less time on the site (p < .05 and were more likely to complete follow-ups than the UIR sample (p < .05. Both samples reported a significant increase in their level of confidence and motivation from pre- to post-intervention. AMT participants showed a significant increase in perceived usefulness of the intervention (p < .0001, whereas the UIR sample did not (p = .1642. Conclusions: By using AMT, researchers can recruit very rapidly and obtain higher retention rates; however, these participants may not be representative of the general online population interested in clinical interventions. Considering that AMT and UIR participants

  12. Assessment of fatty degeneration of the gluteal muscles in patients with THA using MRI: reliability and accuracy of the Goutallier and quartile classification systems.

    Science.gov (United States)

    Engelken, Florian; Wassilew, Georgi I; Köhlitz, Torsten; Brockhaus, Sebastian; Hamm, Bernd; Perka, Carsten; Diederichs, und Gerd

    2014-01-01

    The purpose of this study was to quantify the performance of the Goutallier classification for assessing fatty degeneration of the gluteus muscles from magnetic resonance (MR) images and to compare its performance to a newly proposed system. Eighty-four hips with clinical signs of gluteal insufficiency and 50 hips from asymptomatic controls were analyzed using a standard classification system (Goutallier) and a new scoring system (Quartile). Interobserver reliability and intraobserver repeatability were determined, and accuracy was assessed by comparing readers' scores with quantitative estimates of the proportion of intramuscular fat based on MR signal intensities (gold standard). The existing Goutallier classification system and the new Quartile system performed equally well in assessing fatty degeneration of the gluteus muscles, both showing excellent levels of interrater and intrarater agreement. While the Goutallier classification system has the advantage of being widely known, the benefit of the Quartile system is that it is based on more clearly defined grades of fatty degeneration. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

    Science.gov (United States)

    Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

    2013-01-01

    Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

  14. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

    Directory of Open Access Journals (Sweden)

    Jessica L. Thomson

    2016-01-01

    Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

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

    Directory of Open Access Journals (Sweden)

    Mohammad Dehghani Firoozabadi

    2014-01-01

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

  16. A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

    Science.gov (United States)

    Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

    2017-02-01

    To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

  17. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  18. Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

    Science.gov (United States)

    van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

    2018-01-01

    had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

  19. DIFFERENTIAL DIAGNOSIS OF DEEP GLUTEAL PAIN IN A FEMALE RUNNER WITH PELVIC INVOLVEMENT: A CASE REPORT

    Science.gov (United States)

    Podschun, Laura; Kolber, Morey J.; Garcia, Ashley; Rothschild, Carey E.

    2013-01-01

    Background: Gluteal injuries, proximal hamstring injuries, and pelvic floor disorders have been reported in the literature among runners. Some suggest that hip, pelvis, and/or groin injuries occur in 3.3% to 11.5% of long distance runners. The purpose of this case report is to describe the differential diagnosis and treatment approach for a patient presenting with combined hip and pelvic pain. Case description: A 45-year-old female distance runner was referred to physical therapy for proximal hamstring pain that had been present for several months. This pain limited her ability to tolerate sitting and caused her to cease running. Examination of the patient's lumbar spine, pelvis, and lower extremity led to the initial differential diagnosis of hamstring syndrome and ischiogluteal bursitis. The patient's primary symptoms improved during the initial four visits, which focused on education, pain management, trunk stabilization and gluteus maximus strengthening, however pelvic pain persisted. Further examination led to a secondary diagnosis of pelvic floor hypertonic disorder. Interventions to address the pelvic floor led to resolution of symptoms and return to running. Outcomes: Pain level on the Visual Analog Scale decreased from 7/10 to 1/10 over the course of treatment. The patient was able to return to full sport activity and improved sitting tolerance to greater then two hours without significant discomfort. Discussion: This case suggests the interdependence of lumbopelvic and lower extremity kinematics in complaints of hamstring, posterior thigh and pelvic floor disorders. This case highlights the importance of a thorough examination as well as the need to consider a regional interdependence of the pelvic floor and lower quarter when treating individuals with proximal hamstring pain. Level of Evidence: Level 4 PMID:24175132

  20. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Science.gov (United States)

    Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

    2010-06-08

    Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Would guidance from a technician be as effective as guidance from a clinician? Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (ptechnician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services. Australian New

  1. Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

    Science.gov (United States)

    Molt, Mats; Toksvig-Larsen, Sören

    2014-10-01

    The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. The effects of Red Bull energy drink compared with caffeine on cycling time-trial performance.

    Science.gov (United States)

    Quinlivan, Alannah; Irwin, Christopher; Grant, Gary D; Anoopkumar-Dukie, Sheilandra; Skinner, Tina; Leveritt, Michael; Desbrow, Ben

    2015-10-01

    This study investigated the ergogenic effects of a commercial energy drink (Red Bull) or an equivalent dose of anhydrous caffeine in comparison with a noncaffeinated control beverage on cycling performance. Eleven trained male cyclists (31.7 ± 5.9 y 82.3 ± 6.1 kg, VO2max = 60.3 ± 7.8 mL · kg-1 · min-1) participated in a double-blind, placebo-controlled, crossover-design study involving 3 experimental conditions. Participants were randomly administered Red Bull (9.4 mL/kg body mass [BM] containing 3 mg/kg BM caffeine), anhydrous caffeine (3 mg/kg BM given in capsule form), or a placebo 90 min before commencing a time trial equivalent to 1 h cycling at 75% peak power output. Carbohydrate and fluid volumes were matched across all trials. Performance improved by 109 ± 153 s (2.8%, P = .039) after Red Bull compared with placebo and by 120 ± 172 s (3.1%, P = .043) after caffeine compared with placebo. No significant difference (P > .05) in performance time was detected between Red Bull and caffeine treatments. There was no significant difference (P > .05) in mean heart rate or rating of perceived exertion among the 3 treatments. This study demonstrated that a moderate dose of caffeine consumed as either Red Bull or in anhydrous form enhanced cycling time-trial performance. The ergogenic benefits of Red Bull energy drink are therefore most likely due to the effects of caffeine, with the other ingredients not likely to offer additional benefit.

  3. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    Directory of Open Access Journals (Sweden)

    van Eijk RPA

    2018-03-01

    Full Text Available Ruben PA van Eijk,1 Marinus JC Eijkemans,2 Dimitris Rizopoulos,3 Leonard H van den Berg,4,* Stavros Nikolakopoulos5,* 1Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands; 3Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands; 4Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands *These authors contributed equally to this work Objective: Amyotrophic lateral sclerosis (ALS clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1 Cox model; 2 linear mixed effects (LME model; 3 omnibus test based on Cox and LME models; 4 composite time-to-6-point decrease or death; 5 combined assessment of function and survival (CAFS; and 6 test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results: Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point

  4. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krogh, Thøger Persson; Bartels, Else Marie; Ellingsen, Torkell; Stengaard-Pedersen, Kristian; Buchbinder, Rachelle; Fredberg, Ulrich; Bliddal, Henning; Christensen, Robin

    2013-06-01

    Injection therapy with glucocorticoids has been used since the 1950s as a treatment strategy for lateral epicondylitis (tennis elbow). Lately, several novel injection therapies have become available. To assess the comparative effectiveness and safety of injection therapies in patients with lateral epicondylitis. Systematic review and meta-analysis. Randomized controlled trials comparing different injection therapies for lateral epicondylitis were included provided they contained data for change in pain intensity (primary outcome). Trials were assessed using the Cochrane risk of bias tool. Network (random effects) meta-analysis was applied to combine direct and indirect evidence within and across trial data using the final end point reported in the trials, and results for the arm-based network analyses are reported as standardized mean differences (SMDs). Seventeen trials (1381 participants; 3 [18%] at low risk of bias) assessing injection with 8 different treatments-glucocorticoid (10 trials), botulinum toxin (4 trials), autologous blood (3 trials), platelet-rich plasma (2 trials), and polidocanol, glycosaminoglycan, prolotherapy, and hyaluronic acid (1 trial each)-were included. Pooled results (SMD [95% confidence interval]) showed that beyond 8 weeks, glucocorticoid injection was no more effective than placebo (-0.04 [-0.45 to 0.35]), but only 1 trial (which did not include a placebo arm) was at low risk of bias. Although botulinum toxin showed marginal benefit (-0.50 [-0.91 to -0.08]), it caused temporary paresis of finger extension, and all trials were at high risk of bias. Both autologous blood (-1.43 [-2.15 to -0.71]) and platelet-rich plasma (-1.13 [-1.77 to -0.49]) were also statistically superior to placebo, but only 1 trial was at low risk of bias. Prolotherapy (-2.71 [-4.60 to -0.82]) and hyaluronic acid (-5.58 [-6.35 to -4.82]) were both more efficacious than placebo, whereas polidocanol (0.39 [-0.42 to 1.20]) and glycosaminoglycan (-0.32 [-1.02 to 0

  5. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Geladé, Katleen; Janssen, Tieme W. P.; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-01-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally

  6. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Gelade, K.; Janssen, T.W.P.; Bink, M.; van Mourik, R.; Maras, A.; Oosterlaan, J.

    2016-01-01

    Objective: The efficacy of neurofeedback as treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, are still intensely debated subjects. The current randomised controlled trial compared neurofeedback to (1) optimally

  7. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

    Directory of Open Access Journals (Sweden)

    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  8. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

    Science.gov (United States)

    Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-01-01

    Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with

  9. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

    Science.gov (United States)

    Howard, Courtney; Rose, Caren Lee; Trouton, Konia; Stamm, Holly; Marentette, Danielle; Kirkpatrick, Nicole; Karalic, Sanja; Fernandez, Renee; Paget, Julie

    2011-06-01

    To determine whether menstrual cups are a viable alternative to tampons. Randomized controlled trial. Prince George, Victoria, and Vancouver, BC. A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

  10. Dextrose saline compared with normal saline rehydration of hyperemesis gravidarum: a randomized controlled trial.

    Science.gov (United States)

    Tan, Peng Chiong; Norazilah, Mat Jin; Omar, Siti Zawiah

    2013-02-01

    To compare 5% dextrose-0.9% saline against 0.9% saline solution in the intravenous rehydration of hyperemesis gravidarum. Women at their first hospitalization for hyperemesis gravidarum were enrolled on admission to the ward and randomly assigned to receive either 5% dextrose-0.9% saline or 0.9% saline by intravenous infusion at a rate 125 mL/h over 24 hours in a double-blind trial. All participants also received thiamine and an antiemetic intravenously. Oral intake was allowed as tolerated. Primary outcomes were resolution of ketonuria and well-being (by 10-point visual numerical rating scale) at 24 hours. Nausea visual numerical rating scale scores were obtained every 8 hours for 24 hours. Persistent ketonuria rates after the 24-hour study period were 10 of 101 (9.9%) compared with 11 of 101 (10.9%) (P>.99; relative risk 0.9, 95% confidence interval 0.4-2.2) and median (interquartile range) well-being scores at 24 hours were 9 (8-10) compared with 9 (8-9.5) (P=.73) in the 5% dextrose-0.9% saline and 0.9% saline arms, respectively. Repeated measures analysis of variance of the nausea visual numerical rating scale score as assessed every 8 hours during the 24-hour study period showed a significant difference in favor of the 5% dextrose-0.9% saline arm (P=.046) with the superiority apparent at 8 and 16 hours, but the advantage had dissipated by 24 hours. Secondary outcomes of vomiting, resolution of hyponatremia, hypochloremia and hypokalemia, length of hospitalization, duration of intravenous antiemetic, and rehydration were not different. Intravenous rehydration with 5% dextrose-0.9% saline or 0.9% saline solution in women hospitalized for hyperemesis gravidarum produced similar outcomes. ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN65014409. I.

  11. Cellulite and extracorporeal Shockwave therapy (CelluShock-2009 - a Randomized Trial

    Directory of Open Access Journals (Sweden)

    Joest Beatrice

    2010-10-01

    Full Text Available Abstract Background Cellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite. Methods/Design Study design: Randomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet. Analysis: Intention-to-treat. Outcome parameters: a Photonumeric severity scale, b Nürnberger Score, c circumference measurements, d capillary blood flow, e tissue oxygen saturation, f postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks at both gluteal and thigh regions plus a specific gluteal strength exercise training. Control group: Six sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks at both gluteal and thigh regions plus a specific gluteal

  12. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  13. A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

    Science.gov (United States)

    Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

    2009-01-01

    Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

  14. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    Science.gov (United States)

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (pcomputer vision syndrome.

  15. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  16. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

  17. Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy.

    Science.gov (United States)

    Moonen, A; Busch, O; Costantini, M; Finotti, E; Tack, J; Salvador, R; Boeckxstaens, G; Zaninotto, G

    2017-11-01

    A recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present study was to perform an economic analysis of the European achalasia trial. Patients with newly diagnosed achalasia were enrolled from to 2003 to 2008 in 14 centers in five European countries and were randomly assigned to either pneumatic dilation (PD) or laparoscopic Heller (LHM). The economic analysis was performed in the three centers in three different countries where most patients were enrolled (Amsterdam [NL], Leuven, [B] and Padova [I]) and then applied to all patients included in the study. The total raw costs of the two treatments per patient include the initial costs, the costs of complications, and the costs of retreatments. Two hundred and one patients, 107 (57 males and 50 females, mean age 46 CI: 43-49 years) were randomized to LHM and 94 (59 males and 34 females, mean age 46 CI 43-50 years) to PD. The total cost of PD per patient was quite comparable in the three different centers; €3397 in Padova, €3259 in Amsterdam and €3792 in Leuven. For LHM, the total costs per patient were highest in Amsterdam: €4488 in Padova, €6720 in Amsterdam, and €5856 in Leuven. In conclusion, the strategy of treating achalasia starting with PD appears the most economic approach, independent of the health system. © 2017 John Wiley & Sons Ltd.

  18. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  19. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    Science.gov (United States)

    Robinson, Emma; Titov, Nickolai; Andrews, Gavin; McIntyre, Karen; Schwencke, Genevieve; Solley, Karen

    2010-06-03

    Internet-based cognitive behavioural therapy (iCBT) for generalized anxiety disorder (GAD) has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ) and the Generalized Anxiety Disorder-7 Item (GAD-7). Completion rates were high, and both treatment groups reduced scores on the PSWQ (ptechnician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment/control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for GAD. This form of treatment has potential to increase the

  20. Gluteal blood flow and oxygenation during electrical stimulation-induced muscle activation versus pressure relief movements in wheelchair users with a spinal cord injury

    NARCIS (Netherlands)

    Smit, C. A. J.; Zwinkels, M.; van Dijk, T.; de Groot, S.; Stolwijk-Swuste, J. M.; Janssen, T. W. J.

    Background: Prolonged high ischial tuberosities pressure (IT pressure), decreased regional blood flow (BF) and oxygenation (%SO2) are risk factors for developing pressure ulcers (PUs) in patients with spinal cord injury (SCI). Electrical stimulation (ES)-induced gluteal and hamstring muscle

  1. The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial.

    Science.gov (United States)

    Walsh, Michael; Manns, Braden J; Klarenbach, Scott; Tonelli, Marcello; Hemmelgarn, Brenda; Culleton, Bruce

    2010-04-01

    Hyperphosphatemia is common among patients receiving dialysis and is associated with increased mortality. Nocturnal hemodialysis (NHD) is a long, slow dialytic modality that may improve hyperphosphatemia and disorders of mineral metabolism. We performed a randomized-controlled trial of NHD compared with conventional hemodialysis (CvHD); in this paper, we report detailed results of mineral metabolism outcomes. Prevalent patients were randomized to receive NHD 5 to 6 nights per week for 6to 10 hours per night or to continue CvHD thrice weekly for 6 months. Oral phosphate binders and vitamin D analogs were adjusted to maintain phosphate, calcium and parathyroid hormone (PTH) levels within recommended targets. Compared with CvHD patients, patients in the NHD group had a significant decrease in serum phosphate over the course of the study (0.49 mmol/L, 95% confidence interval 0.24-0.74; P=0.002) despite a significant reduction in the use of phosphate binders. Sixty-one percent of patients in the NHD group compared with 20% in the CvHD group had a decline in intact PTH (P=0.003). Nocturnal hemodialysis lowers serum phosphate, calcium-phosphate product and requirement for phosphate binders. The effects of NHD on PTH are variable. The impact of these changes on long-term cardiovascular and bone-related outcomes requires further investigation.

  2. Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2009-08-01

    Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

  3. A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

    Science.gov (United States)

    Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

    2015-05-01

    The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  4. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  5. Comparative costs and activity from a sample of UK clinical trials units.

    Science.gov (United States)

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  6. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    ). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

  7. Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.

    Science.gov (United States)

    Culligan, Patrick J; Salamon, Charbel; Priestley, Jennifer L; Shariati, Amir

    2013-01-01

    To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh. Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months (α=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered "clinical failures"; the rest were "clinical cures." Statistical comparisons were performed using the χ or independent samples t test as appropriate. As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the "clinical cure" rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications. There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. I.

  8. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

    Science.gov (United States)

    Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

    2015-06-01

    Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  9. Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

    Science.gov (United States)

    James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

    2016-08-01

    Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

    Science.gov (United States)

    Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

    2016-04-06

    To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

  11. A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

    Science.gov (United States)

    Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

    2018-01-01

    This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

  12. Comparing the effects of Calendula officinalis and clotrimazole on vaginal Candidiasis: A randomized controlled trial.

    Science.gov (United States)

    Saffari, Elnaz; Mohammad-Alizadeh-Charandabi, Sakineh; Adibpour, Mohammad; Mirghafourvand, Mojgan; Javadzadeh, Yousef

    2017-01-01

    This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18-45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10-15 and 30-35 days after intervention and the female sexual function index was assessed at 30-35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16-0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5-6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.

  13. Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

    Science.gov (United States)

    Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

    2012-12-01

    To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  14. Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

    Science.gov (United States)

    Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare

    2017-10-01

    Biological treatments such as adalimumab (Humira ® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t -test and 80% retention

  15. Estrogen receptor protein content is different in abdominal than gluteal subcutaneous adipose tissue of overweight-to-obese premenopausal women.

    Science.gov (United States)

    Gavin, Kathleen M; Cooper, Elizabeth E; Hickner, Robert C

    2013-08-01

    Premenopausal women demonstrate a distinctive gynoid body fat distribution and circulating estrogen status is associated with the maintenance of this adiposity patterning. Estrogen's role in modulation of regional adiposity may occur through estrogen receptors (ERs), which are present in human adipose tissue. The purpose of this study was to determine regional differences in the protein content of ERα, ERβ, and the G protein-coupled estrogen receptor (GPER) between the abdominal (AB) and gluteal (GL) subcutaneous adipose tissue of overweight-to-obese premenopausal women. Biopsies of the subcutaneous AB and GL adipose tissue were performed in 15 premenopausal women (7 Caucasian/8 African American, 25.1 ± 1.8 years, BMI 29.5 ± 0.5kg/m(2)). Adipose tissue protein content was measured by western blot analysis and correlation analyses were conducted to assess the relationship between ER protein content and anthropometric indices/body composition measurements. We found that ERα protein was higher in AB than GL (AB 1.0 ± 0.2 vs GL 0.67 ± 0.1 arbitrary units [AU], P=0.02), ERβ protein was higher in GL than AB (AB 0.78 ± 0.12 vs GL 1.3 ± 0.2 AU, P=0.002), ERα/ERβ ratio was higher in AB than GL (AB 1.9 ± 0.4 vs GL 0.58 ± 0.08 AU, P=0.007), and GPER protein content was similar in AB and GL (P=0.80) subcutaneous adipose tissue. Waist-to-hip ratio was inversely related to gluteal ERβ (r(2)=0.315, P=0.03) and positively related to gluteal ERα/ERβ ratio (r(2)=0.406, P=0.01). These results indicate that depot specific ER content may be an important underlying determinant of regional effects of estrogen in upper and lower body adipose tissue of overweight-to-obese premenopausal women. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. Risk factors for low vision related functioning in the Mycotic Ulcer Treatment Trial: a randomised trial comparing natamycin with voriconazole.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; Porco, Travis C; McLeod, Stephen D; Acharya, Nisha R; Keenan, Jeremy D; Lietman, Thomas M

    2016-07-01

    The Mycotic Ulcer Treatment Trial I (MUTT I) was a double-masked, multicentre, randomised controlled trial, which found that topical natamycin is superior to voriconazole for the treatment of filamentous fungal corneal ulcers. In this study, we determine risk factors for low vision-related quality of life in patients with fungal keratitis. The Indian visual function questionnaire (IND-VFQ) was administered to MUTT I study participants at 3 months. Associations between patient and ulcer characteristics and IND-VFQ subscale score were assessed using generalised estimating equations. 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. Out of a total possible score of 100, the average VFQ score for all participants was 81.3 (range 0-100, SD 23.6). After correcting for treatment arm, each logMAR line of worse baseline visual acuity in the affected eye resulted in an average 1.2 points decrease on VFQ at 3 months (95% CI -1.8 to 0.6, p<0.001). Those who required therapeutic penetrating keratoplasty had an average of 25.2 points decrease on VFQ after correcting for treatment arm (95% CI -31.8 to -18.5, p<0.001). Study participants who were unemployed had on average 28.5 points decrease on VFQ (95% CI -46.9 to -10.2, p=0.002) after correcting for treatment arm. Monocular vision loss from corneal opacity due to fungal keratitis reduced vision-related quality of life. Given the relatively high worldwide burden of corneal opacity, improving treatment outcomes of corneal infections should be a public health priority. Clinicaltrials.gov Identifier: NCT00996736. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

    Science.gov (United States)

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

    2016-04-01

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

  18. Elastofibroma of the gluteal region with a concomitant contralateral lesion: case report and review of the literature

    Energy Technology Data Exchange (ETDEWEB)

    Cevolani, Luca; Casadei, R.; Donati, D. [Rizzoli Orthopaedic Institute, III Orthopaedic and Traumatology Clinic, Bologna (Italy); Vanel, D.; Gambarotti, M. [Rizzoli Orthopaedic Institute, Bone Tumor Center, Bologna (Italy)

    2017-03-15

    A 51-year-old man presented with elastofibroma (EF) of the gluteal region with a concomitant contralateral lesion. The patient presented with a slow growing mass of the proximal third of the right buttock and had swelling, discomfort in sitting, and right-hip pain during walking for 2 months. On MRI, a soft-tissue mass was noted between the gluteus maximus and the gluteus medius muscle. The mass showed similar signal intensity to the surrounding tissue on T1- and T2-weighted images and with linear hyperintense areas in its internal structure. At surgery, a soft, non-encapsulated, irregular, and rubber-like mass was found attached to the gluteus medius muscles. It was pathologically confirmed to be an EF. This unusual manifestation of an EF is discussed. (orig.)

  19. Coexpression network analysis in abdominal and gluteal adipose tissue reveals regulatory genetic loci for metabolic syndrome and related phenotypes

    DEFF Research Database (Denmark)

    Min, Josine L; Nicholson, George; Halgrimsdottir, Ingileif

    2012-01-01

    Metabolic Syndrome (MetS) is highly prevalent and has considerable public health impact, but its underlying genetic factors remain elusive. To identify gene networks involved in MetS, we conducted whole-genome expression and genotype profiling on abdominal (ABD) and gluteal (GLU) adipose tissue...... and 51 (0.6%) in GLU only. Differential eigengene network analysis of 8,256 shared probesets detected 22 shared modules with high preservation across adipose depots (D(ABD-GLU) = 0.89), seven of which were associated with MetS (FDR P100,000 individuals; rs10282458, affecting expression of RARRES2...... and their interactions influence complex traits such as MetS, integrated analysis of genotypes and coexpression networks across multiple tissues relevant to clinical traits is an efficient strategy to identify novel associations....

  20. Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects.

    Science.gov (United States)

    Alexander, D. A.; Naji, A. A.; Pinion, S. B.; Mollison, J.; Kitchener, H. C.; Parkin, D. E.; Abramovich, D. R.; Russell, I. T.

    1996-01-01

    OBJECTIVE: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. DESIGN: Prospective randomised controlled trial. SETTING--Obstetrics and gynaecology department of a large teaching hospital. SUBJECTS: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women). MAIN OUTCOME MEASURES: Mental state, martial relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. RESULTS: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. CONCLUSIONS: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. PMID:8611783

  1. Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation.

    Science.gov (United States)

    Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E

    2014-03-01

    Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (ptext messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.

  2. Troxipide in the Management of Gastritis: A Randomized Comparative Trial in General Practice

    Directory of Open Access Journals (Sweden)

    Bhupesh Dewan

    2010-01-01

    Full Text Available Background. A trial of empirical acid-suppressive therapy is the usual practice for most patients with symptoms of gastritis in primary care. Aim. To assess the relative efficacy of Troxipide and Ranitidine in patients with endoscopic gastritis over a four-week period. Methods. In all, 142 patients were randomized to Troxipide (100 mg tid or Ranitidine (150 mg bid for a period of four weeks. The severity of the signs of endoscopic gastritis at baseline and week 4 using a four-point scale and the subjective symptom severity at baseline and week 2 & week 4 using a Visual analog scale (VAS were documented. Results. Troxipide was found to be superior to Ranitidine for both, the complete resolution and improvement of endoscopic gastritis. Higher proportion of patients showed complete healing of erosions (88.14%, oozing (96.77%, and edema (93.88% with Troxipide as compared to Ranitidine (<.01. Patients receiving Troxipide also showed a greater improvement in the VAS scores for abdominal pain, bloating, and heartburn (<.01. Both the drugs were found to be well tolerated. Conclusion. In patients with endoscopic gastritis, Troxipide, with its superior rate of improvement, resolution of signs, and subjective clinical symptoms, can be considered as an alternative to the commonly used antisecretory agents.

  3. Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

    Science.gov (United States)

    Williams, N S; Johnston, D

    1980-07-12

    Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe.

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

    Science.gov (United States)

    Shepherd, Jonathan P

    2003-06-01

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

  5. A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

    Science.gov (United States)

    Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

    2017-09-01

    Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p advance directive to be a better alternative to the traditional advance directive form.

  6. Anatomical basis of the lateral superior gluteal artery perforator (LSGAP) flap and role in bilateral breast reconstruction.

    Science.gov (United States)

    Fade, Geraldine; Gobel, Fabienne; Pele, Eric; Chaput, Benoit; Garrido, Ignacio; Pinsolle, Vincent; Pelissier, Philippe; Sinna, Raphael

    2013-06-01

    Deep inferior epigastric perforator (DIEP) flap is one of the gold standards in autologous breast reconstruction. When the abdominal tissue is not available, the superior gluteal artery perforator (SGAP) is often a second option with its drawback, especially the donor-site deformity. Reports have highlighted that a higher and more lateral SGAP flap can be harvested to overcome several drawbacks of the classical SGAP, allowing in the same procedure a body-contouring procedure. In order to set the anatomical basis of this flap, we proposed to study the characteristics of a reliable and easily identifiable superior and lateral perforator of the superior gluteal artery (lateral SGAP (LSGAP)) situated in the region of the lower body-lift resection allowing to perform bilateral breast reconstruction at the same time. The anatomical study of 50 scans (or 100 buttocks) allows us to set forth a diagnostic assumption on the localisation of the perforator with respect to osseous landmarks (coccyx, iliac crest and great trochanter) which will be verified during the dissection of 10 cadavers (or 20 buttocks) and during the 20 colour Doppler examination (or 40 buttocks). In our computed tomography (CT) scan study, in 96% of cases, the perforator was situated in a circle with a radius≤3 cm with a 95% confidence interval and located at the junction of the proximal third-middle third of the distance summit of the posterior iliac crest (point B), most lateral point of the greater trochanter (point C). This assumption was verified by the cadaveric dissection and in vivo studies. Our study sets the anatomical landmarks of the LSGAP flap. This option allows the raising of an SGAP flap avoiding the main drawbacks of this flap and allows harvesting a flap with the tissue that is often discarded during the body-lift procedure. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  7. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

    Science.gov (United States)

    Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-03-21

    To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group

  8. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Anderson, James W; Weiter, Kathy M; Christian, Amber L; Ritchey, Michelle B; Bays, Harold E

    2014-01-01

    To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors. A 12-week, randomized, controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors. Men and women were randomized to snacks (n = 15) or raisins (n = 31). Outcome measures were performed at baseline, 4, 8, and 12 weeks. Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks. Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks; changes with raisin intake were -13.1 mg/dL (P = 0.003 vs baseline; P = 0.03 vs snacks). Eating raisins significantly decreased glycated hemoglobin (HbA1c) level (-0.12%; P = 0.004), a significantly greater level decrease than seen with snack intake (P = 0.036). Snack intake did not significantly affect subject systolic or diastolic blood pressure (BP). Raisin intake was associated with reductions in systolic blood pressure (SBP) at 4, 8, and 12 weeks with mean changes of -6.0 to 10.2 mmHg; all these changes were statistically significant (P = 0.015 to 0.001). Raisins were associated with significantly greater changes in diastolic blood pressure (DBP) at 4, 8, and 12 weeks than snacks (P < 0.05). Body weight did not significantly change within or between groups. Regular consumption of raisins may reduce glycemia and cardiovascular risk factors, including BP rate.

  9. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

    Science.gov (United States)

    Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

    2017-11-01

    To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  10. Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.

    Science.gov (United States)

    Kavitt, R T; Ates, F; Slaughter, J C; Higginbotham, T; Shepherd, B D; Sumner, E L; Vaezi, M F

    2016-11-01

    The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy. © 2015 International Society for Diseases of the Esophagus.

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

    Science.gov (United States)

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

    2013-11-07

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

  12. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

    Science.gov (United States)

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2011-03-01

    Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

  13. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  14. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  15. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    NARCIS (Netherlands)

    Pagnoux, C.; Carette, S.; Khalidi, N. A.; Walsh, M.; Hiemstra, T. F.; Cuthbertson, D.; Langford, C.; Hoffman, G.; Koening, C. L.; Monach, P. A.; Moreland, L.; Mouthon, L.; Seo, P.; Specks, U.; Ytterbere, S.; Westman, K.; Hoglund, P.; Harper, L.; Flossmann, O.; Luqmani, R.; Savage, C.; Rasmussen, N.; de Groot, K.; Tesar, V.; Jayne, D.; Merkel, P. A.; Guillevin, L.; Stegeman, C. A.

    2015-01-01

    Objective. To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods. The main characteristics and outcomes of patients with

  16. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations

    NARCIS (Netherlands)

    K-M. Beeh (Kai-Michael); B. Hederer (Bettina); T. Glaab (Thomas); A. Müller (Achim); M.P.M.H. Rutten-van Mölken (Maureen); S. Kesten (Steven); C. Vogelmeier (Claus)

    2009-01-01

    textabstractAbstract Currently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary

  17. A randomized trial comparing didactics, demonstration, and simulation for teaching teamwork to medical residents.

    Science.gov (United States)

    Semler, Matthew W; Keriwala, Raj D; Clune, Jennifer K; Rice, Todd W; Pugh, Meredith E; Wheeler, Arthur P; Miller, Alison N; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A

    2015-04-01

    Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" score. Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs(2)] = 0.267, P teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.

  18. A Randomized Trial Comparing Didactics, Demonstration, and Simulation for Teaching Teamwork to Medical Residents

    Science.gov (United States)

    Keriwala, Raj D.; Clune, Jennifer K.; Rice, Todd W.; Pugh, Meredith E.; Wheeler, Arthur P.; Miller, Alison N.; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A.

    2015-01-01

    Rationale: Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. Objectives: In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. Methods: This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel “Recognize, Respond, Reassess” score. Measurements and Main Results: Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs2] = 0.267, P didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities. PMID:25730661

  19. Contura Multi-Lumen Balloon Breast Brachytherapy Catheter: Comparative Dosimetric Findings of a Phase 4 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arthur, Douglas W., E-mail: darthur@mcvh-vcu.edu [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Vicini, Frank A. [Michigan Healthcare Professionals/21st Century Oncology, Farmington Hills, Michigan (United States); Todor, Dorin A. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Julian, Thomas B. [Allegheny General Hospital, Temple University School of Medicine, Pittsburgh, Pennsylvania (United States); Cuttino, Laurie W.; Mukhopadhyay, Nitai D. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States)

    2013-06-01

    Purpose: Final dosimetric findings of a completed, multi-institutional phase 4 registry trial using the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer are presented. Methods and Materials: Three dosimetric plans with identical target coverage were generated for each patient for comparison: multilumen multidwell (MLMD); central-lumen multidwell (CLMD); and central-lumen single-dwell (CLSD) loading of the Contura catheter. For this study, a successful treatment plan achieved ideal dosimetric goals and included the following: ≥95% of the prescribed dose (PD) covering ≥95% of the target volume (TV); maximum skin dose ≤125% of the PD; maximum rib dose ≤145% of the PD; and V150 ≤50 cc and V200 ≤10 cc. Results: Between January 2008 and February 2011, 23 institutions participated. A total of 318 patients were available for dosimetric review. Using the Contura MLB, all dosimetric criteria were met in 78.93% of cases planned with MLMD versus 55.38% with the CLMD versus 37.66% with the CLSD (P≤.0001). Evaluating all patients with the full range of skin to balloon distance represented, median maximum skin dose was reduced by 12% and median maximum rib dose by 13.9% when using MLMD-based dosimetric plans compared to CLSD. The dosimetric benefit of MLMD was further demonstrated in the subgroup of patients where skin thickness was <5 mm, where MLMD use allowed a 38% reduction in median maximum skin dose over CLSD. For patients with rib distance <5 mm, the median maximum rib dose reduction was 27%. Conclusions: Use of the Contura MLB catheter produced statistically significant improvements in dosimetric capabilities between CLSD and CLMD treatments. This device approach demonstrates the ability not only to overcome the barriers of limited skin thickness and close rib proximity, but to consistently achieve a higher standard of dosimetric planning goals.

  20. Contura Multi-Lumen Balloon breast brachytherapy catheter: comparative dosimetric findings of a phase 4 trial.

    Science.gov (United States)

    Arthur, Douglas W; Vicini, Frank A; Todor, Dorin A; Julian, Thomas B; Cuttino, Laurie W; Mukhopadhyay, Nitai D

    2013-06-01

    Final dosimetric findings of a completed, multi-institutional phase 4 registry trial using the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer are presented. Three dosimetric plans with identical target coverage were generated for each patient for comparison: multilumen multidwell (MLMD); central-lumen multidwell (CLMD); and central-lumen single-dwell (CLSD) loading of the Contura catheter. For this study, a successful treatment plan achieved ideal dosimetric goals and included the following: ≥ 95% of the prescribed dose (PD) covering ≥ 95% of the target volume (TV); maximum skin dose ≤ 125% of the PD; maximum rib dose ≤ 145% of the PD; and V150 ≤50 cc and V200 ≤ 10 cc. Between January 2008 and February 2011, 23 institutions participated. A total of 318 patients were available for dosimetric review. Using the Contura MLB, all dosimetric criteria were met in 78.93% of cases planned with MLMD versus 55.38% with the CLMD versus 37.66% with the CLSD (P ≤.0001). Evaluating all patients with the full range of skin to balloon distance represented, median maximum skin dose was reduced by 12% and median maximum rib dose by 13.9% when using MLMD-based dosimetric plans compared to CLSD. The dosimetric benefit of MLMD was further demonstrated in the subgroup of patients where skin thickness was <5 mm, where MLMD use allowed a 38% reduction in median maximum skin dose over CLSD. For patients with rib distance <5 mm, the median maximum rib dose reduction was 27%. Use of the Contura MLB catheter produced statistically significant improvements in dosimetric capabilities between CLSD and CLMD treatments. This device approach demonstrates the ability not only to overcome the barriers of limited skin thickness and close rib proximity, but to consistently achieve a higher standard of dosimetric planning goals. Copyright © 2013 Elsevier Inc. All rights

  1. Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

    NARCIS (Netherlands)

    Dijkgraaf, Marcel G. W.; van der Zanden, Bart P.; de Borgie, Corianne A. J. M.; Blanken, Peter; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in

  2. Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  3. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  4. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...

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

    Science.gov (United States)

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

    2016-01-01

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

  6. A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome

    NARCIS (Netherlands)

    Adams, E; Vollman, J; Giebner, D; Maurer, M; Dreyer, G; Bailey, L; Anderson, M; Mefford, L; Beaumont, E; Sutton, D; Puppala, B; Mangurten, HH; Secrest, J; Lewis, WJ; Carteaux, P; Bednarek, F; Welsberger, S; Gosselin, R; Pantoja, AF; Belenky, A; Campbell, P; Patole, S; Duenas, M; Kelly, M; Alejo, W; Lewallen, P; DeanLieber, S; Hanft, M; Ferlauto, J; Newell, RW; Bagwell, J; Levine, D; Lipp, RW; Harkavy, K; Vasa, R; Birenbaum, H; Broderick, KA; Santos, AQ; Long, BA; Gulrajani, M; Stern, M; Hopgood, G; Hegyi, T; Alba, J; Christmas, L; McQueen, M; Nichols, N; Brown, M; Quissell, BJ; Rusk, C; Marks, K; Gifford, K; Hoehn, G; Pathak, A; Marino, B; Hunt, P; Fox, [No Value; Sharpstein, C; Feldman, B; Johnson, N; Beecham, J; Balcom, R; Helmuth, W; Boylan, D; Frakes, C; Magoon, M; Reese, K; Schwersenski, J; Schutzman, D; Soll, R; Horbar, JD; Leahy, K; Troyer, W; Juzwicki, C; Anderson, P; Dworsky, M; Reynolds, L; Urrutia, J; Gupta, U; Adray, C

    Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS). Design. Multicenter, randomized trial. Setting. Thirty-eight

  7. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

    Science.gov (United States)

    2011-01-01

    Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

  8. Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial.

    Science.gov (United States)

    Sherman, Scott E; Link, Alissa R; Rogers, Erin S; Krebs, Paul; Ladapo, Joseph A; Shelley, Donna R; Fang, Yixin; Wang, Binhuan; Grossman, Ellie

    2016-10-01

    Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions. A randomized comparative effectiveness trial was conducted. At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months. At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814). Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015. One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40). Intensive counseling was more effective than referral to the

  9. Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

    Science.gov (United States)

    Neuzeret, Pierre-Charles; Morin, Laurent

    2017-11-01

    Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence. To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA). OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest ® , HC407 ® or Philips EasyLife ® ). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses. Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042). This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP. © 2016 ResMed Germany Inc. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.

  10. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  11. Employment and paid work among participants in a randomized controlled trial comparing diacetylmorphine and hydromorphone.

    Science.gov (United States)

    Nikoo, Mohammadali; Vogel, Marc; Choi, Fiona; Song, Michael J; Burghardt, Jensen; Zafari, Zafar; Tabi, Katarina; Frank, Anastasia; Barbic, Skye; Schütz, Christian; Jang, Kerry; Krausz, Michael

    2018-04-12

    Employment is one of the less studied but a significant outcome of medication-assisted treatment. Thus, we aimed to explore employment outcomes of medication-assisted treatment with hydromorphone (HDM) or diacetylmorphine (DAM). The secondary aim was to estimate characteristics of this population as well as treatment-related factors associated with these outcomes. This was a secondary analysis of a randomized, double blind controlled trial. A total of 102 and 100 participants were randomized to receive injectable DAM or HDM for 6 months respectively. In stage 2, 144 participants were randomized again to receive either oral or injectable forms of the medication they received for another 6 months. Participants were interviewed at 5 timepoints: before and 3, 6, 9 and 12 months after treatment assignment. Generalized estimating equations (GEE) with a logit link was fitted to determine factors related to paid work in the past 30 days. Mean age of participants was 44.3 (SD = 9.6) and 59 (29.2%) participants were men. At each timepoint, 6-8 (3.6%-4.1%) participants reported employment in the past 30 days and 40 to 52 (19.7%-26.7%) reported minimum 1 day of paid work. University or college education [OR = 2.12: 95% CI = (1.25, 3.62), P = 0.01] was significantly associated with paid work after adjustment for age, gender, treatment arms, timepoints, days receiving study treatment, physical health, psychological health and crack cocaine use in the past 30 days. The rate of employment was lower among participants of this study compared to similar studies on heroin-assisted treatment. Higher education was associated with increased odds of paid work. A large gap exists between employment rate and the proportion of participants who reported paid work. Supported employment and occupational therapy could optimize the employment outcomes of this population. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. A Randomized Clinical Trial Comparing Methotrexate and Mycophenolate Mofetil for Non-Infectious Uveitis

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne TA; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-01-01

    Objective To compare the relative effectiveness of methotrexate and mycophenolate mofetil for non-infectious intermediate uveitis, posterior uveitis, or panuveitis. Design Multicenter, block-randomized, observer-masked clinical trial Participants Eighty patients with non-infectious intermediate, posterior or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Intervention Patients were randomized to receive 25mg weekly oral methotrexate or 1g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Main Outcome Measures Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤ 10 mg of prednisone and ≤ 2 drops of prednisolone acetate 1% a day and (3) no declaration of treatment failure due to intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Results Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (p=0.09). Treatment failure due to adverse events or tolerability was not significantly different by treatment arm (p=0.99). There were no statistically significant differences between treatment groups in time to corticosteroid-sparing control of inflammation (p=0.44), change in best spectacle-corrected visual acuity (p=0.68), and resolution of macular

  13. A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis.

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne T A; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-10-01

    To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Multicenter, block-randomized, observer-masked clinical trial. Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31). There was no statistically significant difference in corticosteroid-sparing control of

  14. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

    Science.gov (United States)

    Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

    2010-11-01

    The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

  15. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  16. Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

    Directory of Open Access Journals (Sweden)

    Vladimir Grubnik

    2011-06-01

    Full Text Available Introduction: Single-stage laparoscopic procedures for common bile duct (CBD stones are an alternative treatmentoption to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstratedthe feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques.Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD exploration.Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 ±5.8 years (range 27 to 87years. There were two groups of patients. Group I: laparoscopic CBD exploration (138 patients. Group II: open CBD exploration(118 patients. Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA classification;ASA II – 109 patients, ASA III – 59 patients. Bile duct stones were visualized preoperatively by means of US examinationin 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCPin 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography.Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min. The mean duration of openprocedures was 90 min (range 60-150 min. Mean blood loss was much lower in the laparoscopic group than in theopen group (20 ±2 v.s 285 ±27, p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopicgroup and in 15 patients in the open group (p < 0.01. Laparoscopic common bile duct exploration was performedthrough a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach wassuccessful in 76 patients (74.5%. External drainage was used in 25 (32.8% patients with the transcystic approach.Conclusions: Laparoscopic CBD exploration can be performed with

  17. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

    Science.gov (United States)

    Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

    2009-07-01

    The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

  18. 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).

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

    Science.gov (United States)

    Shepherd, Jonathan P.

    2003-01-01

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

  20. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  1. Systematic review and meta-analysis of published, randomized, controlled trials comparing suture anastomosis to stapled anastomosis for ileostomy closure.

    Science.gov (United States)

    Sajid, M S; Craciunas, L; Baig, M K; Sains, P

    2013-12-01

    The objective of this article is to systematically analyze the randomized, controlled trials comparing the effectiveness of suture anastomosis (SUA) versus stapled anastomosis (STA) in patients undergoing ileostomy closure. Randomized, controlled trials comparing the effectiveness of SUA versus STA in patients undergoing ileostomy closure were analyzed using RevMan(®), and combined outcomes were expressed as odds risk ratio (OR) and standardized mean difference (SMD). Four randomized, controlled trials that recruited 645 patients were retrieved from electronic databases. There were 327 patients in the STA group and 318 patients in the SUA group. There was significant heterogeneity among included trials. Operative time (SMD -1.02; 95 % CI -1.89, -0.15; z = 2.29; p infection, reoperation and readmission were similar following STA and SUA in patients undergoing ileostomy closure. Length of hospital stay was also similar between STA and SUA groups. In ileostomy closure, STA was associated with shorter operative time and lower risk of postoperative small bowel obstruction. However, STA and SUA were similar in terms of anastomotic leak, surgical site infection, readmission, reoperations and length of hospital stay.

  2. Reliability of surface electromyography activity of gluteal and hamstring muscles during sub-maximal and maximal voluntary isometric contractions.

    Science.gov (United States)

    Bussey, Melanie D; Aldabe, Daniela; Adhia, Divya; Mani, Ramakrishnan

    2018-04-01

    Normalizing to a reference signal is essential when analysing and comparing electromyography signals across or within individuals. However, studies have shown that MVC testing may not be as reliable in persons with acute and chronic pain. The purpose of this study was to compare the test-retest reliability of the muscle activity in the biceps femoris and gluteus maximus between a novel sub-MVC and standard MVC protocols. This study utilized a single individual repeated measures design with 12 participants performing multiple trials of both the sub-MVC and MVC tasks on two separate days. The participant position in the prone leg raise task was standardised with an ultrasonic sensor to improve task precession between trials/days. Day-to-day and trial-to-trial reliability of the maximal muscle activity was examined using ICC and SEM. Day-to-day and trial-to-trial reliability of the EMG activity in the BF and GM were high (0.70-0.89) to very high (≥0.90) for both test procedures. %SEM was <5-10% for both tests on a given day but higher in the day-to-day comparisons. The lower amplitude of the sub-MVC is a likely contributor to increased %SEM (8-13%) in the day-to-day comparison. The findings show that the sub-MVC modified prone double leg raise results in GM and BF EMG measures similar in reliability and precision to the standard MVC tasks. Therefore, the modified prone double leg raise may be a useful substitute for traditional MVC testing for normalizing EMG signals of the BF and GM. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  4. A randomized controlled trial comparing split and subunit influenza vaccines in adults in Colombia

    Directory of Open Access Journals (Sweden)

    A. Morales

    2003-06-01

    Full Text Available In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripeâ or sub-unit (Agrippal S1â influenza vaccine (1999-2000 formulations. For analysis, study groups were subdivided into adult (18-60 years old and elderly (over 60 years subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well tolerated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripeâ induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% of elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1â. In conclusion, the split-virion and sub-unit influenza vaccines had similar safety and reactogenicity profiles, and elicited satisfactory immunity in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT values in response to the B strain were seen with the split vaccine Imovax Gripeâ, giving it a better overall immunogenicity.En un ensayo comparativo realizado en dos centros, se asignaron de manera aleatoria 344 adultos para recibir una dosis de vacuna contra la gripe de virus fraccionado inactivado (Imovax Gripeâ o de vacuna de subunidades (Agrippal S1â (formulaciones 1999-2000. Para el análisis, los grupos estudiados fueron subdivididos en adultos (18-60 años y ancianos (más de 60 años. La sangre fue extraída justo antes y un mes después de la vacunación. La inocuidad fue evaluada utilizando un informe sobre reacciones adversas, usando un diseño de observador a ciegas. Ambas vacunas fueron muy bien toleradas, con perfiles de reactogenicidad similares y desarrollaron escasas reacciones adversas en los individuos ancianos. La vacunación con

  5. Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

    Science.gov (United States)

    Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

    2013-05-01

    Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

  6. Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

    DEFF Research Database (Denmark)

    Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

    2008-01-01

    Postpartum perineal repair performed by midwives: A randomised trial comparing two suture techniques leaving the skin unsutured. Objective      To compare a continuous suture technique to interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations...... and episiotomies.   Design          A double blind randomised controlled trial.   Setting          A Danish university hospital with more than 4800 deliveries annually.   Population   400 healthy primiparous women with a vaginal delivery at term.   Method         Randomisation was computer-controlled. Structured...... healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 min. vs. 17 min, p=0.03) and less suture material was used (1 vs. 2 packets, pskin unsutured...

  7. Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  8. Treatment of secondary hyperparathyroidism in haemodialysis patients: a randomised clinical trial comparing paricalcitol and alfacalcidol

    DEFF Research Database (Denmark)

    Hansen, Ditte; Brandi, Lisbet; Rasmussen, Knud

    2009-01-01

    BACKGROUND: Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Its serious clinical consequences include renal osteodystrophy, calcific uremic arteriolopathy, and vascular calcifications that increase morbidity and mortality.Reduced synthesis of active vita...... in the risk of cardiovascular mortality depending on which vitamin D analog that are used. This has potential major importance for this group of patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00469599....... vitamin D contributes to secondary hyperparathyroidism. Therefore, this condition is managed with activated vitamin D. However, hypercalcemia and hyperphosphatemia limit the use of activated vitamin D.In Denmark alfacalcidol is the primary choice of vitamin D analog.A new vitamin D analog, paricalcitol...... and hyperphosphatemia are associated with increased cardiovascular mortality in patients with chronic kidney disease.If there is any difference in the ability of these two vitamin D analogs to decrease the secondary hyperparathyroidism without causing hypercalcemia and hyperphosphatemia, there may also be a difference...

  9. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  10. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities.

    Science.gov (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel

    2017-10-01

    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

    Science.gov (United States)

    Neuzil, Kathleen M; Zaman, K; Victor, John C

    2014-08-11

    Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

  12. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial.

    Science.gov (United States)

    Sardella, Gennaro; Lucisano, Luigi; Garbo, Roberto; Pennacchi, Mauro; Cavallo, Erika; Stio, Rocco Edoardo; Calcagno, Simone; Ugo, Fabrizio; Boccuzzi, Giacomo; Fedele, Francesco; Mancone, Massimo

    2016-01-26

    A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction. The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization. In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year. The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups. In multivessel

  13. A combination of subcuticular suture and sterile Micropore tape compared with conventional interrupted sutures for skin closure. A controlled trial.

    Science.gov (United States)

    Taube, M.; Porter, R. J.; Lord, P. H.

    1983-01-01

    We have conducted a controlled trial to compare skin closure using conventional interrupted sutures with a combination of subcuticular suture and sterile Micropore tape in 169 patients undergoing appendicectomy, inguinal herniorrhaphy, or saphenofemoral ligation. We have found that the combination technique consistently gives a better cosmetic result and that the tape acts well as a dressing, is convenient, and is well tolerated by patients. Images Fig. 1 Fig. 2 Fig. 3 Fig. 4 PMID:6344732

  14. 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

  15. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    Science.gov (United States)

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  16. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  17. A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy

    LENUS (Irish Health Repository)

    Mullaney, L.

    2014-01-10

    Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients’ satisfaction with the bladder-filling instructions.

  18. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    Science.gov (United States)

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

  19. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  20. The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Aziz, Zoriah; Abdul Rasool Hassan, Bassam

    2017-02-01

    Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  1. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    Science.gov (United States)

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. A comparative trial of psychotherapy and pharmacotherapy for "pure" dysthymic patients.

    Science.gov (United States)

    Markowitz, John C; Kocsis, James H; Bleiberg, Kathryn L; Christos, Paul J; Sacks, Michael

    2005-12-01

    Psychotherapy of "pure" dysthymic disorder remains understudied. This article reports outcomes of an acute randomized trial of 94 subjects treated for 16 weeks with either interpersonal psychotherapy (IPT), brief supportive psychotherapy (BSP), sertraline, or sertraline plus IPT. Recruited by clinical referral and advertising, subjects met DSM-IV criteria for early onset dysthymic disorder, with no episode of major depression in the prior six months. They were randomly assigned to one of four 16-week treatments, with options for crossover or continuation treatment. Results were analyzed from the intention-to-treat sample by ANCOVA, controlling for baseline depressive severity. Subjects improved in all conditions over time, with the cells including sertraline pharmacotherapy showing superiority over psychotherapy alone for response and remission. Response rates were 58% for sertraline alone, 57% for combined treatment, 35% for IPT, and 31% for BSP. The study was underpowered and may have employed too "active" a control condition. Follow-up data were unobtainable. In this acute trial for "pure" dysthymic disorder, sertraline with or without IPT showed advantages relative to IPT and BSP. Methodological difficulties may have limited differential outcome findings. This study bolsters a small but growing literature on the treatment of dysthymic disorder, suggesting that pharmacotherapy may acutely benefit patients more than psychotherapy.

  3. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

    Science.gov (United States)

    Bryant, S R; Walton, J N; MacEntee, M I

    2015-01-01

    The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856). © International & American Associations for Dental Research 2014.

  4. Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial

    DEFF Research Database (Denmark)

    Crivellari, D.; Sun, Z.; Coates, A.S.

    2008-01-01

    PURPOSE: To explore potential differences in efficacy, treatment completion, and adverse events (AEs) in elderly women receiving adjuvant tamoxifen or letrozole for five years in the Breast International Group (BIG) 1-98 trial. METHODS: This report includes the 4,922 patients allocated to 5 years...... of letrozole or tamoxifen in the BIG 1-98 trial. The median follow-up was 40.4 months. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis was used to examine the patterns of differences in disease-free survival and incidences of AEs according to age. In addition, three categoric age groups were...... had superior efficacy (DFS) compared with tamoxifen in all age groups. On the basis of a small number of patients older than 75 years (6%), age per se should not unduly affect the choice of adjuvant endocrine therapy Udgivelsesdato: 2008/4/20...

  5. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-11-01

    Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score definition), or GCSdefinition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), pdefinition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. This trial suggests a potential mortality reduction in patients with blunt trauma with GCSdefinition only). Confirmatory studies which also address non-compliance issues are needed. NCT00112398. 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.

  6. Dropout Rates in Randomized Clinical Trials of Antipsychotics: A Meta-analysis Comparing First- and Second-Generation Drugs and an Examination of the Role of Trial Design Features

    OpenAIRE

    Rabinowitz, Jonathan; Levine, Stephen Z.; Barkai, Orna; Davidov, Ori

    2008-01-01

    Dropout is often used as an outcome measure in clinical trials of antipsychotic medication. Previous research is inconclusive regarding (a) differences in dropout rates between first- and second-generation antipsychotic medications and (b) how trial design features reduce dropout. Meta-analysis of randomized controlled trials (RCTs) of antipsychotic medication was conducted to compare dropout rates for first- and second-generation antipsychotic drugs and to examine how a broad range of design...

  7. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

    Science.gov (United States)

    Ragni, Margaret V

    2011-01-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

  8. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    BACKGROUND: Preoperative oral carbohydrate can attenuate postoperative insulin resistance and catabolism, and may have the potential to improve postoperative recovery. There are no data from randomized studies on postoperative clinical outcome after specific surgical procedures. This study...... evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  9. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel.

    Science.gov (United States)

    Rongetti, Regiane Ladislau; Oliveira e Castro, Paulo de Tarso; Vieira, Renê Aloisio da Costa; Serrano, Sérgio Vicente; Mengatto, Mariana Fabro; Fregnani, José Humberto Tavares Guerreiro

    2014-01-01

    To evaluate the incidence of surgical site infection (SSI) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues. Observer-blind, randomized equivalence clinical trial with two arms (electrocautery versus conventional scalpel) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery. A simple randomization stratified by body mass index (BMI: 30 kg/m(2)) was carried out. Women were evaluated at 14 and 30 days following the operation. A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI. Group arms were balanced for all variables, excepted for surgical time, which was significantly higher in the electrocautery group (mean: 161.1 versus 203.5 min, P = 0.029). The rates of SSI were 7.4% and 9.7%, respectively, for the conventional scalpel and electrocautery groups (P = 0.756). The exploratory multivariate model identified body mass index ≥30 kg/m(2) (OR = 24.2, 95% CI: 2.8-212.1) and transverse surgical incision (OR = 8.1, 95% CI: 1.5-42.6) as independent risk factors for SSI. The type of scalpel used in surgery, when adjusted for these variables and the surgery time, was not a risk factor for SSI. This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different. These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI. NCT01410175 (Clinical Trials - NIH). Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  10. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-01-01

    Background Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Methods Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. Results 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. Trial registration number NCT00112398. PMID:25795741

  11. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856.

    Science.gov (United States)

    Shubert, Christopher R; Ferrone, Christina R; Fernandez-Del Castillo, Carlos; Kendrick, Michael L; Farnell, Michael B; Smoot, Rory L; Truty, Mark J; Que, Florencia G

    2016-11-01

    Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Zeng, Yuxiao; Zhang, Xuecheng; Zhou, Jing; Wang, Xinwei; Jiao, Ruimin; Liu, Zhishun

    2018-05-01

    To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

  13. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  14. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    Science.gov (United States)

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

  15. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  16. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  17. Report of a randomized trial of d(15)+Be neutrons compared with megavoltage X ray therapy of bladder cancer

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Jack, W.J.; MacDougall, R.H.; Quilty, P.M.; Rodger, A.; Kerr, G.R.; Williams, J.R.

    1985-01-01

    The results of a randomized trial of d(15)+Be neutrons compared with 4 or 6 MV photons for the treatment of transitional cell carcinoma of the bladder. Between December 1978 and December 1981, 113 patients were accrued, 53 allocated to be treated by neutrons and 60 by photons. Complete local tumor regression was observed in 64% of patients treated by neutrons and 62% treated by photons. Recurrent cancer was subsequently confirmed in 31% of patients, similar in both treatment groups. There was no significant difference in the control rates by T stage between the two treatment groups. Late morbidity was significantly worse in patients treated by neutrons. Following neutron therapy, 78% of patients had serious late morbidity in at least one tissue compared with 38% in the group treated by photons. Survival was significantly better in the photon treated group 45.3% (+/- 11%) at 5 years compared with 12% (+/- 6%) after neutron therapy

  18. Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial

    DEFF Research Database (Denmark)

    Metzger Filho, Otto; Giobbie-Hurder, Anita; Mallon, Elizabeth

    2015-01-01

    assigned onto the Breast International Group (BIG) 1-98 trial and who had centrally reviewed pathology data were included (N = 2,923). HER2-negative IDC and ILC were additionally classified as hormone receptor-positive with high (luminal B [LB] -like) or low (luminal A [LA] -like) proliferative activity......PURPOSE: To evaluate the relative effectiveness of letrozole compared with tamoxifen for patients with invasive ductal or lobular carcinoma. PATIENTS AND METHODS: Patients diagnosed with early-stage invasive ductal carcinoma (IDC) or classic invasive lobular carcinoma (ILC) who were randomly...

  19. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  20. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    Science.gov (United States)

    2015-10-01

    score >45. Exclusion criteria: Service related trauma within last 3 months, history of schizophrenia, bipolar disorder , dementia, moderate or severe...7.7% 0.0% 8.3% 0.191 Bipolar disorder , % 7.7% 10.3% 13.9% 0.681 Substance use disorder , % 30.8% 43.6% 41.7% 0.458 Major depressive disorder ...Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in

  1. The effect of a trunk release maneuver on Peak Pressure Index, trunk displacement and perceived discomfort in older adults seated in a high Fowler’s position: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Best Krista L

    2012-11-01

    Full Text Available Abstract Background Pressure ulcers pose significant negative individual consequences and financial burden on the healthcare system. Prolonged sitting in High Fowler’s position (HF is common clinical practice for older adults who spend extended periods of time in bed. While HF aids in digestion and respiration, being placed in a HF may increase perceived discomfort and risk of pressure ulcers due to increased pressure magnitude at the sacral and gluteal regions. It is likely that shearing forces could also contribute to risk of pressure ulcers in HF. The purpose of this study was to evaluate the effect of a low-tech and time-efficient Trunk Release Manuever (TRM on sacral and gluteal pressure, trunk displacement and perceived discomfort in ambulatory older adults. Method A randomized controlled trial was used. We recruited community-living adults who were 60 years of age and older using posters, newspaper advertisements and word-of-mouth. Participants were randomly allocated to either the intervention or control group. The intervention group (n = 59 received the TRM, while the control group (n = 58 maintained the standard HF position. Results The TRM group had significantly lower mean (SD PPI values post-intervention compared to the control group, 59.6 (30.7 mmHg and 79.9 (36.5 mmHg respectively (p = 0.002. There was also a significant difference in trunk displacement between the TRM and control groups, +3.2 mm and −5.8 mm respectively (p = 0.005. There were no significant differences in perceived discomfort between the groups. Conclusion The TRM was effective for reducing pressure in the sacral and gluteal regions and for releasing the trunk at the point of contact between the skin and the support surface, but did not have an effect on perceived discomfort. The TRM is a simple method of repositioning which may have important clinical application for the prevention of pressure ulcers that may occur as a result of HF.

  2. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

    Science.gov (United States)

    Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

    2016-12-01

    There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating

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

    Science.gov (United States)

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

    2015-01-01

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

  4. Simultaneous occurrence of a severe Morel-Lavallée lesion and gluteal muscle necrosis as a sequela of transcatheter angiographic embolization following pelvic fracture: a case report.

    Science.gov (United States)

    Shimizu, Takayoshi; Matsuda, Shuichi; Sakuragi, Atsushi; Tsukie, Tomio; Kawanabe, Keiichi

    2015-03-26

    Morel-Lavallée lesions are posttraumatic hemolymphatic collections caused by disruption of the interfascial planes between the subcutaneous soft tissue and muscle. Severe peripelvic Morel-Lavallée lesions have rarely been reported in the literature. By contrast, a number of cases of gluteal muscle necrosis following transcatheter angiographic embolization for pelvic fracture have been reported. Each entity can result in severe infection and sepsis, and the mortality rate in such cases is quite high. However, to date, no previous reports have described a case in which these life-threatening entities occurred simultaneously. A 32-year-old Asian man simultaneously developed severe peripelvic Morel-Lavallée lesions and gluteal muscle necrosis with sepsis following transcatheter angiographic embolization after an unstable pelvic fracture. Extremely large skin and soft tissue defects, which were untreatable with any commonly used flaps, were generated after repeated debridement. In addition, a deep-bone infection was suspected in his left fractured iliac bone, while motor function was almost completely lost in his left leg, possibly as a sequela of transcatheter angiographic embolization. As a result of his condition, a left hemipelvectomy was unavoidable. A pedicled fillet flap from his sacrificed left limb was used for the treatment of the defects and to provide a durable base for a prosthesis. Our patient survived and returned to his previous job 24 months after the surgery wearing a prosthetic left leg. As illustrated by the present case, severe peripelvic Morel-Lavallée lesions and gluteal muscle necrosis following transcatheter angiographic embolization can occur simultaneously after unstable pelvic fractures. Physicians should recognize that these entities can result in life-threatening sepsis and, therefore, should attempt to detect them as early as possible. When hemipelvectomy is unavoidable, a pedicled upper and lower leg in-continuity fillet flap may

  5. Risks to the Superior Gluteal Neurovascular Bundle During Iliosacral and Transsacral Screw Fixation: A Computed Tomogram Arteriography Study.

    Science.gov (United States)

    Maslow, Jed; Collinge, Cory A

    2017-12-01

    Iliosacral (IS) and transsacral (TS) screws are popular techniques to repair complicated injuries to the pelvis. The anatomy of the superior gluteal neurovasculature (SG NV bundle) is well described as running along the posterior ilium, providing innervation and perfusion to important abductor muscles. The method of pelvis fixation least likely to injure the SG NV bundle is unknown. Twenty uninjured patients with a contrasted computed tomogram of the pelvis and lower extremities (CTA) were evaluated. Starting points for an S1 IS screw and S1 and S2 TS screws were estimated on the "ghost" lateral CTA image for those pelvi with safe corridors (>9 mm diameter). The distance from the projected screw to the SG artery was measured. A distance of <3.65 mm (half of a 7.3-mm screw's diameter) was considered likely for NV bundle injury. Of 40 pelvi CTAs (single sides), 10 pelvi (25%) were determined to be inappropriate for an S1 TS screw. The average distances from the screw starting point and the artery were 25.3 mm (±9.2) for S1 IS, 12.4 mm (±9.0) for S1 TS, and 23.5 mm (±10.7) for S2 TS screws, respectively. Ten S1 TS screws (25%) and no S1 IS or S2 TS screws were projected to have caused injury to the SG NV bundle (P < 0.001). Inserting S1 IS and S2 TS screws put the SG NV anatomy at significantly less risk than S1 TS screws. This information may aid in choosing the "best" fixation option for patients with pelvic ring trauma requiring surgery.

  6. Prospective Randomized Controlled Trial Comparing Plasmakinetic Vaporesection and Conventional Transurethral Resection of the Prostate

    Directory of Open Access Journals (Sweden)

    Berry Tat-Chow Fung

    2005-01-01

    Conclusion: PKVP achieved comparable results to traditional TURP and was an effective and safe procedure. However, it did not demonstrate obvious advantages over TURP in this acute regional hospital regular TURP list setting.

  7. Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.

    Science.gov (United States)

    Mason, J M; Thomas, K S; Ormerod, A D; Craig, F E; Mitchell, E; Norrie, J; Williams, H C

    2017-12-01

    Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT). To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm 2 ) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%. Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  8. Prospective randomized trial compares suction versus water seal for air leaks.

    Science.gov (United States)

    Cerfolio, R J; Bass, C; Katholi, C R

    2001-05-01

    Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

  9. Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Koleini

    2010-01-01

    Full Text Available Background: Letrozole is an aromatase inhibitor which can decrease estrogen production inperipheral tissues and endometriosis. Danazol, as an androgen, inhibits estrogen production inovaries and recently has been introduced as an aromatase inhibitor. This study was designed tocompare the effects of Danazol with Letrozole on endometriosis symptom relief.Materials and Methods: This study was a randomized clinical trial in which 105 patients withconfirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozoletablets (2.5 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 2 received Danazoltablets (600 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 3 (placebo groupwere assigned to take two calcium tablets daily (500 mg/tablet and vitamin D (800 IU/day. Pelvicpain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly duringthe study for a total of six months. Data were analyzed via SPSS version 15 software with Freidmanand Wilcoxon tests.Results: Mean age in three groups has no significant difference. Of the 105 participants who wereenrolled in this study, 38 patients were assigned to group 1 (Letrozole group, 37 patients in group 2(Danazol group and 31 patients were placed in group 3 (placebo group. This study showed that themean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group wereless than the Danazol and placebo groups.Conclusion: This study showed that Letrozole can be more effective than Danazol for reducingchronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis(Registeration Number: IRCT138812043414N1.

  10. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    Science.gov (United States)

    Edwards, Meghan K; Loprinzi, Paul D

    2018-03-01

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  11. Comparing the analgesic effect of heat patch containing iron chip and ibuprofen for primary dysmenorrhea: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Navvabi Rigi Shahindokht

    2012-08-01

    Full Text Available Abstract Background Primary dysmenorrhea is a common and sometimes disabling condition. In recent years, some studies aimed to improve the treatment of dysmenorrhea, and therefore, introduced several therapeutic measures. This study was designed to compare the analgesic effect of iron chip containing heat wrap with ibuprofen for the treatment of primary dysmenorrhea. Methods In this randomized (IRCT201107187038N2 controlled trial, 147 students (18–30 years old with the diagnosis of primary dysmenorrhea were enrolled considering the CONSORT guideline. Screening for primary dysmenorrhea was done by a two-question screening tool. The participants were randomly assigned into one of the intervention groups (heat Patch and ibuprofen. Data regarding the severity and emotional impact of the pain were recorded by a shortened version of McGill Pain Questionnaire (SF-MPQ. Student's t test was used for statistical analysis. Results The maximum and minimum pain severities were observed at 2 and 24 hours in both groups. The severity of sensual pain at 8, 12, and 24 hours was non-significantly less in the heat Patch group. There was also no significant difference between the groups regarding the emotional impact of pain at the first 2, 4, 8, 12 and 12 hours of menstruation. Conclusions Heat patch containing Iron chip has comparable analgesic effects to ibuprofen and can possibly be used for primary dysmenorrhea. Trial registration IRCT201107187038N2

  12. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    Science.gov (United States)

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years

  13. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

    NARCIS (Netherlands)

    van Santen, Marijke; Bolwijn, Paulien; Verstappen, Frans; Bakker, Carla; Hidding, Alita; Houben, Harry; van der Heijde, Desiree; Landewé, Robert; van der Linden, Sjef

    2002-01-01

    To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n =

  14. A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation

    NARCIS (Netherlands)

    Koster, Rudolph W.; Dorian, Paul; Chapman, Fred W.; Schmitt, Paul W.; O'Grady, Sharon G.; Walker, Robert G.

    2004-01-01

    Background We compared efficacy of and pain felt after biphasic truncated exponential (BTE) and monophasic damped sine (MDS) shocks in patients undergoing external cardioversion of atrial fibrillation (AF). Methods Patients with AF were randomized to BTE or MDS waveform cardioversion. Successive

  15. Brief Cognitive Behavioural Therapy compared to optimised general practitioners’ care for depression : A randomised trial

    NARCIS (Netherlands)

    Schene, A.H.; Baas, K.D.; Koeter, M.W.J.; Lucassen, P.; Bockting, C.L.H.; Wittkampf, K.A.; Huyser, J.; van Weert, H.C.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  16. Brief Cognitive Behavioural Therapy Compared to Optimised General Practitioners? Care for Depression: A Randomised Trial

    NARCIS (Netherlands)

    Schene, A. H.; Baas, K. D.; Koeter, M.; Lucassen, P.; Bockting, C. L. H.|info:eu-repo/dai/nl/258267992; Wittkampf, K. F.; van Weert, H. C.; Huyser, J.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  17. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...

  18. Sea state estimation from an advancing ship – A comparative study using sea trial data

    DEFF Research Database (Denmark)

    Nielsen, Ulrik Dam; Stredulinsky, David C.

    2012-01-01

    of a traditional wave rider buoy. The paper studies the ‘wave buoy analogy’, and a large set of full-scale motion measurements is considered. It is shown that the wave buoy analogy gives fairly accurate estimates of integrated sea state parameters when compared to corresponding estimates from real wave rider buoys...

  19. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Rajni Gupta

    2013-01-01

    Full Text Available Background: Hyperbaric ropivacaine produce more reliable sensory and motor block, with faster onset, better quality of muscles relaxation than isobaric ropivacaine. So, this study was designed to compare the efficacy of hyperbaric ropivacaine with isobaric ropivacaine in patients undergoing lower abdominal surgery. Methods: A randomized controlled double blind study in two groups of patients. group A (n=35 received 3 ml of isobaric ropivacaine 6 mg/ml (18 mg. Group B (n=35 received 3 ml of hyperbaric ropivacaine 6 mg/ml (18 mg. The onset and duration of sensory block at dermatome level T10, maximum upper and lower spread of sensory block, intensity, and duration of motor block were recorded. Statistical Analysis: Block characteristics were compared using the two-tailed Mann - Whitney U-test. The proportion of side effects was compared using the Chi-square test. Results: The median time of onset of sensory block at the T10 dermatome was 4.4±1.3 min in group B and 6.0±1.03 min in group A. The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B. The median duration of complete motor recovery (B0 was significantly shorter in the heavy ropivacaine group (166.5±11.7 min compared with the isobaric ropivacaine group (192.9±9.6 min. Conclusions: Intrathecal hyperbaric ropivacaine provides more rapid, adequate, and good quality of sensory and motor block with rapid post-operative recovery as compare to isobaric ropivacaine.

  20. A Comparative Clinical Trial of Topical Triamcinolone (Adcortyle and a Herbal Solution for the Treatment of Minor Aphthous Stomatitis

    Directory of Open Access Journals (Sweden)

    F Rad

    2010-10-01

    The aim of this study was to compare the therapeutic effect of topical Myrtus communis (myrtle solution with topical triamcinolone (Adcortyle in the treatment of minor apotheosis. Materials & Methods: This clinical-trial study was conducted at Kurdistan University of Medical Sciences in 2009. 100 patients were randomly assigned into 2 groups. The 1st group received topical myrtle solution. The 2nd group received topical trimcinolone (Adcortyle. After one week, patients' declaration about time of the recovery of the pain and deterioration of oral lesion was recorded. The gathered data was then analyzed using the SPSS statistical software using t-test and chi-square. Results: After treatment, both groups showed response to topical medications with no significant difference between them (p>0.05. Conclusion: results of this study showed that topical myrtle solution is effective in the treatment of minor aphthous stomatitis and its therapeutic effect is comparable with topical triamcinolone (Adcortyle.

  1. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial.

    Science.gov (United States)

    Kempe, Allison; Saville, Alison; Dickinson, L Miriam; Eisert, Sheri; Reynolds, Joni; Herrero, Diana; Beaty, Brenda; Albright, Karen; Dibert, Eva; Koehler, Vicky; Lockhart, Steven; Calonge, Ned

    2013-06-01

    We compared the effectiveness and cost-effectiveness of population-based recall (Pop-recall) versus practice-based recall (PCP-recall) at increasing immunizations among preschool children. This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD. Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P immunization rates in preschool children.

  2. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    Directory of Open Access Journals (Sweden)

    Gray Janine C

    2012-08-01

    Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

  3. Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-07-30

    The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic aresenal for this patient population, in terms of survival, local control, and complications. Overall survival, 85% at 2 years and local control, 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%), and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12) Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs 45% at 2 years (p = 0.03). The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. 33 refs., 3 figs., 5 tabs.

  4. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  5. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  6. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  7. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  8. Comparative clinical trial of castor oil and diclofenac sodium in patients with osteoarthritis.

    Science.gov (United States)

    Medhi, B; Kishore, K; Singh, U; Seth, S D

    2009-10-01

    A randomized, double-blind, comparative clinical study was conducted to compare the safety and efficacy of castor oil with diclofenac sodium in patients with knee osteoarthritis. Subjects with symptoms of knee osteoarthritis were given a castor oil capsule 0.9 mL (n = 50) thrice daily for 4 weeks or a capsule of diclofenac sodium (n = 50), 50 mg thrice daily for 4 weeks. The subjects completed an overall evaluation of symptom relief at 2 weeks and 4 weeks of completed treatment. The subjects were evaluated by clinical, routine laboratory and radiographic investigations for improvement of disease conditions and also for adverse drug reaction. On completion of 4 weeks treatment it was observed that both drugs were significantly effective in the treatment of knee osteoarthritis (p castor oil there were no adverse effects reported. The present study indicates that castor oil can be used as an effective therapy in primary knee osteoarthritis. (c) 2009 John Wiley & Sons, Ltd.

  9. Amitriptyline and intraoral devices for migraine prevention: a randomized comparative trial

    OpenAIRE

    Bruno, Marco A. D.; Krymchantowski, Abouch V.

    2018-01-01

    ABSTRACT Objectives: Nonpharmacological treatments, such as the Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), are approved for migraine prophylaxis. We aimed at evaluating the effectiveness of the NTI-tss and to compare its efficacy with amitriptyline and with a sham intraoral device in the preventive treatment of migraine. Methods: Consecutive patients with migraine were randomized to receive 25 mg of amitriptyline/day (n = 34), NTI-tss (n = 33) and a non-occlusal...

  10. Scientific writing: a randomized controlled trial comparing standard and on-line instruction

    OpenAIRE

    Phadtare, Amruta; Bahmani, Anu; Shah, Anand; Pietrobon, Ricardo

    2009-01-01

    Abstract Background Writing plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing. Methods Forty eight participants from a medical, nursing and physiotherapy background from US ...

  11. Randomised trial of elective continuous positive airway pressure (CPAP) compared with rescue CPAP after extubation

    OpenAIRE

    Robertson, N; Hamilton, P

    1998-01-01

    AIM—To determine if a weaning regimen on flow driver continuous positive airway pressure (CPAP) would decrease the number of ventilator days but increase the number of CPAP days when compared with a rescue regimen.
METHODS—Fifty eight babies of 24-32 weeks gestation with respiratory distress syndrome (RDS) were studied prospectively. After extubation they were randomly allocated to receive CPAP for 72 hours (n=29) according to a weaning regimen, or were placed in headbox ...

  12. Factors affecting patient participation in orthopaedic trials comparing surgery to non-surgical interventions

    Directory of Open Access Journals (Sweden)

    Rajat Mittal

    2016-08-01

    Conclusion: Patient non-participation in an RCT comparing surgery to no surgery is related to concern about receiving a treatment through chance and the presence of a strong preference for a particular treatment, particularly a non-surgical one. To avoid protracted recruitment periods, investigators can increase the number of study sites and ensure personnel involved have equipoise and are trained to provide a balanced view of both treatment arms.

  13. Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults.

    Science.gov (United States)

    Begovic, Begler; Ahmedtagic, Sead; Calkic, Lejla; Vehabović, Midhat; Kovacevic, Sanela Bakić; Catic, Tarik; Mehic, Meliha

    2016-12-01

    Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 10 7 live lyophilised lactic-acid bacteria) three times a day for three days. Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

  14. Scientific writing: a randomized controlled trial comparing standard and on-line instruction

    Directory of Open Access Journals (Sweden)

    Phadtare Amruta

    2009-05-01

    Full Text Available Abstract Background Writing plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing. Methods Forty eight participants from a medical, nursing and physiotherapy background from US and Brazil were randomly assigned to two groups (n = 24 per group: An on-line writing workshop group (on-line group, in which participants used virtual communication, google docs and standard writing templates, and a standard writing guidance training (standard group where participants received standard instruction without the aid of virtual communication and writing templates. Two outcomes, manuscript quality was assessed using the scores obtained in Six subgroup analysis scale as the primary outcome measure, and satisfaction scores with Likert scale were evaluated. To control for observer variability, inter-observer reliability was assessed using Fleiss's kappa. A post-hoc analysis comparing rates of communication between mentors and participants was performed. Nonparametric tests were used to assess intervention efficacy. Results Excellent inter-observer reliability among three reviewers was found, with an Intraclass Correlation Coefficient (ICC agreement = 0.931882 and ICC consistency = 0.932485. On-line group had better overall manuscript quality (p = 0.0017, SSQSavg score 75.3 ± 14.21, ranging from 37 to 94 compared to the standard group (47.27 ± 14.64, ranging from 20 to 72. Participant satisfaction was higher in the on-line group (4.3 ± 0.73 compared to the standard group (3.09 ± 1.11 (p = 0.001. The standard group also had fewer communication events compared to the on-line group (0.91 ± 0.81 vs. 2.05 ± 1.23; p = 0.0219. Conclusion Our protocol

  15. Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial.

    Science.gov (United States)

    Morris, Jonathan M; Roberts, Christine L; Bowen, Jennifer R; Patterson, Jillian A; Bond, Diana M; Algert, Charles S; Thornton, Jim G; Crowther, Caroline A

    2016-01-30

    Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity. The PPROMT trial was a multicentre randomised controlled trial done at 65 centres across 11 countries. Women aged over 16 years with singleton pregnancies and ruptured membranes before the onset of labour between 34 weeks and 36 weeks and 6 days weeks who had no signs of infection were included. Women were randomly assigned (1:1) by a computer-generated randomisation schedule with variable block sizes, stratified by centre, to immediate delivery or expectant management. The primary outcome was the incidence of neonatal sepsis. Secondary infant outcomes included a composite neonatal morbidity and mortality indicator (ie, sepsis, mechanical ventilation ≥24 h, stillbirth, or neonatal death); respiratory distress syndrome; any mechanical ventilation; and duration of stay in a neonatal intensive or special care unit. Secondary maternal outcomes included antepartum or intrapartum haemorrhage, intrapartum fever, postpartum treatment with antibiotics, and mode of delivery. Women and caregivers could not be masked, but those adjudicating on the primary outcome were masked to group allocation. Analyses were by intention to treat. This trial is registered with the International Clinical Trials Registry, number ISRCTN44485060. Between May 28, 2004, and June 30, 2013, 1839 women were recruited and randomly assigned: 924 to the immediate birth group and 915 to the expectant management group. One woman in the immediate birth group and three in the expectant group were excluded from the primary analyses. Neonatal sepsis occurred in 23 (2%) of 923 neonates whose mothers were assigned to immediate birth and 29

  16. Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.

    Science.gov (United States)

    Beall, Douglas P; Olan, Wayne J; Kakad, Priyanka; Li, Qianyi; Hornberger, John

    2015-01-01

    Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. A representative US hospital. Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva

  17. A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

    Science.gov (United States)

    Wiley, Henry E; Thompson, Darby J S; Bailey, Clare; Chew, Emily Y; Cukras, Catherine A; Jaffe, Glenn J; Lee, Richard W J; Loken, Erin K; Meyerle, Catherine B; Wong, Wai; Ferris, Frederick L

    2016-04-01

    To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design. Randomized, double-masked, 36-week, 3-period crossover clinical trial. Fifty-six subjects with DME involving the center of the macula in one or both eyes. Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model. Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and 6.6 letters for ranibizumab (difference, 1.3 letters; P = 0.039). Estimated change in optical coherence tomography (OCT) central subfield mean thickness (CSMT) was -89 μm for bevacizumab and -137 μm for ranibizumab (difference, 48 μm; P < 0.001). Incorporating cumulative treatment benefit, the model yielded a predicted 36-week (9-month) average improvement in visual acuity of 7.1 letters (95% confidence interval [CI], 5.0-9.2) for bevacizumab and 8.4 letters (95% CI, 6.3-10.5) for ranibizumab, and a change in OCT CSMT of -128 μm (95% CI, -155 to -100) for bevacizumab and -176 μm (95% CI, -202 to -149) for ranibizumab. There was no significant treatment-by-period interaction (i.e., treatment difference was constant in all 3 periods), nor was there a significant differential carryover effect from one period to the next. This trial demonstrated a statistically significant but small relative clinical benefit of ranibizumab compared with bevacizumab for treatment of DME, using a markedly reduced sample size relative to a full comparative efficacy study. The effects on visual acuity and central retinal thickness for the 2 drugs are consistent with those reported at 1 year for the concurrent parallel-group trial by the Diabetic Retinopathy Clinical Research Network testing bevacizumab

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

    Directory of Open Access Journals (Sweden)

    Lev-Tov Hadar

    2013-01-01

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

  19. Duodenum preserving pancreatectomy in chronic pancreatitis: Design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764

    Directory of Open Access Journals (Sweden)

    Reidel Margot A

    2006-05-01

    Full Text Available Abstract Background Chronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue. Beside obstructive jaundice and pseudocyst formation, about half of the patients need surgical intervention due to untreatable chronic pain during the course of the disease. In most of the patients with chronic pancreatitis, the head of the pancreas is the trigger of the chronic inflammatory process. Therefore, resection of pancreatic head tissue must be the central part of any surgical intervention. However, it is unclear to which extent the surgical procedure must be radical in order to obtain a favourable outcome for the patients. Design A single centre randomized controlled, superiority trial to compare two techniques of duodenum preserving pancreatic head resection. Sample size: 65 patients will be included and randomized intraoperatively. Eligibility criteria: All patients with chronic pancreatitis and indication for surgical resection and signed informed consent. Cumulative primary endpoint (hierarchical model: duration of surgical procedure, quality of life after one year, duration of intensive care unit stay, duration of hospital stay. Reference treatment: Resection of the pancreatic head with dissection of the pancreas from the portal vein and transsection of the gland (Beger procedure. Intervention: Partial Resection of the pancreatic head without transsection of the organ and visualization of the portal vein (Berne procedure. Duration: September 2003-October 2007. Organisation/responsibility The trial is conducted in compliance with the protocol and in accordance with the moral, ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and the Good Clinical Practice guideline (GCP. The Center for Clinical Studies of the Department of Surgery Heidelberg is responsible for planning, conducting and final

  20. Drug-induced acute interstitial nephritis: A clinicopathological study and comparative trial of steroid regimens

    Directory of Open Access Journals (Sweden)

    R Ramachandran

    2015-01-01

    Full Text Available Steroids are used in the management of drug-induced acute interstitial nephritis (AIN. The present study was undertaken to compare the efficacy of pulse methyl prednisolone with oral prednisolone in the treatment of drug-induced AIN. Patients with biopsy-proven AIN with a history of drug intake were randomized to oral prednisolone (Group 1 1 mg/kg for 3 weeks or a pulse methyl prednisolone (Group II 30 mg/kg for 3 days followed by oral prednisolone 1 mg/kg for 2 weeks, tapered over 3 weeks. Kidney biopsy scoring was done for interstitial edema, infiltration and tubular damage. The response was reported as complete remission (CR (improvement in estimated glomerular filtration rate [eGFR] to ≥60 ml/min/1.73 m 2 , partial remission (PR (improvement but eGFR <60 ml/min/1.73 m 2 or resistance (no CR/PR. A total of 29 patients, Group I: 16 and Group II: 13 were studied. Offending drugs included nonsteroidal anti-inflammatory drugs, herbal drugs, antibiotics, diuretic, rifampicin and omeprazole. There was no difference in the baseline parameters between the two groups. The biopsy score in Groups I and II was 5.9 ΁ 1.1 and 5.1 ΁ 1.2, respectively. At 3 months in Group I, eight patients each (50% achieved CR and PR. In Group II, 8 (61% achieved CR and 5 (39% PR. This was not significantly different. Percentage fall in serum creatinine at 1 week (56% was higher in CR as compared to (42% those with PR. ( P = 0.14. Patients with neutrophil infiltration had higher CR compared to patients with no neutrophil infiltration ( P = 0.01. Early steroid therapy, both oral and pulse steroid, is equally effective in achieving remission in drug-induced AIN.

  1. Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

    2008-01-01

    cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  2. Evaluation of automated nucleic acid extraction methods for virus detection in a multicenter comparative trial

    DEFF Research Database (Denmark)

    Rasmussen, Thomas Bruun; Uttenthal, Åse; Hakhverdyan, M.

    2009-01-01

    between the results obtained for the different automated extraction platforms. In particular, the limit of detection was identical for 9/12 and 8/12 best performing robots (using dilutions of BVDV infected-serum and cell culture material, respectively), which was similar to a manual extraction method used......Five European veterinary laboratories participated in an exercise to compare the performance of nucleic acid extraction robots. Identical sets of coded samples were prepared using serial dilutions of bovine viral diarrhoea virus (BVDV) from serum and cell culture propagated material. Each...

  3. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  4. COMPAR

    International Nuclear Information System (INIS)

    Kuefner, K.

    1976-01-01

    COMPAR works on FORTRAN arrays with four indices: A = A(i,j,k,l) where, for each fixed k 0 ,l 0 , only the 'plane' [A(i,j,k 0 ,l 0 ), i = 1, isub(max), j = 1, jsub(max)] is held in fast memory. Given two arrays A, B of this type COMPAR has the capability to 1) re-norm A and B ind different ways; 2) calculate the deviations epsilon defined as epsilon(i,j,k,l): =[A(i,j,k,l) - B(i,j,k,l)] / GEW(i,j,k,l) where GEW (i,j,k,l) may be chosen in three different ways; 3) calculate mean, standard deviation and maximum in the array epsilon (by several intermediate stages); 4) determine traverses in the array epsilon; 5) plot these traverses by a printer; 6) simplify plots of these traverses by the PLOTEASY-system by creating input data blocks for this system. The main application of COMPAR is given (so far) by the comparison of two- and three-dimensional multigroup neutron flux-fields. (orig.) [de

  5. Post-cholecystectomy alkaline reactive gastritis: a randomized trial comparing sucralfate versus rabeprazole or no treatment.

    Science.gov (United States)

    Santarelli, Luca; Gabrielli, Maurizio; Candelli, Marcello; Cremonini, Filippo; Nista, Enrico C; Cammarota, Giovanni; Gasbarrini, Giovanni; Gasbarrini, Antonio

    2003-09-01

    At present there are no well-established pharmacological approaches in the management of post-cholecystectomy alkaline reactive gastritis. The aim of this study was to assess the effect of sucralfate versus rabeprazole or no treatment on dyspeptic symptoms and endoscopic/histological signs in a population of patients with a history of cholecystectomy and evidence of alkaline reactive gastritis. Sixty dyspeptic patients fulfilling the following criteria of inclusion took part in this study: (1) a history of cholecystectomy; (2) no use of anti-inflammatory steroidal and non-steroidal drugs, or abuse of alcohol; (3) evidence of abundant gastric bile reflux at endoscopy; (4) endoscopic signs of chronic gastritis; (5) histological signs of chronic gastritis; and (6) absence of Helicobacter pylori infection. Dyspeptic symptoms were evaluated by means of a self-administered validated questionnaire. Patients included in the study were randomly assigned to one of three treatment groups for 3 months: sucralfate, rabeprazole, observation. Patients were re-evaluated at the end of the treatment. Sucralfate and rabeprazole therapies were both able to significantly reduce epigastric pain, heartburn, bloating and halitosis. Endoscopic/histological signs were lower in both treatment groups compared to the observation group. Both sucralfate and rabeprazole therapies are effective treatment options in the patients with alkaline gastritis when compared with observation.

  6. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners.

    Science.gov (United States)

    Hennessy, Joe; Garvey, Thérèse; Al-Awadhi, Ebrahim A

    2016-09-01

    To compare the mandibular incisor proclination produced by fixed labial appliances and third generation clear aligners. Patients underwent a course of orthodontic treatment using either fixed labial appliances or clear aligners (Invisalign). Mandibular incisor proclination was measured by comparing pretreatment and near-end treatment lateral cephalograms. Eligibility criteria included adult patients with mild mandibular incisor crowding (clear aligner group. Baseline characteristics were similar for both groups: Fixed appliance mean crowding was 2.1 ± 1.3 mm vs clear aligner mean crowding, 2.5 ± 1.3 mm; pretreatment mean mandibular incisor inclination for the fixed appliance group was 90.8 ± 5.4° vs 91.6 ± 6.4° for the clear aligner group. Fixed appliances produced 5.3 ± 4.3° of mandibular incisor proclination. Clear aligners proclined the mandibular incisors by 3.4 ± 3.2°. The difference between the two groups was not statistically significant (P > .05). There was no difference in the amount of mandibular incisor proclination produced by clear aligners and fixed labial appliances in mild crowding cases.

  7. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

    Science.gov (United States)

    Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

    2017-01-01

    Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

  8. Brodie’s Abscess of Posterior Ilium with Gluteal Syndrome, an Unusual Cause of Paediatric Low Back Pain: A Case Report

    Directory of Open Access Journals (Sweden)

    Behera G

    2017-07-01

    Full Text Available Brodie’s abscess is a variety of subacute osteomyelitis with a long duration of presentation and intermittent pain. It usually involves the metaphyseal region of long bones of the lower limbs. Brodie’s abscess of pelvic bone is very rare. Involvement of posterior ilium with gluteal syndrome is extremely unusual and can be easily missed or misdiagnosed. We present a 9-year old boy who reported to us with intermittent low back pain of three months duration without any other constitutional symptoms. Clinically, there was mild tenderness over the posterior ilium. Computed tomography showed a lytic lesion in the posterior ilium with a breach in the outer cortex. MRI and bone scan were suggestive of inflammatory pathology. Keeping infective, tubercular and benign bone tumors as differential diagnoses, open biopsy and curettage were done. Staphylococcus aureus was cultured and histopathology was suggestive of osteomyelitis. The patient received appropriate antibiotics for six weeks. He was asymptomatic till 18 months of follow up without any recurrence. We present this case because of its rarity and unusual presentation as gluteal syndrome and low back pain, and its resemblance to other pelvic and sacroiliac joint pathologies which are often missed or misdiagnosed in paediatric patients.

  9. Use of inferior gluteal artery and posterior thigh perforators in management of ischial pressure sores with limited donor sites for flap coverage.

    Science.gov (United States)

    Unal, Cigdem; Ozdemir, Jale; Yirmibesoglu, Oktay; Yucel, Ergin; Agir, Hakan

    2012-07-01

    Reconstructive surgery for ischial pressure sore defects presents a challenge because of high rates of recurrence. The aim of this study was to describe the use of inferior gluteal artery (IGA) and posterior thigh perforators in management of ischial pressure sores with limited donor sites. Between September 2005 and 2009, 11 patients (9 male, 2 female) with ischial sores were operated by using IGA and posterior thigh perforator flaps. The data of patients included age, sex, cause of paraplegia, flap size, perforator of flap, previous surgeries, recurrences, complications, and postoperative follow-up. Nine IGA and 5 posterior thigh perforator flaps were used. Six patients presented with recurrent lesions, 5 patients were operated for sacral and contralateral ischial pressure sores previously. In 2 patients, IGA and posterior thigh perforator flaps were used in combination. Patients were followed for an average of 34.3 months. In 2 recurrent cases, readvancement of IGA perforator flap and gluteus maximus myocutaneous flap were treatment of choice. Treatment of patients with recurrent lesions or multiple pressure sores is challenging because of limited available flap donor sites. In this study, posterior thigh perforator flaps were preferred in patients in whom the previous donor site was the gluteal region. IGA perforator flaps were the treatment of choice in patients for whom posterior thigh region was previously used. Alternately, preserved perforators of previous conventional myocutaneous flaps enabled us to use these perforators in recurrences.

  10. Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

    Science.gov (United States)

    Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

    2018-01-01

    Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

  11. Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

    Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

  12. Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

    International Nuclear Information System (INIS)

    Mariani, L.; Salvadori, B.; Marubini, E.; Conti, A.R.; Rovini, D.; Cusumano, F.; Rosolin, T.; Andreola, S.; Zucali, R.; Rilke, F.; Veronesi, U.

    1998-01-01

    We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192 Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR

  13. Treatment of helicobacter pylori infection; a controlled randomized comparative clinical trial

    International Nuclear Information System (INIS)

    Mehmood, A.; Usmanghani, K.; Mohiuddin, E.; Akram, M.

    2010-01-01

    Helicobacter pylori induces chronic inflammation of the underlying gastric mucosa and is strongly linked to the development of duodenal and gastric carcinoma. A study was conducted to evaluate the efficacy of Pylorex, a herbal formulation, for treatment of H. pylori infection as compared to triple allopathic therapy (Omeprazole, Amoxicillin, Metronidazole). The therapeutic evaluations of these medicines were conducted on 97 clinically and immunologically diagnosed cases of H. pylori infection. H. pylori was eradicated in 16 (32.6%) out of 49 patients by the use of triple allopathic therapy (Control drugs), and in 9 (18.7%) out of 48 patients by the use of Pylorex (Test drug). Pylorex possesses a therapeutic value for the treatment of H. pylori associated symptoms but the eradication rate is superior in triple allopathic therapy. (author)

  14. How to compare the social foundations of science culture: A trial with five cities in Korea.

    Science.gov (United States)

    Song, Jinwoong; Chung, Minkyung; Choi, Eunjeong; Kim, Leekyoung; Cho, Sook-Kyoung

    2013-01-01

    Though there have been several indicator systems to monitor the status quo of science and technology and of scientific literacy, few are especially designed for science culture, especially for its social dimension. Furthermore there is little agreement on how to measure it. In a previous study, an indicator system, SCI (Science Culture Indicators), had been developed to monitor the status quo of the science culture of a nation at both individual and social dimensions. The purpose of this study was to explore a practical way to measure and compare local cities' social foundation of science culture by revising and standardizing the social dimension of SCI and by applying it to five metropolitan cities in Korea. Despite some limits, the results of this study appear not only to reflect the cities' current situations but also to show the strength and weakness of their social foundation of science culture.

  15. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy

    Directory of Open Access Journals (Sweden)

    Anju Ghai

    2011-01-01

    Full Text Available Background: Pregabalin is a potent ligand for alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, which exhibits potent anticonvulsant, analgesic and anxiolytic activity. The pharmacological activity of pregabalin is similar to that of gabapentin and shows possible advantages. Although it shows analgesic efficacy against neuropathic pain, very limited evidence supports its postoperative analgesic efficacy. We investigated its analgesic efficacy in patients experiencing acute pain after abdominal hysterectomy and compared it with gabapentin and placebo. Methods: A randomized, double-blind, placebo-controlled study was conducted in 90 women undergoing abdominal hysterectomy who were anaesthetized in a standardized fashion. Patients received 300 mg pregabalin, 900 mg gabapentin or placebo, 1-2 hours prior to surgery. Postoperative analgesia was administered at visual analogue scale (VAS ≥3. The primary outcome was analgesic consumption over 24 hours and patients were followed for pain scores, time to rescue analgesia and side effects as secondary outcomes. Results: The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable. Moreover, the consumption of tramadol was statistically significant among all the groups. Patients in pregabalin and gabapentin groups had lower pain scores in the initial hour of recovery. However, pain scores were subsequently similar in all the groups. Time to first request for analgesia was longer in pregabalin group followed by gabapentin and control groups. Conclusion: A single dose of 300 mg pregabalin given 1-2 hours prior to surgery is superior to 900 mg gabapentin and placebo after abdominal hysterectomy. Both the drugs are better than placebo.

  16. No difference in outcome for open versus arthroscopic rotator cuff repair: a prospective comparative trial.

    Science.gov (United States)

    Bayle, Xavier; Pham, Thuy-Trang; Faruch, Marie; Gobet, Aurelie; Mansat, Pierre; Bonnevialle, Nicolas

    2017-12-01

    Arthroscopic techniques tend to become the gold standard in rotator cuff repair. However, little data are reported in the literature regarding the improvement of postoperative outcomes and re-tear rate relative to conventional open surgery. The aim of this study was to compare clinical outcomes and cuff integrity after arthroscopic versus open cuff repair. We prospectively assessed clinical outcomes and cuff integrity after an arthroscopic or open rotator cuff repair with a minimum follow-up of 12 months. Clinical evaluation was based on Constant score, Simple Shoulder Value (SSV) and American Shoulder and Elbow Score (ASES). Rotator cuff healing was explored with ultrasound. 44 patients in arthroscopic group A (mean age 56-year-old) and 43 in open group O (mean age 61-year-old) fulfilled the inclusion criteria. Tendons were repaired with a single row technique associated with biceps tenodesis and subacromial decompression. All objective clinical scores significantly improved postoperatively in both groups. No statistical difference was identified between group A and O regarding, respectively, Constant score (72 vs 75 points; p = 0.3), ASES score (88 vs 91 points; p = 0.3), and SSV (81 vs 85%). The overall rate of re-tear (Sugaya type IV or V) reached 7 and 9%, respectively, in group A and O (p = 0.8). This study did not prove any difference of arthroscopic over open surgery in case of rotator cuff repair regarding clinical outcome and cuff integrity at 1-year follow-up. Prospective comparative study.

  17. Treatment of travelers' diarrhea: randomized trial comparing rifaximin, rifaximin plus loperamide, and loperamide alone.

    Science.gov (United States)

    Dupont, Herbert L; Jiang, Zhi-Dong; Belkind-Gerson, Jaime; Okhuysen, Pablo C; Ericsson, Charles D; Ke, Shi; Huang, David B; Dupont, Margaret W; Adachi, Javier A; De La Cabada, F Javier; Taylor, David N; Jaini, Sridvya; Martinez Sandoval, Francisco

    2007-04-01

    Antimotility agents provide rapid temporary relief of acute diarrhea, whereas antibiotics slowly cure the illness. Thus, the combination of an antimotility agent and an antibiotic may provide greater therapeutic benefit than either drug alone. This study evaluated the efficacy and safety of rifaximin-loperamide in the treatment of travelers' diarrhea. Consenting adults with acute diarrhea (> or =3 unformed stools in 24 hours with > or =1 symptom of enteric infection) were randomized to receive rifaximin 200 mg 3 times daily for 3 days; loperamide 4 mg initially followed by 2 mg after each unformed stool; or a combination of both drugs using the same dosing regimen. The primary end point was the median time from beginning therapy until passing the last unformed stool. A total of 310 patients completed treatment with rifaximin (n = 102), loperamide (n = 104), or rifaximin-loperamide combination therapy (n = 104). The groups showed demographic similarity. Rifaximin and rifaximin-loperamide significantly reduced the median time until passage of the last unformed stool (32.5 +/- 4.14 h and 27.3 +/- 4.13 h, respectively) vs loperamide (69 +/- 4.11 h; P = .0019). The mean number of unformed stools passed during illness was lower with rifaximin-loperamide (3.99 +/- 4.28) compared with rifaximin (6.23 +/- 6.90; P = .004) or loperamide alone (6.72 +/- 6.93; P = .002). All treatments were well tolerated with a low incidence of adverse events. Rifaximin-loperamide therapy provided rapid symptomatic improvement and greater overall wellness compared with either agent alone.

  18. Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial.

    Science.gov (United States)

    Tsukayama, Hiroshi; Yamashita, Hitoshi; Amagai, Hitoshi; Tanno, Yasuo

    2002-12-01

    The objective of this study was to compare the effectiveness of electroacupuncture and TENS for low back pain when the electroacupuncture is applied in a clinically realistic manner. The study was designed as an evaluator-blinded randomised controlled trial (RCT). The study was performed at the Tsukuba College of Technology Clinic in Japan. Twenty subjects, who suffered from low back pain (LBP) without sciatica, were recruited, using leaflets in Tsukuba city. Subjects were allocated to either an electroacupuncture (EA) group (10 patients) or a transcutaneous electrical nerve stimulation (TENS) group (10 patients). The procedure for EA was in accordance with standard practice at our clinic. The main outcome measures were a pain relief scale (100 mm visual analogue scale: VAS) and a LBP score recommended by the Japanese Orthopaedic Association (JOA Score). Mean VAS value during the 2-weeks experimental period of the EA group was significantly smaller than that of the TENS group (65 mm vs 86 mm; 95% CI, 4.126 - 37.953). JOA Score in the EA group improved significantly while that in the TENS group showed no change. Although some placebo effect may be included, EA appeared more useful than TENS in the short-term effect on low back pain. We suggest that more realistic acupuncture interventions based on standard practice should be employed in pragmatic RCTs.

  19. Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

    Science.gov (United States)

    Schmidt, Ulrike; Ryan, Elizabeth G; Bartholdy, Savani; Renwick, Bethany; Keyes, Alexandra; O'Hara, Caitlin; McClelland, Jessica; Lose, Anna; Kenyon, Martha; Dejong, Hannah; Broadbent, Hannah; Loomes, Rachel; Serpell, Lucy; Richards, Lorna; Johnson-Sabine, Eric; Boughton, Nicky; Whitehead, Linette; Bonin, Eva; Beecham, Jennifer; Landau, Sabine; Treasure, Janet

    2016-08-01

    This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800). © 2016 Crown copyright. International Journal of Eating Disorders.

  20. Comparative effects of cholesteryl ester transfer protein inhibition, statin or ezetimibe on lipid factors: The ACCENTUATE trial.

    Science.gov (United States)

    Nicholls, Stephen J; Ray, Kausik K; Ballantyne, Christie M; Beacham, Lauren A; Miller, Debra L; Ruotolo, Giacomo; Nissen, Steven E; Riesmeyer, Jeffrey S

    2017-06-01

    The optimal approaches to management of patients treated with moderate statin doses on lipid parameters are unknown. The ACCENTUATE study aimed to compare the effects of adding the cholesteryl ester transfer protein inhibitor (CETP) evacetrapib, ezetimibe or increasing statin dose in atorvastatin-treated high-vascular risk patients on lipid parameters. 366 patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes were treated with atorvastatin 40 mg/day for 28 days prior to randomization to atorvastatin 40 mg plus evacetrapib 130 mg, atorvastatin 80 mg, atorvastatin 40 mg plus ezetimibe 10 mg or atorvastatin 40 mg plus placebo, daily for 90 days at 64 centers in the United States. Lipid parameters, safety and tolerability were measured. Addition of evacetrapib significantly reduced LDL-C (-33%) compared with ezetimibe (-27%, p=0.045), increasing statin dose (-6%) and statin alone (0%, pstatin dose (pstatin dose, and p=0.004 vs. statin alone). Addition of evacetrapib to atorvastatin produced an increase in hsCRP compared with ezetimibe (p=0.02). While evacetrapib improved traditional atherogenic and putative protective lipid measures compared with ezetimibe and increasing statin dose in patients with ASCVD and/or diabetes, it also adversely affected novel atherogenic risk factors. These findings may contribute to the lack of clinical benefit observed in the ACCELERATE trial. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. A Danish randomized trial comparing breast-preserving therapy with mastectomy in mammary carcinoma

    International Nuclear Information System (INIS)

    Blichert-Toft, M.; Brincker, H.; Andersen, J.A.; Andersen, K.W.; Axelsson, C.K.; Mouridsen, H.T.; Dombernowsky, P.; Overgaard, M.; Gadeberg, C.; Knudsen, G.; Borgeskov, S.; Bertelsen, S.; Knudsen, J.B.; Hansen, J.B.; Poulsen, P.E.; Willumsen, H.; Schousen, P.; Froberg, D.; Oernsholt, J.; Andersen, M.; Olesen, S.; Skovgaard, S.; Oester, M.; Schumacher, H.; Lynderup, E.K.; Holm, C.N.

    1988-01-01

    The present study comprises 847 women operated upon for invasive breast carcinoma at 19 surgical departments and enrolled in protocol DBCG-82TM from January 1983 to November 1987. Among them 662 (78%) were allocated for breast-preserving therapy or mastectomy by randomization, while 185 patients (22%) did not accept randomization. Within the randomized group 6% could not be entered into adjuvant protocols, i.e. subsequent programmes of postoperative therapy and follow-up. This left 619 evaluable patients. In the non-randomized series 26% did not fulfil the demands for entrance into the adjuvant protocols, leaving 136 evaluable patients, 60 of whom had chosen a breast-preserving operation and 76 mastectomy. In the randomized series the patients in the two treatment arms were comparable in age, menopausal status, site of tumour, pathoanatomical diameter of the tumour, number of removed axillary lymph nodes, number of metastatic axillary lymph nodes, and distribution on adjuvant regimens. Ninety per cent of the patients in the randomized group accepted the method offered, whereas 10% declined and wanted the alternate form of operation. The median follow-up period was approximately 1.75 years. The cumulative recurrence rate in the randomized group was 13% and in the non-randomized group 7%. These results are preliminary. Life-table analyses have not so far demonstrated differences in recurrence-free survival either in the randomized or the non-randomized series. (orig.)

  2. Amitriptyline and intraoral devices for migraine prevention: a randomized comparative trial

    Directory of Open Access Journals (Sweden)

    Marco A. D. Bruno

    Full Text Available ABSTRACT Objectives: Nonpharmacological treatments, such as the Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss, are approved for migraine prophylaxis. We aimed at evaluating the effectiveness of the NTI-tss and to compare its efficacy with amitriptyline and with a sham intraoral device in the preventive treatment of migraine. Methods: Consecutive patients with migraine were randomized to receive 25 mg of amitriptyline/day (n = 34, NTI-tss (n = 33 and a non-occlusal splint (n = 30. The headache frequency was evaluated at six and 12 weeks. Results: The amitriptyline group showed, respectively, 60% and 64% reduction in attack frequency at six and 12 weeks (P = 0.000. In the NTI-tss and non-occlusal splint groups, reduction was 39% and 30%, respectively, at six weeks and 48% for both groups at 12 weeks. Conclusions: Amitriptyline proved superior to the NTI-tss and the non-occlusal splint. Despite its approval by the United States Food and Drug Administration, the NTI-tss was not superior to a sham device.

  3. Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol.

    Science.gov (United States)

    Parabiaghi, A; Tettamanti, M; D'Avanzo, B; Barbato, A

    2016-01-01

    To determine whether the prescription of aripiprazole, compared with olanzapine and haloperidol, was associated with a lower frequency of metabolic syndrome (MS) and treatment discontinuation at 1 year. Patients were randomly assigned to be treated open-label and according to usual clinical practice with either aripiprazole, olanzapine, or haloperidol and followed up for 1 year. Three hundred out-patients with persistent schizophrenia were recruited in 35 mental health services. The intention-to-treat (ITT) analysis found no significant differences in the rate of MS between aripiprazole (37%), olanzapine (47%), and haloperidol (42%). Treatment discontinuation for any cause was higher for aripiprazole (52%) than for olanzapine (33%; OR, 0.41; P = 0.004), or haloperidol (37%; OR, 0.51; P = 0.030). No significant difference was found between olanzapine and haloperidol. Time to discontinuation for any cause was longer for olanzapine than for aripiprazole (HR, 0.55; P haloperidol and aripiprazole, or between olanzapine and haloperidol. The prescription of aripiprazole did not significantly reduce the rates of MS, but its treatment retention was worse. Aripiprazole cannot be considered the safest and most effective drug for maintenance treatment of schizophrenia in routine care, although it may have a place in antipsychotic therapy. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Randomised controlled trial comparing oral and intravenous paracetamol (acetaminophen) plasma levels when given as preoperative analgesia.

    Science.gov (United States)

    van der Westhuizen, J; Kuo, P Y; Reed, P W; Holder, K

    2011-03-01

    Gastric absorption of oral paracetamol (acetaminophen) may be unreliable perioperatively in the starved and stressed patient. We compared plasma concentrations of parenteral paracetamol given preoperatively and oral paracetamol when given as premedication. Patients scheduled for elective ear; nose and throat surgery or orthopaedic surgery were randomised to receive either oral or intravenous paracetamol as preoperative medication. The oral dose was given 30 minutes before induction of anaesthesia and the intravenous dose given pre-induction. All patients were given a standardised anaesthetic by the same specialist anaesthetist who took blood for paracetamol concentrations 30 minutes after the first dose and then at 30 minute intervals for 240 minutes. Therapeutic concentrations of paracetamol were reached in 96% of patients who had received the drug parenterally, and 67% of patients who had received it orally. Maximum median plasma concentrations were 19 mg.l(-1) (interquartile range 15 to 23 mg.l(-1)) and 13 mg.l(-1) (interquartile range 0 to 18 mg.l(-1)) for the intravenous and oral group respectively. The difference between intravenous and oral groups was less marked after 150 minutes but the intravenous preparation gave higher plasma concentrations throughout the study period. It can be concluded that paracetamol gives more reliable therapeutic plasma concentrations when given intravenously.

  5. Marrow transplantation for leukemia following fractionated total body irradiation. A comparative trial of methotrexate and cyclosporine

    International Nuclear Information System (INIS)

    Irle, C.; Deeg, H.J.; Buckner, C.D.; Swedish Hospital Medical Center, Seattle, WA; Veterans Administration Hospital, Seattle, WA; Washington Univ., Seattle

    1985-01-01

    Fifty-six patients, 30-47 yr of age, with leukemia in relapse received allogeneic marrow transplants from HLA-identical siblings. All patients were treated with cyclophosphamide (120 mg/kg) and 7 daily fractions of 2.25 Gy of total body irradiation (TBI) for seven consecutive days. Nine patients (16%) are currently alive, free of disease, 324-845 days from transplantation. Actuarial relapse and survival rates at 2 yr were 56% and 9.5% respectively. These data were not remarkably different from those in previous studies using 10 Gy of TBI administered as a single dose. Thirty patients were randomized to receive methotrexate (MTX) and 26 to receive cyclosporine (CSP) as postgrafting prophylaxis for acute graft-versus-host disease (GVHD). Probability of developing significant acute GVHD by day 100 post-transplant was 71% for patients in the MTX group and 45% for patients in the CSP group (p<0.05). Probability of relapse was 37% for patients in the MTX group and 70% for patients in the CSP group (p<0.05). Transplant-related deaths were more frequent in the MTX group and leukemic deaths more frequent in the CSP group although this may have been related to an uneven distribution of high-risk patients. Long term disease-free survival was comparable. (author)

  6. Treatment of childhood encopresis: a randomized trial comparing three treatment protocols.

    Science.gov (United States)

    Borowitz, Stephen M; Cox, Daniel J; Sutphen, James L; Kovatchev, Boris

    2002-04-01

    To compare short- and long-term effectiveness of three additive treatment protocols in children experiencing chronic encopresis. Children, 6 to 15 years of age, who experienced at least weekly fecal soiling for 6 months or longer were eligible for the study. Children were randomly assigned to a group that received intensive medical therapy (IMT), a group that received intensive medical therapy plus a behavior management program called enhanced toilet training (ETT), or a group that received intensive medical therapy with enhanced toilet training and external anal sphincter electromyographic biofeedback (BF). Data concerning toileting habits were collected for 14 consecutive days before an initial visit, and at 3, 6, and 12 months after initiation of therapy. All data were collected using a computerized voice-mail system that telephoned the families each day. At 12 months, children were classified as significantly improved (reduction in soiling, P 0.90, P encopresis than either intensive medical therapy or anal sphincter biofeedback therapy. Although similar total cure rates at 1 year can be expected with these three forms of therapy, enhanced toilet training results in statistically significant decreases in the daily frequency of soiling for the greatest number of children.

  7. Active learning on the ward: outcomes from a comparative trial with traditional methods.

    Science.gov (United States)

    Melo Prado, Hegla; Hannois Falbo, Gilliatt; Rodrigues Falbo, Ana; Natal Figueirôa, José

    2011-03-01

    Academic activity during internship is essentially practical and ward rounds are traditionally considered the cornerstone of clinical education. However, the efficacy and effectiveness of ward rounds for learning purposes have been under-investigated and it is necessary to assess alternative educational paradigms for this activity. This study aimed to compare the educational effectiveness of ward rounds conducted with two different learning methodologies. Student subjects were first tested on 30 true/false questions to assess their initial degree of knowledge on pneumonia and diarrhoea. Afterwards, they attended ward rounds conducted using an active and a traditional learning methodology. The participants were submitted to a second test 48hours later in order to assess knowledge acquisition and were asked to answer two questions about self-directed learning and their opinions on the two learning methodologies used. Seventy-two medical students taking part in a paediatric clinic rotation were enrolled. The active methodology proved to be more effective than the traditional methodology for the three outcomes considered: knowledge acquisition (33 students [45.8%] versus 21 students [29.2%]; p=0.03); self-directed learning (38 students [52.8%] versus 11 students [15.3%]; pmethods (61 students [84.7%] versus 38 students [52.8%]; ptraditional methodology in a ward-based context. This study seems to be valuable in terms of the new evidence it demonstrates on learning methodologies in the context of the ward round. © Blackwell Publishing Ltd 2011.

  8. Comparative randomised controlled clinical trial of a herbal eye drop with artificial tear and placebo in computer vision syndrome.

    Science.gov (United States)

    Biswas, N R; Nainiwal, S K; Das, G K; Langan, U; Dadeya, S C; Mongre, P K; Ravi, A K; Baidya, P

    2003-03-01

    A comparative randomised double masked multicentric clinical trial has been conducted to find out the efficacy and safety of a herbal eye drop preparation, itone eye drops with artificial tear and placebo in 120 patients with computer vision syndrome. Patients using computer for at least 2 hours continuosly per day having symptoms of irritation, foreign body sensation, watering, redness, headache, eyeache and signs of conjunctival congestion, mucous/debris, corneal filaments, corneal staining or lacrimal lake were included in this study. Every patient was instructed to put two drops of either herbal drugs or placebo or artificial tear in the eyes regularly four times for 6 weeks. Objective and subjective findings were recorded at bi-weekly intervals up to six weeks. Side-effects, if any, were also noted. In computer vision syndrome the herbal eye drop preparation was found significantly better than artificial tear (p computer vision syndrome.

  9. Sample size for comparing negative binomial rates in noninferiority and equivalence trials with unequal follow-up times.

    Science.gov (United States)

    Tang, Yongqiang

    2017-05-25

    We derive the sample size formulae for comparing two negative binomial rates based on both the relative and absolute rate difference metrics in noninferiority and equivalence trials with unequal follow-up times, and establish an approximate relationship between the sample sizes required for the treatment comparison based on the two treatment effect metrics. The proposed method allows the dispersion parameter to vary by treatment groups. The accuracy of these methods is assessed by simulations. It is demonstrated that ignoring the between-subject variation in the follow-up time by setting the follow-up time for all individuals to be the mean follow-up time may greatly underestimate the required size, resulting in underpowered studies. Methods are provided for back-calculating the dispersion parameter based on the published summary results.

  10. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial.

    Science.gov (United States)

    Smereka, Jacek; Ladny, Jerzy R; Naylor, Amanda; Ruetzler, Kurt; Szarpak, Lukasz

    2017-08-01

    The aim of this study was to compare C-MAC videolaryngoscopy with direct laryngoscopy for intubation in simulated cervical spine immobilization conditions. The study was designed as a prospective randomized crossover manikin trial. 70 paramedics with immobilization (Scenario A); manual inline cervical immobilization (Scenario B); cervical immobilization using cervical extraction collar (Scenario C). Scenario A: Nearly all participants performed successful intubations with both MAC and C-MAC on the first attempt (95.7% MAC vs. 100% C-MAC), with similar intubation times (16.5s MAC vs. 18s C-MAC). Scenario B: The results with C-MAC were significantly better than those with MAC (pimmobilization. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Clinical trial comparing autogenous fascia lata sling and Gore-Tex suspension in bilateral congenital ptosis

    Directory of Open Access Journals (Sweden)

    Elsamkary MA

    2016-03-01

    Full Text Available Mahmoud Ahmed Elsamkary,1 Maged Maher Salib Roshdy1,2 1Ophthalmology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 2Pediatric Ophthalmology Department, Al Watany Eye Hospital, Cairo, Egypt Purpose: To study the effect of autogenous fascia lata sling (AFLS versus Gore-Tex suspension (GTS regarding the functional and aesthetic outcomes in patients with bilateral congenital ptosis. Patients and methods: A prospective comparative randomized single-center study enrolled 110 patients with bilateral congenital ptosis. One group (n=55 underwent AFLS and the second group (n=55 underwent GTS. Exclusion criteria were good levator function, absent Bell’s phenomenon, and abnormal ocular motility. Follow-up period was 2 years. Functional outcome was measured from digital photos by analysis of upper eyelid margin position relative to the superior limbus and classified as very good (<3 mm, good (3–5 mm, poor (>5 mm, and recurrent. Aesthetic outcome was assessed in terms of lid contour, symmetry of eyelid height, and lid crease presence. Complications were also reported. Results: Failure rate (recurrence and complications was less in AFLS (P=0.035. Symmetrical lid height and good contour were more frequently attained by AFLS (P=0.007 and 0.047, respectively. However, the frequency of very good, good, poor, recurrence, lagopthalmos, ectropion, infection, and formed lid crease individually showed no statistically significant difference (P=0.252, 0.482, 1, 0.489, 0.438, 1, 0.618, and 0.506, respectively. Conclusion: AFLS is a better choice in surgery for patients with bilateral congenital ptosis because it has fewer complications and a lesser recurrence rate than GTS. Keywords: ptosis surgery, surgical outcomes, ptosis recurrence, lagophthalmos

  12. Prospectively randomized clinical trial to compare in situ and reversed saphenous vein grafts for femoropopliteal bypass.

    Science.gov (United States)

    Harris, P L; How, T V; Jones, D R

    1987-04-01

    Two hundred and fifteen femoropopliteal bypass procedures using autologous saphenous vein grafts were randomly allocated to either the reversed or in situ technique. Eleven veins (5 per cent) were rejected at operation on the basis of their small size, nine in the reversed group and two in the in situ group, and there were two (2 per cent) perioperative deaths in each group, leaving 102 reversed and 98 in situ grafts for further study. The cumulative patency at 3 years of the reversed grafts was 77 per cent and that of the in situ grafts was 68 per cent (n.s.). The patency of all grafts was affected adversely by small veins (P less than 0.005), long grafts (P less than 0.05), low volume of blood flow in the grafts (P less than 0.001) and poor run-off (P less than 0.05). These factors influenced the outcome of the in situ and reversed operations to a similar degree and there was no statistically significant difference between them within any subgroup. The mean compliance of the in situ grafts measured 3 months or more after operation with an ultrasonic echo-tracking system was 0.024 +/- 0.01 per cent/mmHg (+/- s.d.) compared with 0.017 +/- 0.01 per cent/mmHg for the reversed grafts (t = 2.43, P less than 0.02). The incidence of fibrous stricture formation as shown by intravenous digital subtraction angiography was 29 per cent in both the reversed and the in situ grafts. The results of the study to date indicate that reversed and in situ vein grafts are equally effective for femoropopliteal bypass.

  13. Randomized trial comparing rabeprazole- versus lansoprazole-based Helicobacter pylori eradication regimens.

    Science.gov (United States)

    Liu, Meng-Kwan; Wu, I-Chen; Lu, Chien-Yu; Kuo, Chao-Hung; Yu, Fang-Jung; Liu, Chung-Jung; Hsu, Ping-I; Hsu, Wen-Hung; Su, Yu-Chung; Chen, Angela; Wu, Deng-Chyang; Kuo, Fu-Chen; Chen, Jyh-Jou

    2013-07-01

    Different types of proton pump inhibitor (PPI)-based triple therapies could result in different Helicobacter pylori eradication rates. This study aimed to compare the efficacy and safety of rabeprazole- and lansoprazole-based triple therapies in primary treatment of H. pylori infection. From September 2005 to July 2008, 426 H. pylori-infected patients were randomly assigned to receive a 7-day eradication therapy with either rabeprazole 20mgbid (RAC group, n=222) or lansoprazole 30mgbid (LAC group, n=228) in combination with amoxicillin 1gbid and clarithromycin 500mgbid. The patients received follow-up esophagogastroduodenoscopy (EGD) and/or (13)C-urea breath test 12-16 weeks later to define H. pylori status. Their personal and medical history, compliance and side effects were obtained by using a standardized questionnaire. Intention-to-treat analysis revealed that the eradication rate was 87.84% in the RAC group and 85.96% in the LAC group (p=0.56). All patients returned for assessment of compliance (100% in the LAC group vs. 99.50% in the RAC group; p=0.32) and adverse events (7.20% in the RAC group vs. 5.70% in the LAC group, p=0.51). Univariate analysis suggested that patients with nonsteroid anti-inflammatory agent (NSAID) use had lower eradication rates than those without (76.71% vs. 88.74%; p=0.006). Our results showed that efficacy and safety were similar in rabeprazole- and lansoprazole-based primary therapies. The influence of NSAID usage on H. pylori eradication needs to be further investigated. Copyright © 2012. Published by Elsevier B.V.

  14. Polyetheretherketone (PEEK) Spacers for Anterior Cervical Fusion: A Retrospective Comparative Effectiveness Clinical Trial.

    Science.gov (United States)

    Lemcke, Johannes; Al-Zain, Ferass; Meier, Ullrich; Suess, Olaf

    2011-01-01

    Anterior cervical decompression and fusion (ACDF) is the standard surgical treatment for radiculopathy and myelopathy. Polyetheretherketone (PEEK) has an elasticity similar to bone and thus appears well suited for use as the implant in ACDF procedures. The aim of this study is to examine the clinical and radiographic outcome of patients treated with standing alone PEEK spacers without bone morphogenic protein (BMP) or plating and to examine the influence of the different design of the two spacers on the rate of subsidence and dislocation. This retrospective comparative study reviewed 335 patients treated by ACDF in a specialized urban hospital for radiculopathy or myelopathy due to degenerative pathologies. The Intromed PEEK spacer was used in 181 patients from 3/2002 to 11/2004, and the AMT SHELL spacer was implanted in 154 patients from 4/2004 to 12/2007. The follow-up rate was 100% at three months post-op and 82.7% (277 patients) at one year. The patients were assessed with the Japanese Orthopedic Association (JOA) questionnaire and radiographically. At the one-year follow-up there were 118/277 patients with an excellent clinical outcome on the JOA, 112/277 with a good outcome, 20/277 with a fair outcome, and 27/277 with a poor outcome. Subsidence was observed in 13.3% of patients with the Intromed spacer vs 8.4% of the patients with the AMT SHELL. Dislocation of the spacer was observed in 10 of the 181 patients with Intromed spacers but in none of the 154 patients with Shell spacers. The study demonstrates that ACDF with standing alone PEEK cages leads to excellent and good clinical outcomes. The differences we observed in the subsidence rate between the two spacers were not significant and cannot be related to a single design feature of the spacers.

  15. A randomized clinical trial to compare three methods of orthodontic space closure.

    Science.gov (United States)

    Dixon, V; Read, M J F; O'Brien, K D; Worthington, H V; Mandall, N A

    2002-03-01

    To compare the rates of orthodontic space closure for: Active ligatures, polyurethane powerchain (Rocky Mountain Orthodontics, RMO Europe, Parc d'Innovation, Rue Geiler de Kaysersberg, 67400 Illkirch-Graffenstaden, Strasbourg, France) and nickel titanium springs. Patients entering the space closure phase of fixed orthodontic treatment attending six orthodontic providers. Twelve patients received active ligatures (48 quadrants), 10 patients received powerchain (40 quadrants) and 11 patients, nickel-titanium springs (44 quadrants). Patients were randomly allocated for treatment with active ligatures, powerchain or nickel titanium springs. Upper and lower study models were collected at the start of space closure (T(o)) and 4 months later (T(1)). We recorded whether the patient wore Class II or Class III elastics. Space present in all four quadrants was measured, by a calibrated examiner, using Vernier callipers at T(o) and T(1.) The rate of space closure, in millimetres per month (4 weeks) and a 4-monthly rate, was then calculated. Examiner reliability was assessed at least 2 weeks later. Mean rates of space closure were 0.35 mm/month for active ligatures, 0.58 mm/month for powerchain, and 0.81 mm/month for NiTi springs. No statistically significant differences were found between any methods with the exception of NiTi springs showing more rapid space closure than active ligatures (P space closure. NiTi springs gave the most rapid rate of space closure and may be considered the treatment of choice. However, powerchain provides a cheaper treatment option that is as effective. The use of inter-arch elastics does not appear to influence rate of space closure.

  16. Results of a clinical trial comparing conservative and modified radical mastectomy for early breast cancer

    International Nuclear Information System (INIS)

    Du Xianghui; Wang Yuezhen; Wu Lie; Zhu Yuan; Yang Hongjian; Zou Dehong

    2005-01-01

    Objective: The influence of conservative mastectomy plus postoperative radiation (CM + RT) in local control, distant failure, cosmetic and psychological outcome for early stage breast cancer was evaluated comparing with modified radical mastectomy. Methods: Between January 1998 and December 2003, 68 early stage breast cancer patients underwent CM + RT. During the save period, 76 similar patients were treated by modified radical mastectomy (MRM + RT). The cosmetic results evaluated as 'excellent', 'fair' or 'poor' using specific guide lines together with their psychological changes. Sex life and marital stability were also recorded. All patients were female with median age of 44.5 years (range, 28-62 years). Guidelines for patient selection reported by National Breast Cancer Cooperative Group was adhered to. In general, CM consisted of wide local excision with the breast conserved and postoperative radiotherapy to the entire breast with tangential fields followed by a boost to the tumor bed. All patients also received adjuvant chemotherapy with CAF. Patients with positive ER or PR assay results received tamoxifen for 5 years. In the 76 MRM + RT patients, the post operative radiotherapy and chemotherapy were given as clinically indicated. Results: There was no failure locally in all. In CM + RT group, the cause of failure was bone metastasis in 1 and mutiple metastasis in 2. In the MRM + RT group, the cause of failure was bone metastasis in 2, brain metastasis in 1 and mutiple metastases in 1. The cosmetic scores were 91.2% excellent, 5.6% fair and 2.9% poor. Conclusions: Breast preservation by conservative mastectomy is preferable to mastectomy in appropriately selected patients as it provides equivalent survival but giving good cosmetic results. (authors)

  17. Randomized controlled clinical trial comparing two dental implants with different neck configurations.

    Science.gov (United States)

    Sanz-Martín, Ignacio; Sanz-Sánchez, Ignacio; Noguerol, Fernando; Cok, Susy; Ortiz-Vigón, Alberto; Sanz, Mariano

    2017-06-01

    Peri-implant bone levels can vary according to the implant neck macro-design and the implant-abutment interface. To compare the changes in soft and hard tissues when using a one-piece implant with a machined collar (TG) versus a two-piece implant with a progressive platform widening and a platform switching connection (SP). Partially edentulous patients willing to receive one or two implants in the posterior maxilla or mandible were randomized to the control (TG) or to the test group (SP). Final prostheses were delivered after 12 months. Radiographic measurements of interproximal bone levels (primary outcome) were assessed at implant loading and 1-year postloading. Clinical, patient related outcomes and adverse events were assessed at loading and after 6 and 12 months. Sixty-one implants were placed in 47 patients, 37 patients (18 in the TG group and 19 in the SP group), and 47 implants (23 TG and 24 SP) completed the 24-months follow up. At the patient level, a significantly greater bone resorption from baseline to implant loading was observed in the SP group (-0.42 ± 0.45 vs -0.07 ± 0.45; P = .001*), while from loading to the final visit, the TG group had significantly greater bone loss than the SP group (-0.26 ± 0.22 vs -0.11 ± 0.2; P = .020*). At 24 months after surgery, there were no significant differences between both groups (control: 0.33 ± 0.49 vs test: 0.53 ± 0.53; P = .230). Similarly, no significant differences were observed for the secondary outcomes. Both types of implant reported high survival rates and similar bone level changes, clinical parameters, and patient related outcomes after 12 months of loading. © 2017 Wiley Periodicals, Inc.

  18. HALF-DOSE DEPOT TRIPTORELIN COMPARABLE TO REDUCED DAILY BUSERELIN: A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. Safdarian

    2007-09-01

    Full Text Available Pituitary suppression by depot GnRH agonist may be excessive for ovarian stimulation. This study compares the efficacy of a single half-dose depot triptorelin and reduced-dose daily buserelin in a long protocol ICSI/ET. METHODS: A total of 182 patients were randomized into two groups using sealed envelopes. Pituitary desensitization was obtained in group 1 (91 patients with half-dose (1.87 mg depot triptorelin in the mid-luteal phase of their menstrual cycle, and in group 2 (91 patients with standard daily dose (0.5 mg buserelin, which was then reduced to 0.25 mg at the start of human menopausal gonadotropin (HMG stimulation. RESULTS: No significant differences were found among those who received HCG in terms of clinical pregnancy rate (34.4% in both groups, implantation rate (14.8% in group 1 versus 11.1% in group 2, fertilization rate (93.3 versus 95.6%, poor response rate (11.1 versus 6.7%, and miscarriage rate (11.1 versus 7.8%. No significant differences were seen in number of HMG ampoules used, follicles at HCG administration, and oocytes retrieved. The number of days of stimulation was significantly reduced in group 2 (11.2 +/- 1.8 in group 1 versus 10.6 +/- 1.9, p = 0.030. CONCLUSION: A half-dose of depot triptorelin can be successfully used in ovarian stimulation instead of reduced-dose daily buserelin, with more patient comfort and reduced stress and cost of injections.

  19. Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

    Science.gov (United States)

    Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

    2017-09-01

    To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-01-01

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

  1. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.

    Science.gov (United States)

    Wells, John A; Glassman, Adam R; Ayala, Allison R; Jampol, Lee M; Bressler, Neil M; Bressler, Susan B; Brucker, Alexander J; Ferris, Frederick L; Hampton, G Robert; Jhaveri, Chirag; Melia, Michele; Beck, Roy W

    2016-06-01

    To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. Copyright © 2016 American Academy of Ophthalmology. All rights

  2. Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania.

    Science.gov (United States)

    Thallinger, Monica; Ersdal, Hege Langli; Francis, Fortunata; Yeconia, Anita; Mduma, Estomih; Kidanto, Hussein; Linde, Jørgen Erland; Eilevstjønn, Joar; Gunnes, Nina; Størdal, Ketil

    2017-07-01

    Effective ventilation is crucial to save non-breathing newborns. We compared standard equipment for newborn resuscitation to a new Upright bag, in an area with high neonatal mortality. Newborns requiring resuscitation at Haydom Lutheran Hospital, Tanzania, were ventilated with 230ml standard or 320ml Upright bag-mask by weekly non-blinded block randomisation. A Laerdal Newborn Resuscitation Monitor collected ventilation data through a flow sensor between mask and bag and heart rate with electrocardiography electrodes. Primary outcome was expiratory tidal volume per birth weight. Of 6110 babies born, 136 randomised to standard bag-mask and 192 to Upright, both groups had similar birth weight, gestational age, Apgar scores, gender, and mode of delivery. Compared to standard bag-mask, Upright gave higher median expiratory tidal volume (8.6ml/kg (IQR: 3.5-13.8) vs. 10.0ml/kg (IQR: 4.3-16.8) difference ratio 1.29, 95%CI 1.05, 1.58, p=0.014)), increased mean airway and peak inspiratory pressures, and higher early expired CO 2 (median at 20s 4.2% vs. 3.2%, p=0.0099). Clinical outcome 30min post-delivery was normal in 44% with standard versus 57% with Upright (p=0.016), but similar at 24h. Upright provided higher expired tidal volume, MAP, PIP and early ECO 2 than the standard bag. Clinical outcome differed at 30min, but not at 24h. Larger volume of Upright than standard bag can be an important factor. The results are relevant for low- and high-income settings as ventilatory and heart rate parameters during resuscitation of newborns are rarely reported. Trial registered at www.ClinicalTrials.gov, NCT01869582. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed trials.

    Directory of Open Access Journals (Sweden)

    Melissa Paoloni

    Full Text Available Molecularly-guided trials (i.e. PMed now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting.A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77% successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days. Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type.Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week. Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical

  4. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control.

    Directory of Open Access Journals (Sweden)

    Donal G MacCoon

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

  5. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    Full Text Available Abstract Background Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Methods Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment. The two groups were followed up and blindly compared for early (after 3 months and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT, Chronic Liver Disease Questionnaire scores (CLDQ, Arizona Sexual Experience Scale scores (ASEX and the occurrence of any attributable adverse events were also compared. Results Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3% had a complete end of treatment virological response and 2 patients (6.7% had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12 and 3 months treatment (p = 0.22 by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group

  6. Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

    Science.gov (United States)

    Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

    2011-04-01

    Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the subgroup analysis of Microsporum species, data from only

  7. Ultrasonography and color Doppler of proximal gluteal enthesitis in juvenile idiopathic arthritis: a descriptive study

    Directory of Open Access Journals (Sweden)

    Thomsen Carsten

    2011-08-01

    Full Text Available Abstract Background The presence of enthesitis (insertional inflammation in patients with juvenile idiopathic arthritis (JIA is difficult to establish clinically and may influence classification and treatment of the disease. We used ultrasonography (US and color Doppler (CD imaging to detect enthesitis at the small and deep-seated proximal insertion of the gluteus medius fascia on the posterior iliac crest where clinical diagnosis is difficult. The findings in JIA patients were compared with those obtained in healthy controls and with the patients' MRI results. Methods Seventy-six proximal gluteus medius insertions were studied clinically (tenderness to palpation of the posterior iliac crest and by US and CD (echogenicity, thickness, hyperemia in 38 patients with JIA and in 38 healthy controls, respectively (median age 13 years, range 7-18 years. In addition, an additional MRI examination of the sacroiliac joints and iliac crests was performed in all patients. Results In patients with focal, palpable tenderness, US detected decreased echogenicity of the entheses in 53% of the iliac crests (bilateral in 37% and unilateral in 32%. US also revealed significantly thicker entheses in JIA patients compared to healthy controls (p Conclusions According to US, the gluteus medius insertion was thicker in JIA patients than in controls, and it was hypoechoic (enthesitis in about half of the patients. These findings may represent chronic, inactive disease in some of the patients, because there was only limited Doppler flow and MRI contrast enhancement. The present study indicates that US can be useful as an adjunct to clinical examination for improved assessment of enthesitis in JIA. This may influence disease classification, ambition to treat, and choice of treatment regimen.

  8. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    DEFF Research Database (Denmark)

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2009-01-01

    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%). CONCLUSION: Spontaneous improvement and effect of placebo contributed importantly...

  9. Point-of-care Ultrasound for the Diagnosis of a Gluteal Abscess

    Directory of Open Access Journals (Sweden)

    Kevin Roy

    2018-01-01

    Full Text Available History of present illness: A 57-year-old male with a history of intravenous drug use presented to the emergency department with four days of progressively worsening pain and swelling to his left buttock after injecting heroin subcutaneously (i.e., “skin popping”. Labs were significant for a white blood cell count (WBC of 26,700/mm3. Using the high frequency, linear probe, a point-of-care ultrasound (POCUS was performed and revealed a large soft tissue abscess. Significant findings: POCUS reveals a large, hypoechoic soft tissue abscess with debris and tracks extending to the bottom of the image. Furthermore, when compressed, movement of the abscess contents is appreciated. There is also superficial cobble-stoning consistent with overlying cellulitis and soft tissue edema. Discussion: In the United States, there are over 14 million outpatient visits per year related to soft tissue infections, with nearly one-third being seen in the emergency department.1,2 22%-65% of intravenous drug users experience abscesses and cellulitis.3 Soft tissue abscesses are commonly encountered in the emergency department and the diagnosis is often made by history and physical exam.5 However, imaging modalities are more accurate than physical exam alone. When comparing ultrasound to physical exam in the diagnosis of soft tissue abscesses, one study suggests that ultrasound has a sensitivity and specificity of 96% and 87%, respectively. The sensitivity and specificity of the physical exam is 84% and 60%, respectively.4 Another study comparing computed tomography (CT to ultrasound in the diagnosis of abscesses found ultrasound to have a sensitivity and specificity of 96.7% and 85.7%, respectively, while the overall sensitivity and specificity of CT was 76.7% and 91.4%, respectively. Ultrasound was superior in overall image detail ratings and demonstrated more visible detail within the abscess cavity. 5 When utilizing POCUS to evaluate for an abscess, look for an

  10. Differences in postprandial protein handling after beef compared with milk ingestion during postexercise recovery: a randomized controlled trial.

    Science.gov (United States)

    Burd, Nicholas A; Gorissen, Stefan H; van Vliet, Stephan; Snijders, Tim; van Loon, Luc Jc

    2015-10-01

    Protein consumed after resistance exercise increases postexercise muscle protein synthesis rates. To date, dairy protein has been studied extensively, with little known about the capacity of other protein-dense foods to augment postexercise muscle protein synthesis rates. We aimed to compare protein digestion and absorption kinetics, postprandial amino acid availability, anabolic signaling, and the subsequent myofibrillar protein synthetic response after the ingestion of milk compared with beef during recovery from resistance-type exercise. In crossover trials, 12 healthy young men performed a single bout of resistance exercise. Immediately after cessation of exercise, participants ingested 30 g protein by consuming isonitrogenous amounts of intrinsically l-[1-(13)C]phenylalanine-labeled beef or milk. Blood and muscle biopsy samples were collected at rest and after exercise during primed continuous infusions of l-[ring-(2)H5]phenylalanine and l-[ring-3,5-(2)H2]tyrosine to assess protein digestion and absorption kinetics, plasma amino acid availability, anabolic signaling, and subsequent myofibrillar protein synthesis rates in vivo in young men. Beef protein-derived phenylalanine appeared more rapidly in circulation compared with milk ingestion (P Nutrition.

  11. A randomized trial comparing surgeon-administered intraoperative transversus abdominis plane block with anesthesiologist-administered transcutaneous block.

    Science.gov (United States)

    Narasimhulu, D M; Scharfman, L; Minkoff, H; George, B; Homel, P; Tyagaraj, K

    2018-04-27

    Injection of local anesthetic into the transversus abdominis plane (TAP block) decreases systemic morphine requirements after abdominal surgery. We compared intraoperative surgeon-administered TAP block (surgical TAP) to anesthesiologist-administered transcutaneous ultrasound-guided TAP block (conventional TAP) for post-cesarean analgesia. We hypothesized that surgical TAP blocks would take less time to perform than conventional TAP blocks. We performed a randomized trial, recruiting 41 women undergoing cesarean delivery under neuraxial anesthesia, assigning them to either surgical TAP block (n=20) or conventional TAP block (n=21). Time taken to perform the block was the primary outcome, while postoperative pain scores and 24-hour opioid requirements were secondary outcomes. Student's t-test was used to compare block time and Kruskal-Wallis test opioid consumption and pain-scores. Time taken to perform the block (2.4 vs 12.1 min, P consumption (P=0.17) and postoperative pain scores at 4, 8, 24 and 48 h were not significantly different between the groups. Surgical TAP blocks are feasible and less time consuming than conventional TAP blocks, while providing comparable analgesia after cesarean delivery. Copyright © 2018 Elsevier Ltd. All rights reserved.

  12. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

  13. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    OpenAIRE

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-01

    Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

  14. Randomised controlled trial comparing early home biofeedback physiotherapy with pelvic floor exercises for the treatment of third-degree tears (EBAPT Trial).

    Science.gov (United States)

    Peirce, C; Murphy, C; Fitzpatrick, M; Cassidy, M; Daly, L; O'Connell, P R; O'Herlihy, C

    2013-09-01

    To compare early home biofeedback physiotherapy with pelvic floor exercises (PFEs) for the initial management of women sustaining a primary third-degree tear. Single centre, randomised trial. National Maternity Hospital, Dublin, Ireland. A total of 120 women sustaining a primary third-degree tear. Women were randomised in a one to three ratio: 30 to early postpartum home biofeedback physiotherapy and 90 to PFEs. Differences in anorectal manometry results, Cleveland Clinic continence scores and Rockwood faecal incontinence quality of life scale scores after 3 months of postpartum treatment. The mean anal resting pressure was 39 ± 13 mmHg in the early biofeedback physiotherapy group and 43 ± 17 mmHg in the PFE group. The mean anal squeeze pressure was 64 ± 17 mmHg in the biofeedback group and 62 ± 23 mmHg in the PFE group. There was no significant difference in anal resting and squeeze pressure values between the groups (P = 0.123 and P = 0.68, respectively). There were no differences in symptom score and quality of life measurements between the groups. This study demonstrates no added value in using early home biofeedback physiotherapy in the management of women sustaining third-degree tears. Poor compliance may have contributed because women found it difficult to designate time to using biofeedback. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

  15. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer.

    Science.gov (United States)

    Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G

    2007-08-20

    We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

  16. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone

    Energy Technology Data Exchange (ETDEWEB)

    Shipley, William U; Verhey, Lynn J; Munzenrider, John E; Suit, Herman D; Urie, Marcia M; McManus, Patricia L; Young, Robert H; Shipley, Jenot W; Zietman, Anthony L; Biggs, Peter J; Heney, Niall M; Goitein, Michael

    1995-04-30

    Purpose: Following a thorough Phase I/II study, we evaluated by a Phase III trial high versus conventional dose external beam irradiation as mono-therapy for patients with Stage T3-T4 prostate cancer. Patient outcome following standard dose radiotherapy or following a 12.5% increase in total dose to 75.6 Cobalt Gray Equivalent (CGE) using a conformal perineal proton boost was compared for local tumor control, disease-free survival, and overall survival. Methods and Materials: Stage T3-T4, Nx, N0-2, M0 patients received 50.4 Gy by four-field photons and were randomized to receive either an additional 25.2 CGE by conformal protons (arm 1--the high dose arm, 103 patients, total dose 75.6 CGE) or an additional 16.8 Gy by photons (arm 2--the conventional dose arm, 99 patients, total dose 67.2 Gy). Actuarial overall survival (OS), disease-specific survival (DSS), total recurrence-free survival (TRFS), (clinically free, prostate specific antigen (PSA) less than 4ng/ml and a negative prostate rebiopsy, done in 38 patients without evidence of disease) and local control (digital rectal exam and rebiopsy negative) were evaluated. Results: The protocol completion rate was 90% for arm 1 and 97% for arm 2. With a median follow-up of 61 months (range 3 to 139 months) 135 patients are alive and 67 have died, 20 from causes other than prostate cancer. We found no significant differences in OS, DSS, TRFS or local control between the two arms. Among those completing randomized treatment (93 in arm 1 and 96 in arm 2), the local control at 5 and 8 years for arm 1 is 92% and 77%, respectively and is 80% and 60%, respectively for arm 2 (p = .089) and there are no significant differences in OS, DSS, and TRFS. The local control for the 57 patients with poorly differentiated (Gleason 4 or 5 of 5) tumors at 5 and 8 years for arm 1 is 94% and 84% and is 64% and 19% on arm 2 (p 0.0014). In patients whose digital rectal exam had normalized following treatment and underwent prostate rebiopsy

  17. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone

    International Nuclear Information System (INIS)

    Shipley, William U.; Verhey, Lynn J.; Munzenrider, John E.; Suit, Herman D.; Urie, Marcia M.; McManus, Patricia L.; Young, Robert H.; Shipley, Jenot W.; Zietman, Anthony L.; Biggs, Peter J.; Heney, Niall M.; Goitein, Michael

    1995-01-01

    Purpose: Following a thorough Phase I/II study, we evaluated by a Phase III trial high versus conventional dose external beam irradiation as mono-therapy for patients with Stage T3-T4 prostate cancer. Patient outcome following standard dose radiotherapy or following a 12.5% increase in total dose to 75.6 Cobalt Gray Equivalent (CGE) using a conformal perineal proton boost was compared for local tumor control, disease-free survival, and overall survival. Methods and Materials: Stage T3-T4, Nx, N0-2, M0 patients received 50.4 Gy by four-field photons and were randomized to receive either an additional 25.2 CGE by conformal protons (arm 1--the high dose arm, 103 patients, total dose 75.6 CGE) or an additional 16.8 Gy by photons (arm 2--the conventional dose arm, 99 patients, total dose 67.2 Gy). Actuarial overall survival (OS), disease-specific survival (DSS), total recurrence-free survival (TRFS), (clinically free, prostate specific antigen (PSA) less than 4ng/ml and a negative prostate rebiopsy, done in 38 patients without evidence of disease) and local control (digital rectal exam and rebiopsy negative) were evaluated. Results: The protocol completion rate was 90% for arm 1 and 97% for arm 2. With a median follow-up of 61 months (range 3 to 139 months) 135 patients are alive and 67 have died, 20 from causes other than prostate cancer. We found no significant differences in OS, DSS, TRFS or local control between the two arms. Among those completing randomized treatment (93 in arm 1 and 96 in arm 2), the local control at 5 and 8 years for arm 1 is 92% and 77%, respectively and is 80% and 60%, respectively for arm 2 (p = .089) and there are no significant differences in OS, DSS, and TRFS. The local control for the 57 patients with poorly differentiated (Gleason 4 or 5 of 5) tumors at 5 and 8 years for arm 1 is 94% and 84% and is 64% and 19% on arm 2 (p 0.0014). In patients whose digital rectal exam had normalized following treatment and underwent prostate rebiopsy

  18. Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures.

    Science.gov (United States)

    Reynolds, Stacy L; Bryant, Kathleen K; Studnek, Jonathan R; Hogg, Melanie; Dunn, Connell; Templin, Megan A; Moore, Charity G; Young, James R; Walker, Katherine Rivera; Runyon, Michael S

    2017-12-01

    We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine. This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room. Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most

  19. Muscle energy technique compared to eccentric loading exercise in the management of achilles tendinitis: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hariharasudhan Ravichandran

    2017-01-01

    Full Text Available Background: Achilles tendinitis is a common overuse injury among both elite and recreational athletes involved in activities such as repetitive jumping and running. Aim: The aim of this single-blinded randomized study was to compare the efficacy of muscle energy technique (MET and eccentric loading exercise (ELE interventions on improving functional ability and pain reduction among athletes with Achilles tendinitis. Methods: A single-blinded, pilot, randomized study was conducted in the Department of Physical Therapy, Global Hospitals and Health City, India, with 6-week follow-up. A total of 30 patients with Achilles tendinitis were randomly allocated to receive either MET (n = 15 or ELE (n = 15 treatment. Treatment effects were evaluated by pre- and post-treatment assessment of visual analog scale (VAS and Victorian Institute of Sports Assessment-Achilles (VISA-A questionnaire. Measures were performed by single-blinded evaluators at baseline and at 2, 4, and after 6 weeks of treatment. Results: Both groups showed a significant difference in VAS after 6 weeks' ELE group showed a significant improvement during treatment at 2 and 4 weeks in comparison with MET group. The VISA-A scale score significantly improved in both groups. Yet, comparison of VISA scores between groups showed marginally significant difference (P = 0.012. Conclusion: This pilot randomized controlled trial (RCT showed the efficacy of ELE in reducing pain and improving functional ability among patients with Achilles tendinitis. The findings of this study provide the rationale for undertaking a large-scale RCT. A large sized trial is needed to establish evidence for clinical practice of ELE in Achilles tendinitis cases.

  20. Racemic epinephrine compared to salbutamol in hospitalized young children with bronchiolitis; a randomized controlled clinical trial [ISRCTN46561076

    Directory of Open Access Journals (Sweden)

    LeBlanc John C

    2005-05-01

    Full Text Available Abstract Background Bronchiolitis is the most common cause of lower respiratory tract illness in infancy, and hospital admission rates appear to be increasing in Canada and the United States. Inhaled beta agonists offer only modest short-term improvement. Trials of racemic epinephrine have shown conflicting results. We sought to determine if administration of racemic epinephrine during hospital stay for bronchiolitis improved respiratory distress, was safe, and shortened length of stay. Methods The study was a randomized, double-blind controlled trial of aerosolized racemic epinephrine compared to salbutamol every one to 4 hours in previously well children aged 6 weeks to ≤ 2 years of age hospitalized with bronchiolitis. The primary outcome was symptom improvement as measured by the Respiratory Distress Assessment Instrument (RDAI; secondary outcomes were length of stay in hospital, adverse events, and report of symptoms by structured parental telephone interview one week after discharge. Results 62 children with a mean age of 6.4 months were enrolled; 80% of children had Respiratory Syncytial Virus (RSV. Racemic epinephrine resulted in significant improvement in wheezing and the total RDAI score on day 2 and over the entire stay (p 0.05. Adverse events were not significantly different in the two arms. At one week post-discharge, over half of parents reported that their child still had a respiratory symptom and 40% had less than normal feeding. Conclusion Racemic epinephrine relieves respiratory distress in hospitalized infants with bronchiolitis and is safe but does not abbreviate hospital stay. Morbidity associated with bronchiolitis as identified by parents persists for at least one week after hospital discharge in most infants.

  1. Comparing Different Epinephrine Concentrations for Spinal Anesthesia in Cesarean Section: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arash Hamzei

    2015-07-01

    Full Text Available Background: Although various anesthetic techniques can be used in different kinds of surgeries, spinal anesthesia has received considerable attention for the lower abdomen and lower extremities surgeries and cesarean section. This study aimed at comparing the effect of adding epinephrine 1:1000 and 1:10000 to lidocaine and fentanyl in spinal anesthesia on the prolongation of paralysis, analgesia and hemodynamic changes in pregnant women candidate for cesarean section. Methods: A double blind randomized clinical trial was carried out on 66 pregnant women (equally sized control and treatment groups of 33 in 2011. After randomizing the participants into two groups of recipients of epinephrine 1:1000 plus lidocaine 5% and fentanyl (control group and recipients of epinephrine 1:10000 with lidocaine 5% and fentanyl, (treatment group, the participants’ systolic and diastolic blood pressure and heart rate were recorded before and 1, 3, 5, 10, 15 minutes after procedure. Besides the prolongation of paralysis and analgesia, the presence of postoperative nausea and vomiting were evaluated. The outcome of the study was analyzed using SPSS software and via t test, χ2 test and RMANOVA. Results: The mean age (standard deviation of the participants was 29.3 (4.4 and 28.2 (4.5 in the treatment and control groups, respectively. There were no statistical significance between the participants’ prolongation of paralysis, analgesia, the frequency of nausea and vomiting, and the average values of hemodynamic variables between the two groups. Conclusion: The use of epinephrine 1:10000 along with lidocaine and fentanyl is recommended in spinal anesthesia in pregnant women candidate for cesarean section. Trial Registration Number: IRCT201012225445N1.

  2. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

    Science.gov (United States)

    Geladé, Katleen; Janssen, Tieme W P; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-10-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally titrated methylphenidate and (2) a semi-active control intervention, physical activity, to account for nonspecific effects. A multicenter 3-way parallel-group study with balanced randomization was conducted. Children with a DSM-IV-TR diagnosis of ADHD, aged 7-13 years, were randomly allocated to receive neurofeedback (n = 39), methylphenidate (n = 36), or physical activity (n = 37) over a period of 10-12 weeks. Neurofeedback comprised theta/beta training on the vertex (Cz). Physical activity consisted of moderate to vigorous intensity exercises. Neurofeedback and physical activity were balanced in terms of number (~30) and duration of sessions. A double-blind pseudorandomized placebo-controlled crossover titration procedure was used to determine an optimal dose in the methylphenidate intervention. Parent and teacher ratings on the Strengths and Difficulties Questionnaire (SDQ) and Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) were used to assess intervention outcomes. Data collection took place between September 2010 and March 2014. Intention-to-treat analyses revealed an improvement in parent-reported behavior on the SDQ and the SWAN Hyperactivity/Impulsivity scale, irrespective of received intervention (ηp² = 0.21-0.22, P ≤ .001), whereas the SWAN Inattention scale revealed more improvement in children who received methylphenidate than neurofeedback and physical activity (ηp² = 0.13, P ≤ .001). Teachers reported a decrease of ADHD symptoms on all measures for methylphenidate, but not for neurofeedback or physical activity (range of ηp² = 0.14-0.29, P ADHD symptoms in children with ADHD. ClinicalTrials.gov identifier: NCT01363544. © Copyright

  3. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials.

    Science.gov (United States)

    Paoloni, Melissa; Webb, Craig; Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E J; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara; Khanna, Chand; Trent, Jeffrey

    2014-01-01

    Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (strategies may aid cancer drug development.

  4. Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Daoud, Jamel; Toumi, Nabil; Siala, Wissem; Ghorbel, Abdelmonem; Drira, Mohamed Mokthar; Frikha, Mounir

    2007-01-01

    Background and purpose: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. Patients and methods: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. Results: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p = 0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p = 0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p = 0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. Comments: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin

  5. At what price? A cost-effectiveness analysis comparing trial of labour after previous caesarean versus elective repeat caesarean delivery.

    Directory of Open Access Journals (Sweden)

    Christopher G Fawsitt

    Full Text Available BACKGROUND: Elective repeat caesarean delivery (ERCD rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. METHODS: Using a decision analytic model, a cost-effectiveness analysis (CEA was performed where the measure of health gain was quality-adjusted life years (QALYs over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations. RESULTS: Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively, and QALYs were modestly higher (0.84 versus 0.70. Our findings were supported by probabilistic sensitivity analysis. CONCLUSIONS: Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

  6. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

    Science.gov (United States)

    Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

    2012-12-01

    Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

  7. A virtual clinical trial comparing static versus dynamic PET imaging in measuring response to breast cancer therapy

    Science.gov (United States)

    Wangerin, Kristen A.; Muzi, Mark; Peterson, Lanell M.; Linden, Hannah M.; Novakova, Alena; Mankoff, David A.; E Kinahan, Paul

    2017-05-01

    We developed a method to evaluate variations in the PET imaging process in order to characterize the relative ability of static and dynamic metrics to measure breast cancer response to therapy in a clinical trial setting. We performed a virtual clinical trial by generating 540 independent and identically distributed PET imaging study realizations for each of 22 original dynamic fluorodeoxyglucose (18F-FDG) breast cancer patient studies pre- and post-therapy. Each noise realization accounted for known sources of uncertainty in the imaging process, such as biological variability and SUV uptake time. Four definitions of SUV were analyzed, which were SUVmax, SUVmean, SUVpeak, and SUV50%. We performed a ROC analysis on the resulting SUV and kinetic parameter uncertainty distributions to assess the impact of the variability on the measurement capabilities of each metric. The kinetic macro parameter, K i , showed more variability than SUV (mean CV K i   =  17%, SUV  =  13%), but K i pre- and post-therapy distributions also showed increased separation compared to the SUV pre- and post-therapy distributions (mean normalized difference K i   =  0.54, SUV  =  0.27). For the patients who did not show perfect separation between the pre- and post-therapy parameter uncertainty distributions (ROC AUC  dynamic imaging outperformed SUV in distinguishing metabolic change in response to therapy, ranging from 12 to 14 of 16 patients over all SUV definitions and uptake time scenarios (p  PET imaging.

  8. INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia

    Directory of Open Access Journals (Sweden)

    Gilmore Rose

    2010-01-01

    , strength and sensation, activity limitations (upper limb unimanual capacity and bimanual motor coordination, participation restrictions (in home, school and recreation, environmental (barriers and facilitators to participation and quality of life. Discussion This paper outlines the theoretical basis, study hypotheses and outcome measures for a matched pairs randomised trial comparing CIMT and BIM training to improve outcomes across the ICF. Trial Registration ACTRN12609000912280

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

    Science.gov (United States)

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

    2016-03-31

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

  10. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation.

    Science.gov (United States)

    Hsieh, Yu-Hsi; Tseng, Chih-Wei; Hu, Chi-Tan; Koo, Malcolm; Leung, Felix W

    2017-07-01

    Adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma of any size, is a quality indicator. We tested the hypothesis that water exchange (WE) improves ADR but water immersion (WI) has no adverse effect on ADR compared with air insufflation (AI). A prospective study was conducted at the Dalin Tzu Chi Hospital in southern Taiwan and the Hualien Tzu Chi Hospital in eastern Taiwan on patients randomly assigned to WE, WI, or AI with stratification by the 3 study colonoscopists. The primary outcome was ADR. From July 2013 to December 2015, 651 patients were recruited and randomized into 3 groups with a 1:1:1 ratio (217 patients per group). Overall, ADR met quality standards: WE 49.8% (95% CI, 43.2%-56.4%), AI 37.8% (95% CI, 31.6%-44.4%), and WI 40.6% (95% CI, 34.2%-47.2%). Compared with AI, WE significantly increased ADR (P = .016). There was no difference between WI and WE. ADRs of WI and AI were comparable. Compared with AI, WE confirmed a longer insertion time, higher cleanliness score, but similar adenoma per positive colonoscopy (APPC) and withdrawal time with polypectomy. Subgroup analysis found WE significantly increased ADR in propofol-sedated patients. Multivariate generalized linear mixed model analysis revealed that age ≥50 years, WE (vs AI), colonoscopy indication, no previous history of colonoscopy, and withdrawal time >8 minutes were significant predictors of increased ADR. Confirmation of prior reports showing WE, but not WI, increased ADR further strengthened the validity of our observations. WE significantly increased ADR in propofol-sedated patients. The outcome differences justify assessment of the role of WE in colorectal cancer prevention. Similar APPC and withdrawal times suggest that adequate inspection was performed on colonoscope withdrawal in each of the study arms. (Clinical trial registration number: NCT01894191.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.

  11. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.

    Science.gov (United States)

    Jeuken, Ralph M; Schotanus, Martijn G M; Kort, Nanne P; Deenik, Axel; Jong, Bob; Hendrickx, Roel P M

    2016-07-01

    Hallux valgus is one of the most common foot deformities. This long-term follow-up study compared the results of 2 widely used operative treatments for hallux valgus: the scarf and chevron osteotomy. Conventional weight bearing anteroposterior (AP) radiographs of the foot were made for evaluating the intermetatarsal angle and hallux valgus angle. For clinical evaluation, the American Orthopaedic Foot & Ankle Society (AOFAS) rating system for the hallux metatarsophalangeal-interphalangeal scale was used together with physical examination of the foot. These data were compared with the results from the original study. The Short Form 36 questionnaire, the Manchester-Oxford Foot Questionnaire (MOXFQ), and a general questionnaire including a visual analog scale (VAS) pain score were used for subjective evaluation. The primary outcome measures were the radiologic recurrence of hallux valgus and reoperation rate of the same toe. Secondary outcome measures were the results from the radiographs and subjective and clinical evaluation. The response rate was 76% at the follow-up of 14 years; in the chevron group, 37 feet were included compared with 36 feet in the scarf group. Twenty-eight feet in the chevron group and 27 in the scarf group developed recurrence of hallux valgus (P = .483). One patient in the scarf group had a reoperation of the same toe compared with none in the chevron group (P = .314). Current VAS pain scores and results from the SF-36, MOXFQ, and AOFAS did not significantly differ between groups. Both techniques showed similar results after 2 years of follow-up. At 14 years of follow-up, neither technique was superior in preventing recurrence. Level II, randomized controlled trial. © The Author(s) 2016.

  12. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design.

    Science.gov (United States)

    Denost, Quentin; Saillour, Florence; Masya, Lindy; Martinaud, Helene Maillou; Guillon, Stephanie; Kret, Marion; Rullier, Eric; Quintard, Bruno; Solomon, Michael

    2016-04-04

    Among patients with rectal cancer, 5-10% have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10% recur locally following primary surgery (LRRC). In both cases, patients 'care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients' care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients. The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end points will

  13. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design

    International Nuclear Information System (INIS)

    Denost, Quentin; Saillour, Florence; Masya, Lindy; Martinaud, Helene Maillou; Guillon, Stephanie; Kret, Marion; Rullier, Eric; Quintard, Bruno; Solomon, Michael

    2016-01-01

    Among patients with rectal cancer, 5–10 % have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10 % recur locally following primary surgery (LRRC). In both cases, patients ‘care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients’ care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients. The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end

  14. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial.

    Science.gov (United States)

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

    2014-09-01

    To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Randomized controlled, comparative efficacy trial. Los Angeles community. 123 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07-0.97] P insomnia was associated with lower levels of CRP (P insomnia remission. PSG measures did not change. Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. © 2014 Associated Professional Sleep Societies, LLC.

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

    Science.gov (United States)

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

    2010-01-01

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

  16. A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

    Directory of Open Access Journals (Sweden)

    Tamara J. Somers

    2016-01-01

    Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

  17. Applying technology to the treatment of cannabis use disorder: comparing telephone versus Internet delivery using data from two completed trials.

    Science.gov (United States)

    Rooke, Sally E; Gates, Peter J; Norberg, Melissa M; Copeland, Jan

    2014-01-01

    Technology-based interventions such as those delivered by telephone or online may assist in removing significant barriers to treatment seeking for cannabis use disorder. Little research, however, has addressed differing technology-based treatments regarding their comparative effectiveness, and how user profiles may affect compliance and treatment satisfaction. This study addressed this issue by examining these factors in online (N=225) versus telephone (N=160) delivered interventions for cannabis use, using data obtained from two previously published randomized controlled trials conducted by the current authors. Several differences emerged including stronger treatment effects (medium to large effect sizes in the telephone study versus small effect sizes in the Web study) and lower dropout in the telephone intervention (38% vs. 46%). Additionally, around half of the telephone study participants sought concurrent treatment, compared with 2% of participants in the Web study. Demographics and predictors of treatment engagement, retention and satisfaction also varied between the studies. Findings indicate that both telephone and Web-based treatments can be effective in assisting cannabis users to quit or reduce their use; however, participant characteristics may have important implications for treatment preference and outcome, with those who elect telephone-based treatment experiencing stronger outcomes. Thus, participant preference may shape study populations, adherence, and outcome. © 2013 Elsevier Inc. All rights reserved.

  18. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms.

    Science.gov (United States)

    El-Nahas, Ahmed R; Tharwat, Mohamed; Elsaadany, Mohamed; Mosbah, Ahmed; Gaballah, Mohamed A

    2016-07-01

    To compare the effectiveness of tamsulosin and solifenacin in relieving ureteral stents related symptoms. A randomized controlled trial was conducted between January 2013 and July 2014. Inclusion criteria were patients aged 20-50 years who underwent temporary unilateral ureteral stent for drainage of calcular upper tract obstruction or after ureteroscopic lithotripsy. Patients with history of lower urinary tract symptoms before stent placement, stents that were fixed after open or laparoscopic procedures, and those who developed complications related to the primary procedure were not included. Eligible patients were randomly assigned to 1 of 3 groups using computer-generated random tables. Patients in group 1 received placebo, patients in group 2 received tamsulosin 0.4 mg once daily, and those in group 3 received solifenacin 5 mg once daily. Ureteral Stent Symptom Questionnaire (USSQ) was answered by all patients 1-2 weeks after stent placement. The primary outcome was the comparison of total score of USSQ between all groups. The study included 131 patients. All baseline characteristics (age, sex, side, indication, length, and duration of stent) were comparable for all groups. Total USSQ score was 61 in solifenacin group, 76 in tamsulosin group, and 83 in control group (P tamsulosin group (P tamsulosin alone or solifenacin alone in patients with ureteral stents can improve the quality of life by decreasing ureteral stent-related symptoms. Solifenacin was better than tamsulosin. CLINICALTRIAL. NCT01880619.

  19. Comparing Efficacy and Costs of Four Facial Fillers in Human Immunodeficiency Virus-Associated Lipodystrophy: A Clinical Trial.

    Science.gov (United States)

    Vallejo, Alfonso; Garcia-Ruano, Angela A; Pinilla, Carmen; Castellano, Michele; Deleyto, Esther; Perez-Cano, Rosa

    2018-03-01

    The objective of this study was to evaluate and compare the safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to human immunodeficiency virus. The authors conducted a clinical trial including 147 patients suffering from human immunodeficiency virus-induced lipoatrophy treated with Sculptra (poly-L-lactic acid), Radiesse (calcium hydroxylapatite), Aquamid (polyacrylamide), or autologous fat. Objective and subjective changes were evaluated during a 24-month follow-up. Number of sessions, total volume injected, and overall costs of treatment were also analyzed. A comparative cost-effectiveness analysis of the treatment options was performed. Objective improvement in facial lipoatrophy, assessed by the surgeon in terms of changes from baseline using the published classification of Fontdevila, was reported in 53 percent of the cases. Patient self-evaluation showed a general improvement after the use of facial fillers. Patients reported being satisfied with the treatment and with the reduced impact of lipodystrophy on their quality of life. Despite the nonsignificant differences observed in the number of sessions and volume, autologous fat showed significantly lower costs than all synthetic fillers (p < 0.05). Surgical treatment of human immunodeficiency virus-associated facial lipoatrophy using dermal fillers is a safe and effective procedure that improves the aesthetic appearance and the quality of life of patients. Permanent fillers and autologous fat achieve the most consistent results over time, with lipofilling being the most cost-effective procedure.

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

    Science.gov (United States)

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

    2017-03-01

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

  1. Effect of omeprazole and sucralfate on prepyloric gastric ulcer. A double blind comparative trial and one year follow up.

    Science.gov (United States)

    Sørensen, H T; Rasmussen, H H; Balslev, I; Boesby, S; Boné, J; Kruse, A; Rasmussen, S N

    1994-01-01

    This study compared healing rates, relief of symptoms, frequency of adverse events, and proportion of patients in remission after one year follow up in 104 patients with active prepyloric ulcer during treatment with 40 mg omeprazole once daily or 2 g sucralfate twice daily, using a randomised double blind controlled trial. Healing rates after two, four, and six weeks were (omeprazole/sucralfate) 49%/23%; 83%/59%; 90%/70% respectively. After two weeks, omeprazole was more efficient than sucralfate in relief of daytime and nocturnal epigastric pain, nausea, and heartburn. The proportion of patients in remission after one year follow up was significantly higher in the omeprazole group (p < 0.01). Of the healed patients ulcers recurred in 36% in the omeprazole group and in 46% in the sucralfate group. It is concluded that the ulcer healing rate was higher and symptom relief was more pronounced in the omeprazole group compared with the sucralfate group, and that more patients were still in remission after a one year follow up period. PMID:8020815

  2. Influenza detection and prediction algorithms: comparative accuracy trial in Östergötland county, Sweden, 2008-2012.

    Science.gov (United States)

    Spreco, A; Eriksson, O; Dahlström, Ö; Timpka, T

    2017-07-01

    Methods for the detection of influenza epidemics and prediction of their progress have seldom been comparatively evaluated using prospective designs. This study aimed to perform a prospective comparative trial of algorithms for the detection and prediction of increased local influenza activity. Data on clinical influenza diagnoses recorded by physicians and syndromic data from a telenursing service were used. Five detection and three prediction algorithms previously evaluated in public health settings were calibrated and then evaluated over 3 years. When applied on diagnostic data, only detection using the Serfling regression method and prediction using the non-adaptive log-linear regression method showed acceptable performances during winter influenza seasons. For the syndromic data, none of the detection algorithms displayed a satisfactory performance, while non-adaptive log-linear regression was the best performing prediction method. We conclude that evidence was found for that available algorithms for influenza detection and prediction display satisfactory performance when applied on local diagnostic data during winter influenza seasons. When applied on local syndromic data, the evaluated algorithms did not display consistent performance. Further evaluations and research on combination of methods of these types in public health information infrastructures for 'nowcasting' (integrated detection and prediction) of influenza activity are warranted.

  3. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  4. Ten-year experience of superior gluteal artery perforator flap for reconstruction of sacral defects in Tri-Service General Hospital

    Directory of Open Access Journals (Sweden)

    Chin-Ta Lin

    2014-01-01

    Full Text Available Background: Despite advances in reconstruction techniques, sacral sores continue to present a challenge to the plastic surgeon. The superior gluteal artery perforator (SGAP flap is a reliable flap that preserves the entire contralateral side as a future donor site. On the ipsilateral side, the gluteal muscle itself is preserved and all flaps based on the inferior gluteal artery are still possible. However, the dissection of the perforator is tedious and carries a risk of compromising the perforator vessels. Patients and Methods: During the period between April 2003 and March 2013, 30 patients presented to our section with sacral wounds causing by pressure sores or infected pilonidal cysts. Of a total of 30 patients, 13 were female and 17 were male. Their ages ranged from 22 to 92 years old (mean 79.8 years old. Surgical intervention was performed electively with immediate or delayed reconstruction using a SGAP flap. The characteristics of patients′ age, and sex, and cause of sacral defect, co-morbidities, wound culture, flap size, perforator number, hospital stay, and outcome were reviewed. Results: For all operations, the length of the pedicle dissection will not exceed 1 cm because of the vascular anatomy of the SGAP, which lies adjacent to the sacral region. Due to short pedicle dissection, all SGAP flap were elevated around an hour. All flaps survived except two, which had partial flap necrosis and were finally treated by contralateral V-Y advancement flaps coverage. The mean follow-up period was 14.8 months (range 3-24. No flap surgery-related mortality was found. Conclusion: Perforator-based flaps have become popular in modern reconstructive surgery because of low donor site morbidity and good preservation of muscle. Our study shows that deep pedicle dissection is unnecessary when the surgery involves an accurate indicating perforator, adequate flap size design, and correct selection of flap utilization between tunnel and rotation. The

  5. Clinical efficacy and tolerability of praziquantel for intestinal and urinary schistosomiasis-a meta-analysis of comparative and non-comparative clinical trials.

    Directory of Open Access Journals (Sweden)

    Julien Zwang

    Full Text Available Extensive use of praziquantel for treatment and control of schistosomiasis requires a comprehensive understanding of efficacy and safety of various doses for different Schistosoma species.A systematic review and meta-analysis of comparative and non-comparative trials of praziquantel at any dose for any Schistosoma species assessed within two months post-treatment. Of 273 studies identified, 55 were eligible (19,499 subjects treated with praziquantel, control treatment or placebo. Most studied were in school-aged children (64%, S. mansoni (58%, and the 40 mg/kg dose (56%; 68% of subjects were in Africa. Efficacy was assessed as cure rate (CR, n=17,017 and egg reduction rate (ERR, n=13,007; safety as adverse events (AE incidence. The WHO-recommended dose of praziquantel 40 mg/kg achieved CRs of 94.7% (95%CI 92.2-98.0 for S. japonicum, 77.1% (68.4-85.1 for S. haematobium, 76.7% (95%CI 71.9-81.2 for S. mansoni, and 63.5% (95%CI 48.2-77.0 for mixed S. haematobium/S. mansoni infections. Using a random-effect meta-analysis regression model, a dose-effect for CR was found up to 40 mg/kg for S. mansoni and 30 mg/kg for S. haematobium. The mean ERR was 95% for S. japonicum, 94.1% for S. haematobium, and 86.3% for S. mansoni. No significant relationship between dose and ERR was detected. Tolerability was assessed in 40 studies (12,435 subjects. On average, 56.9% (95%CI 47.4-67.9 of the subjects receiving praziquantel 40 mg/kg experienced an AE. The incidence of AEs ranged from 2.3% for urticaria to 31.1% for abdominal pain.The large number of subjects allows generalizable conclusions despite the inherent limitations of aggregated-data meta-analyses. The choice of praziquantel dose of 40 mg/kg is justified as a reasonable compromise for all species and ages, although in a proportion of sites efficacy may be lower than expected and age effects could not be fully explored.

  6. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial: rationale and design

    Directory of Open Access Journals (Sweden)

    Schuler Gerhard

    2011-02-01

    Full Text Available Abstract Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO, but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age ( Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011. Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

  7. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

    DEFF Research Database (Denmark)

    Krarup, L.H.; Gluud, C.; Truelsen, T.

    2008-01-01

    of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

  8. Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    Background Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. Objective To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. Patients and Method Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time. Results Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021). The maximal loudness of low-frequency (40–300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. Conclusions Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures

  9. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    Directory of Open Access Journals (Sweden)

    Falgun Indravadan Vyas

    2014-01-01

    Full Text Available Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Results: Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05; however, the difference was not clinically significant (<1΀C. The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1 st h (P = 0.04. Highest fall of temperature was noted in the 1 st h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Conclusion: Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  10. A prospective randomized trial comparing the efficacy of Letrozole and Clomiphene citrate in induction of ovulation in polycystic ovarian syndrome

    Directory of Open Access Journals (Sweden)

    Kallol Kumar Roy

    2012-01-01

    Full Text Available Objectives: To compare the efficacy of letrozole and clomiphene citrate (CC in patients of anovulatory polycystic ovarian syndrome (PCOS with infertility. Materials and Methods: This prospective randomized clinical trial included 204 patients of PCOS. 98 patients (294 cycles received 2.5-5 mg of letrozole; 106 patients (318 cycles received 50-100 mg of CC (both orally from Days 3-7 of menstrual cycle. The treatment continued for three cycles in both the groups. Main outcome measures: ovulation rate, endometrial thickness, and pregnancy rate. Statistical analysis was done using SPSS 13 software. P value less than 0.05 was considered significant. Results: The mean number of dominant follicles in letrozole groups and CC groups was 1.86±0.26 and 1.92±0.17, respectively (P=0.126. Number of ovulatory cycle in letrozole group was 196 (66.6% versus 216 (67.9% in CC group (P=0.712. The mean mid-cycle endometrial thickness was 9.1±0.3 mm in letrozole group and 6.3±1.1 in CC group, which was statistically significant (P=0.014. The mean Estradiol [E2] level in clomiphene citrate group was significantly higher in CC group (364.2±71.4 pg/mL than letrozole group (248.2± 42.2 pg/mL. 43 patients from the letrozole group (43.8% and 28 patients from the CC group (26.4% became pregnant. Conclusion: Letrozole and CC have comparable ovulation rate. The effect of letrozole showed a better endometrial response and pregnancy rate compared with CC.

  11. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial.

    Science.gov (United States)

    Carter, S; Clifton, P M; Keogh, J B

    2016-12-01

    Weight loss improves glycaemic control in type 2 diabetes mellitus (T2DM). However, as achieving and maintaining weight loss is difficult, alternative strategies are needed. Our primary aim was to investigate the effects of intermittent energy restriction (IER) compared to continuous energy restriction (CER) on glycated haemoglobin A1c (HbA1c). Secondary aims were to assess effects on weight loss, body composition, medication changes and subjective measures of appetite. Using a 2-day IER method, we expected equal improvements to HbA1c and weight in both groups. Sixty-three overweight or obese participants (BMI 35.2±5kg/m 2 ) with T2DM (HbA1c 7.4±1.3%) (57mmol/mol) were randomised to a 2-day severe energy restriction (1670-2500kJ/day) with 5days of habitual eating, compared to a moderate CER diet (5000-6500kJ/day) for 12weeks. At 12weeks HbA1c (-0.7±0.9% P<0.001) and percent body weight reduction (-5.9±4% P<0.001) was similar in both groups with no group by time interaction. Similar reductions were also seen for medication dosages, all measures of body composition and subjective reports of appetite. In this pilot trial, 2days of IER compared with CER resulted in similar improvements in glycaemic control and weight reduction offering a suitable alternative treatment strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    International Nuclear Information System (INIS)

    Babaei Jandaghi, Ali; Lebady, Mohammadkazem; Zamani, Athar-Alsadat; Heidarzadeh, Abtin; Monfared, Ali; Pourghorban, Ramin

    2017-01-01

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  13. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    Energy Technology Data Exchange (ETDEWEB)

    Babaei Jandaghi, Ali [Guilan University of Medical Sciences, Department of Radiology, Poursina Hospital (Iran, Islamic Republic of); Lebady, Mohammadkazem; Zamani, Athar-Alsadat [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Heidarzadeh, Abtin [Guilan University of Medical Sciences, Department of Community Medicine (Iran, Islamic Republic of); Monfared, Ali [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Pourghorban, Ramin, E-mail: ramin-p2005@yahoo.com [Tehran University of Medical Sciences, Department of Radiology, Imam Khomeini Hospital Complex (Iran, Islamic Republic of)

    2017-01-15

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  14. Comparing energy sources for surgical ablation of atrial fibrillation: a Bayesian network meta-analysis of randomized, controlled trials.

    Science.gov (United States)

    Phan, Kevin; Xie, Ashleigh; Kumar, Narendra; Wong, Sophia; Medi, Caroline; La Meir, Mark; Yan, Tristan D

    2015-08-01

    Simplified maze procedures involving radiofrequency, cryoenergy and microwave energy sources have been increasingly utilized for surgical treatment of atrial fibrillation as an alternative to the traditional cut-and-sew approach. In the absence of direct comparisons, a Bayesian network meta-analysis is another alternative to assess the relative effect of different treatments, using indirect evidence. A Bayesian meta-analysis of indirect evidence was performed using 16 published randomized trials identified from 6 databases. Rank probability analysis was used to rank each intervention in terms of their probability of having the best outcome. Sinus rhythm prevalence beyond the 12-month follow-up was similar between the cut-and-sew, microwave and radiofrequency approaches, which were all ranked better than cryoablation (respectively, 39, 36, and 25 vs 1%). The cut-and-sew maze was ranked worst in terms of mortality outcomes compared with microwave, radiofrequency and cryoenergy (2 vs 19, 34, and 24%, respectively). The cut-and-sew maze procedure was associated with significantly lower stroke rates compared with microwave ablation [odds ratio <0.01; 95% confidence interval 0.00, 0.82], and ranked the best in terms of pacemaker requirements compared with microwave, radiofrequency and cryoenergy (81 vs 14, and 1, <0.01% respectively). Bayesian rank probability analysis shows that the cut-and-sew approach is associated with the best outcomes in terms of sinus rhythm prevalence and stroke outcomes, and remains the gold standard approach for AF treatment. Given the limitations of indirect comparison analysis, these results should be viewed with caution and not over-interpreted. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  15. Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O.

    Science.gov (United States)

    Meschia, Michele; Bertozzi, Rosanna; Pifarotti, Paola; Baccichet, Roberto; Bernasconi, Francesco; Guercio, Elso; Magatti, Fabio; Minini, Gianfranco

    2007-11-01

    The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.

  16. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial.

    Science.gov (United States)

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-11-01

    Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research.

  17. Comparative Effects of Different Balance-Training-Progression Styles on Postural Control and Ankle Force Production: A Randomized Controlled Trial.

    Science.gov (United States)

    Cuğ, Mutlu; Duncan, Ashley; Wikstrom, Erik

    2016-02-01

    Despite the effectiveness of balance training, the exact parameters needed to maximize the benefits of such programs remain unknown. One such factor is how individuals should progress to higher levels of task difficulty within a balance-training program. Yet no investigators have directly compared different balance-training-progression styles. To compare an error-based progression (ie, advance when proficient at a task) with a repetition-based progression (ie, advance after a set amount of repetitions) style during a balance-training program in healthy individuals. Randomized controlled trial. Research laboratory. A total of 28 (16 women, 12 men) physically healthy young adults (age = 21.57 ± 3.95 years, height = 171.60 ± 11.03 cm, weight = 72.96 ± 16.18 kg, body mass index = 24.53 ± 3.7). All participants completed 12 supervised balance-training sessions over 4 weeks. Each session consisted of a combination of dynamic unstable-surface tasks that incorporated a BOSU ball and lasted about 30 minutes. Static balance from an instrumented force plate, dynamic balance as measured via the Star Excursion Balance Test, and ankle force production in all 4 cardinal planes of motion as measured with a handheld dynamometer before and after the intervention. Selected static postural-control outcomes, dynamic postural control, and ankle force production in all planes of motion improved (P .05) for any of the outcome measures. A 4-week balance-training program consisting of dynamic unstable-surface exercises on a BOSU ball improved dynamic postural control and ankle force production in healthy young adults. These results suggest that an error-based balance-training program is comparable with but not superior to a repetition-based balance-training program in improving postural control and ankle force production in healthy young adults.

  18. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study.

    Science.gov (United States)

    Montaner, J S; Reiss, P; Cooper, D; Vella, S; Harris, M; Conway, B; Wainberg, M A; Smith, D; Robinson, P; Hall, D; Myers, M; Lange, J M

    1998-03-25

    Current guidelines recommend that individuals infected with the human immunodeficiency virus type 1 (HIV-1) be treated using combinations of antiretroviral agents to achieve sustained suppression of viral replication as measured by the plasma HIV-1 RNA assay, in the hopes of achieving prolonged remission of the disease. However, until recently, many drug combinations have not led to sustained suppression of HIV-1 RNA. To compare the virologic effects of various combinations of nevirapine, didanosine, and zidovudine. Double-blind, controlled, randomized trial. University-affiliated ambulatory research clinics in Italy, the Netherlands, Canada and Australia (INCAS). Antiretroviral therapy-naive adults free of the acquired immunodeficiency syndrome with CD4 cell counts between 0.20 and 0.60x10(9)/L (200-600/microL). Patients received zidovudine plus nevirapine (plus didanosine placebo), zidovudine plus didanosine (plus nevirapine placebo), or zidovudine plus didanosine plus nevirapine. Plasma HIV-1 RNA. Of the 153 enrolled patients, 151 were evaluable. At week 8, plasma HIV-1 RNA levels had decreased by log 2.18, 1.55, and 0.90 in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.05). The proportions of patients with plasma HIV-1 RNA levels below 20 copies per milliliter at week 52 were 51%, 12%, and 0% in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.001). Viral amplification was attempted in 59 patients at 6 months. Viral isolation was unsuccessful in 19 (79%) of 24, 10 (53%) of 19, and 5 (31%) of 16 patients in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively. Among patients from whom virus could be amplified, resistance to nevirapine was found in all 11 patients receiving zidovudine plus nevirapine and in all 5 patients receiving triple drug therapy. Rates of disease progression or death

  19. Clinical Trials

    Medline Plus

    Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

  20. A Randomized Controlled Trial Comparing Behavioral, Educational, and Pharmacological Treatments in Youths With Chronic Tic Disorder or Tourette Syndrome.

    Science.gov (United States)

    Rizzo, Renata; Pellico, Alessandra; Silvestri, Paola Rosaria; Chiarotti, Flavia; Cardona, Francesco

    2018-01-01

    The existing literature on the treatment of pediatric chronic tic disorder (CTD) and Tourette syndrome (TS) indicates that both behavioral therapy (BT) and pharmacotherapy (PT) are effective for reducing symptoms. To evaluate the efficacy of BT compared to psychoeducation (PE) or PT for reducing tics and co-occurring symptoms and for improving quality of life (QoL) in a sample of youths with CTD and TS. A 10 weeks, 2 sites (Catania, Rome) randomized controlled trial. Participants were randomized to receive one of the following treatments: BT, PE, or PT. 110 outpatients aged between 8 and 17 years affected by CTD or TS. Patients in the BT and PT groups showed a significant reduction in the severity of tic symptoms, while the PE group did not show any improvement. PT was more effective for reducing obsessive compulsive symptoms than BT, while PE group did not show any improvement. Both BT and PT groups showed an improvement in most QoL domains, whereas no differences were found in the PE group. BT is as effective as pharmacological therapy in the treatment of tic disorders in children and adolescents, thus offering an alternative to medications for CTD and TS.

  1. How does routinely delivered cognitive-behavioural therapy for gambling disorder compare to "gold standard" clinical trial?

    Science.gov (United States)

    Smith, David P; Fairweather-Schmidt, A Kate; Harvey, Peter W; Battersby, Malcolm W

    2018-03-01

    Currently, it is unknown whether treatment outcomes derived from randomized controlled trials (RCTs) of cognitive-behavioural therapy (CBT) for problem gamblers still hold when applied to patients seen in routine practice. Thus, data from an RCT of cognitive therapy versus exposure therapy for problem gambling versus patients of a gambling help service were compared. Assessments of problem gambling severity, psychosocial impairment, and alcohol use were undertaken at baseline and post-treatment and evaluated within a counterfactual framework. Findings showed that the contrast between routine CBT for pokies and horse betting had a significant effect, indicative of a 62% lower gambling urge score if routine CBT recipients had all been horse/track betters opposed to gambling with "pokies." However, the majority of contrasts indicated therapeutic outcomes achieved in routine CBT treatments were of equivalent robustness relative to RCT conditions. The present findings infer routine practice treatment outcomes are as efficacious as those generated in RCT contexts. Copyright © 2017 John Wiley & Sons, Ltd.

  2. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation

    International Nuclear Information System (INIS)

    Fisher, B.; Redmond, C.; Fisher, E.R.

    1985-01-01

    In 1971 a randomized trial was begun to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative auxillary nodes, with respect to disease-free survival, distant-disease-free survival, or overall survival (about 57%) at 10 years. The patients were treated by radical mastectomy, total (simple) mastectomy without auxillary dissection but with regional irradiation, or total mastectomy without irradiation plus auxillary dissection only if nodes were subsequently positive. Similarly, no differences, were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without auxillary dissection but with regional irradiation. Survival at 10 years was about 38% in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. It was concluded that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer. 25 references, 6 figures, 1 table

  3. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial.

    Science.gov (United States)

    van den Bergh, B; Blankestijn, J; van der Ploeg, T; Tuinzing, D B; Forouzanfar, T

    2015-06-01

    A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of IMFS with the use of arch bars in the treatment of mandibular condyle fractures. The study population consisted of 50 patients (mean age: 31.8 years). Twenty-four (48%) patients were allocated in the IMFS group. Twenty-six (52%) patients were assigned to the arch bars group. In total 188 IMF-screws were used (5-12 screws per patient, mean 7.83 screws per patient). All pain scores were lower in the IMFS group. Three patients developed a malocclusion (IFMS-group: one patient, arch bars-group: two patients). Mean surgical time was significantly shorter in the IMFS group (59 vs. 126 min; pfractured on insertion (0.53%), one (0.53%) screw was inserted into a root. Six (3.2%) screws loosened spontaneously in four patients. Mucosal disturbances were seen in 22 patients, equally divided over both groups. Considering the advantages and the disadvantages of IMFS, and observing the results of this study, the authors conclude that IMFS provide a superior method for IMF. IMFS are safer for the patients and surgeons. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  4. A Randomized Controlled Trial Comparing Behavioral, Educational, and Pharmacological Treatments in Youths With Chronic Tic Disorder or Tourette Syndrome

    Directory of Open Access Journals (Sweden)

    Renata Rizzo

    2018-03-01

    Full Text Available ContextThe existing literature on the treatment of pediatric chronic tic disorder (CTD and Tourette syndrome (TS indicates that both behavioral therapy (BT and pharmacotherapy (PT are effective for reducing symptoms.ObjectiveTo evaluate the efficacy of BT compared to psychoeducation (PE or PT for reducing tics and co-occurring symptoms and for improving quality of life (QoL in a sample of youths with CTD and TS.DesignA 10 weeks, 2 sites (Catania, Rome randomized controlled trial. Participants were randomized to receive one of the following treatments: BT, PE, or PT.Participants110 outpatients aged between 8 and 17 years affected by CTD or TS.ResultsPatients in the BT and PT groups showed a significant reduction in the severity of tic symptoms, while the PE group did not show any improvement. PT was more effective for reducing obsessive compulsive symptoms than BT, while PE group did not show any improvement. Both BT and PT groups showed an improvement in most QoL domains, whereas no differences were found in the PE group.ConclusionsBT is as effective as pharmacological therapy in the treatment of tic disorders in children and adolescents, thus offering an alternative to medications for CTD and TS.

  5. Trial of labor compared to repeat cesarean section in women with no other risk factors than a prior cesarean delivery

    DEFF Research Database (Denmark)

    Studsgaard, Anne; Skorstengaard, Malene; Glavind, Julie

    2013-01-01

    OBJECTIVE: To compare outcomes with trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery on maternal request (ERCD-MR). DESIGN: Prospective cohort study. SETTING: Danish university hospital. POPULATION: Women with TOLAC (n = 1161) and women with ERCD-MR (n = 622) between 2003...... registration of the deliveries. MAIN OUTCOME MEASURES: Adverse neonatal outcomes, risk factors for emergency cesarean, and uterine rupture in case of TOLAC. RESULTS: TOLAC was associated with an increased risk of neonatal depression [odds ratio (OR) 3.6, 95% confidence interval (CI) 1.1-19.1] and neonatal...... vaginal delivery (adjusted OR 1.8, 95% CI 1.1-3.0), index emergency cesarean during labor (adjusted OR 3.0, 95% CI 2.3-4.1), maternal age ≥35 years (adjusted OR 1.9, 95% CI 1.3-2.8), pre-pregnancy body mass index ≥30 (adjusted OR 2.1, 95% CI 1.3-3.3), and birthweight 4000-4499 g (adjusted OR 1.5, 95% CI 1...

  6. Enhancement of exposure therapy in participants with specific phobia: A randomized controlled trial comparing yohimbine, propranolol and placebo.

    Science.gov (United States)

    Meyerbröker, K; Morina, N; Emmelkamp, P M G

    2018-05-04

    Recent research indicates that pharmacological agents may enhance psychotherapeutic outcome. Yet, empirical results have not been conclusive with respect to two pharmacological agents, yohimbine hydrochloride (YOH) and propranolol. YOH is suggested to enhance emotional memory by elevating norepinephrine, whereas the β-adrenergic receptor antagonist propranolol might help better cope with feared situations by reducing accompanying bodily sensations. In this controlled trial, fifty-six participants with specific phobia were randomly assigned to either 1) virtual reality exposure therapy (VRET) plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions received three sessions of VRET over a period of two weeks. We conducted 2 × 3 repeated measures MANOVA's. Results showed a significant effect for time, with partial eta squared ranging from ηp2 = 0.647 to ηp2 = 0.692, for specific phobia, yet no significant interaction effects were found. No significant differences were found when VRET with YOH or a beta-blocker was compared to VRET with a non-active placebo. Implications for clinical practice and future research are discussed. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Failure Rates of Orthodontic Fixed Lingual Retainers bonded with Two Flowable Light-cured Adhesives: A Comparative Prospective Clinical Trial.

    Science.gov (United States)

    Talic, Nabeel F

    2016-08-01

    This comparative prospective randomized clinical trial examined the in vivo failure rates of fixed mandibular and maxillary lingual retainers bonded with two light-cured flowable composites over 6 months. Consecutive patients were divided into two groups on a 1:1 basis. Two hundred fixed lingual retainers were included, and their failures were followed for 6 months. One group (n = 50) received retainers bonded with a nano-hybrid composite based on nano-optimized technology (Tetric-N-Flow, Ivoclar Vivadent). Another group (n = 50) received retainers bonded with a low viscosity (LV) composite (Transbond Supreme LV, 3M Unitek). There was no significant difference between the overall failure rates of mandibular retainers bonded with Transbond (8%) and those bonded with Tetric-N-Flow (18%). However, the odds ratio for failure using Tetric-N-flow was 2.52-fold greater than that of Transbond. The failure rate of maxillary retainers bonded with Transbond was higher (14%), but not significantly different, than that of maxillary retainers bonded with Tetric-N-flow (10%). There was no significant difference in the estimated mean survival times of the maxillary and mandibular retainers bonded with the two composites. Both types of composites tested in the current study can be used to bond fixed maxillary and mandibular lingual retainers, with low failure rates.

  8. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol The comparative rehydration in bronchiolitis study (CRIB

    Directory of Open Access Journals (Sweden)

    Borland Meredith

    2010-06-01

    Full Text Available Abstract Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV or nasogastric (NG. The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR offers benefits over intravenous rehydration (IVR using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV or nasogastric (NG rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640

  9. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

    Science.gov (United States)

    2010-01-01

    Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

  10. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

    Science.gov (United States)

    Boeke, A J; Dekker, J H; van Eijk, J T; Kostense, P J; Bezemer, P D

    1993-01-01

    OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication. PMID:8244360

  11. Interpreting the improved outcome of patients with central nervous system metastases managed in clinical trials compared with standard hospital practice

    International Nuclear Information System (INIS)

    Tang, J.I; Back, M.; Shakespeare, T.; Lu, J.J.; Mukherjee, R.; Wynne, C.

    2005-01-01

    The aims were to determine the median survival and prognostic factors of patients with central nervous system (CNS) metastases managed with whole-brain radiation therapy (WBRT), and to explore selection criteria in recently published clinical trials using aggressive interventions in CNS metastases. A retrospective audit was performed on patients managed with WBRT for CNS metastases. Potential prognostic factors were recorded and analysed for their association with survival duration. The proportion of patients with these factors was also compared with those of patients managed under three recently reported studies investigating aggressive interventions, such as radiosurgery and chemotherapy for CNS metastases. Seventy-three patients were treated with WBRT for cerebral metastases over a 12-month period. The median survival of the population was 3.4 months (95% confidence interval: 2.7-4.1), with 6- and 12-month survival rates of 30 and 18%, respectively. Significant prognostic factors for prolonged median survival were Eastern Cooperative Oncology Group status 0-2 (P = 0.015), Medical Research Council neurological functional status 0-1 (P = 0.006), and Recursive Partitioning Analysis Class 2 versus Class 3 (P = 0.020). On multivariate analysis, younger patient age (P = 0.02) and better performance status (P<0.01) were associated with improved outcome. When comparing these characteristics with selected published studies, our study cohort demonstrated a higher proportion of patients with poor performance status, a greater number of metastases per patient and a higher incidence of extracranial disease. This reflects the selected nature of patients in these published studies. Central nervous system metastases confer a poor prognosis and, for the majority of patients, aggressive interventions are unlikely to improve survival. The use of potentially toxic and expensive treatments should be reserved for those few in whom these studies have shown a potential benefit

  12. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  13. Bacterial endogenous endophthalmitis in Vietnam: a randomized controlled trial comparing vitrectomy with silicone oil versus vitrectomy alone

    Directory of Open Access Journals (Sweden)

    Do T

    2014-08-01

    Full Text Available Tan Do,1 Do N Hon,1 Tin Aung,2 Nguyen DTN Hien,1 Claude L Cowan Jr3 1Vietnam National Institute of Ophthalmology, Hanoi, Vietnam; 2Singapore National Eye Center, Singapore; 3Georgetown University Medical Center, Washington, DC, USA Background/aims: To compare treatment outcomes with and without silicone oil tamponade in patients undergoing pars plana vitrectomy (PPV for severe endogenous bacterial endophthalmitis (BEE. Methods: One hundred and eight consecutive patients with severe BEE (defined by the absence of pupil red reflex at presentation and/or dense vitreous opacity on ultrasound and no improvement after 24–36 hours of medical treatment were randomly assigned to two treatment groups: Group 1, standard PPV with intravitreal antibiotics; and Group 2, PPV with intravitreal antibiotics and silicone tamponade. Overall success was defined as: a visual acuity ≥ count fingers at 1 meter, with an attached retina, and no intraocular oil. Results: Fifty three patients were randomized to Group 1 and 55 patients to Group 2. The mean age of study subjects was 32 years and baseline clinical characteristics were similar in both groups. At the final follow-up visit at 9 months, the overall success rate of Group 2 (67.3% was significantly better than Group 1 (43.4%; P=0.01. There were also fewer devastating complications (such as inoperable retinal detachment, phthisis bulbi in Group 2 compared with Group 1 (21.8% versus 43.4%; P=0.01. Conclusion: The outcome at 9 months of patients with BEE treated by vitrectomy with silicone oil was better than those treated by vitrectomy alone. Keywords: bacterial endogenous endophthalmitis, vitrectomy, silicone oil endotamponade, randomized controlled trial

  14. Comparative trial of Aloe vera/olive oil combination cream versus phenytoin cream in the treatment of chronic wounds.

    Science.gov (United States)

    Panahi, Y; Izadi, M; Sayyadi, N; Rezaee, R; Jonaidi-Jafari, N; Beiraghdar, F; Zamani, A; Sahebkar, A

    2015-10-01

    Aloe vera is a medicinal plant that has been traditionally used to accelerate wound healing. Olive oil is also a natural product that may contribute to wound healing owing to its antimicrobial and anti-inflammatory effects. The present study aimed to evaluate the effect of an Aloe vera-olive oil (AVO) combination cream on the healing process of chronic wounds. In this randomised, double-blind, comparator-controlled, parallel-group trial, patients with chronic wounds were treated with either AVO cream or phenytoin cream as the standard treatment for a period of 30 days. Wound healing was evaluated using Bates-Jensen assessment tool and the severity of pain was assessed using a visual analogue scale (VAS). After initial assessment, 60 patients with chronic wounds (41 with pressure ulcer, 13 with diabetic wounds and 6 with venous ulcers), were recruited and randomised into 2 groups of 30. After 30 days of treatment, significant improvements in the wound size, depth, and edges; necrotic tissue type and amount; exudate type and amount; colour of wound surroundings; and peripheral tissue oedema score were observed in the AVO cream group (p<0.001). The total score of wound healing showed significant improvement with both AVO (p<0.001) and phenytoin (p<0.01) creams, although AVO was more efficacious (p<0.001). Likewise, although both treatments reduced the initial VAS score, the efficacy of AVO was significantly greater (p<0.001). AVO cream significantly accelerates biological healing of chronic wounds and helps to reduce pain severity with a higher efficacy compared with phenytoin cream.

  15. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  16. Treating Procrastination Using Cognitive Behavior Therapy: A Pragmatic Randomized Controlled Trial Comparing Treatment Delivered via the Internet or in Groups.

    Science.gov (United States)

    Rozental, Alexander; Forsström, David; Lindner, Philip; Nilsson, Simon; Mårtensson, Lina; Rizzo, Angela; Andersson, Gerhard; Carlbring, Per

    2018-03-01

    Procrastination is a common problem among university students, with at least half of the population reporting great difficulties initiating or completing tasks and assignments. Procrastination can have a negative impact on course grades and the ability to achieve a university degree, but can also lead to psychological distress. Cognitive behavior therapy (CBT) is believed to reduce procrastination, but few studies have investigated its effectiveness in a regular clinical setting. The current study explored its effects using a pragmatic randomized controlled trial comparing treatment delivered during 8 weeks as self-guided CBT via the Internet (ICBT) or as group CBT. In total, 92 university students with severe procrastination were included in the study (registered as a clinical trial on Clinicaltrials.gov: NCT02112383). Outcome measures on procrastination, depression, anxiety, and well-being were distributed at pre- and posttreatment as well as 6-month follow-up. An outcome measure of procrastination was administered weekly. Linear mixed and fixed effects models were calculated, along with improvement and deterioration rates. The results showed large within-group effect sizes on procrastination, Cohen's d of 1.29 for ICBT, 95% Confidence Interval (CI) [0.81, 1.74], and d of 1.24 for group CBT, 95% CI [0.76, 1.70], and small to moderate benefits for depression, anxiety, and well-being. In total, 33.7% were regarded as improved at posttreatment and 46.7% at follow-up. No differences between conditions were observed after the treatment period, however, participants in group CBT continued or maintained their improvement at follow-up, while participants in self-guided ICBT showed some signs of deterioration. The findings from the current study suggest that CBT might be an effective treatment for those struggling with severe procrastination, but that a group format may be better for some to sustain their benefits over time and that the clinical significance of the

  17. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    Directory of Open Access Journals (Sweden)

    Duszynski Katherine M

    2011-01-01

    Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

  18. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  19. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    International Nuclear Information System (INIS)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon

    2001-01-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9± 11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly

  20. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

    Science.gov (United States)

    Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

    2014-09-30

    Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

  1. Efficacy and Safety of Sparsentan Compared With Irbesartan in Patients With Primary Focal Segmental Glomerulosclerosis: Randomized, Controlled Trial Design (DUET

    Directory of Open Access Journals (Sweden)

    Radko Komers

    2017-07-01

    Discussion: This study will provide important evidence on whether dual ARB and endothelin blockade may be an effective therapeutic strategy for FSGS and may provide the rationale for next-phase trials.

  2. A non-inferiority randomized controlled clinical trial comparing Unani formulation & psoralen plus ultraviolet A sol in chronic plaque psoriasis.

    Science.gov (United States)

    Khanna, Neena; Nazli, Tamanna; Siddiqui, Khalid Mahmud; Kalaivani, Mani

    2018-01-01

    Though Unani medications have been used for centuries to treat psoriasis, there is paucity of published studies which have systematically evaluated their efficacy and safety. This study was conducted to establish non-inferiority of Unani medications (oral UNIM-401 and topical UNIM-403) vs psoralen plus ultraviolet A (PUVA) sol in treatment of moderate-severe chronic plaque psoriasis (CPP) in achieving psoriasis area severity index (PASI) 75 at 12 wk and to estimate proportion of patients who relapsed in follow up period of 12 weeks, after having achieved PASI 50. In this randomized, controlled trial patients with CPP were block randomized to receive either Unani treatment (147 patients) or PUVA sol (140 patients) for 12 weeks. Percentage reduction in PASI was determined in each patient at 12 wk to calculate number of patients who achieved PASI 75 as also to estimate median of percentage reduction in PASI in each group. All patients who achieved PASI 50 at 12 weeks were followed up for another 12 wk to determine proportion of patients who relapsed. Of the 287 patients randomized, 84 of 147 in Unani group and 67 of 140 in PUVA sol group completed 12 weeks of treatment. On intention-to-treat (ITT) analysis, the response in patients on Unani medication was not inferior to those receiving PUVA sol, in attaining PASI 75 (16.3% in Unani group vs 15.7% in the PUVA sol group). Median of percentage reduction of PASI at 12 wk from baseline in Unani group (68.2%; -60, 100) and PUVA sol group (63%; -15.7, 100) was comparable. Proportion of patients who relapsed at 24 wk was comparable in both groups. However, frequency of clinical side effects was significantly higher (P =0.001) in PUVA sol group (16.4%) compared to Unani group (2%). The findings of the present study indicated that oral UNIM-401 and topical UNIM-403 were effective and well tolerated therapeutic options in patients with moderate-severe CPP.

  3. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.

    Directory of Open Access Journals (Sweden)

    Michael H Chung

    2011-03-01

    Full Text Available Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and

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

    Science.gov (United States)

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

    2015-02-05

    important insights regarding the effects of different modes of exercise on locomotor function in PD. The protocol is innovative because it: 1) uses group exercise approaches for all conditions including treadmill training, 2) directly compares tango to treadmill training and stretching, 3) tests participants OFF medication, and 4) utilizes two distinct neuroimaging approaches to explore mechanisms of the effects of exercise on the brain. ClinicalTrials.gov NCT01768832 .

  5. Comparative Effects of Different Balance-Training–Progression Styles on Postural Control and Ankle Force Production: A Randomized Controlled Trial

    Science.gov (United States)

    Cuğ, Mutlu; Duncan, Ashley; Wikstrom, Erik

    2016-01-01

    Context:  Despite the effectiveness of balance training, the exact parameters needed to maximize the benefits of such programs remain unknown. One such factor is how individuals should progress to higher levels of task difficulty within a balance-training program. Yet no investigators have directly compared different balance-training–progression styles. Objective:  To compare an error-based progression (ie, advance when proficient at a task) with a repetition-based progression (ie, advance after a set amount of repetitions) style during a balance-training program in healthy individuals. Design:  Randomized controlled trial. Setting:  Research laboratory. Patients or Other Participants:  A total of 28 (16 women, 12 men) physically healthy young adults (age = 21.57 ± 3.95 years, height = 171.60 ± 11.03 cm, weight = 72.96 ± 16.18 kg, body mass index = 24.53 ± 3.7). Intervention(s):  All participants completed 12 supervised balance-training sessions over 4 weeks. Each session consisted of a combination of dynamic unstable-surface tasks that incorporated a BOSU ball and lasted about 30 minutes. Main Outcome Measure(s):  Static balance from an instrumented force plate, dynamic balance as measured via the Star Excursion Balance Test, and ankle force production in all 4 cardinal planes of motion as measured with a handheld dynamometer before and after the intervention. Results:  Selected static postural-control outcomes, dynamic postural control, and ankle force production in all planes of motion improved (P .05) for any of the outcome measures. Conclusions:  A 4-week balance-training program consisting of dynamic unstable-surface exercises on a BOSU ball improved dynamic postural control and ankle force production in healthy young adults. These results suggest that an error-based balance-training program is comparable with but not superior to a repetition-based balance-training program in improving postural control and ankle force production in

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

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in

  7. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

    OpenAIRE

    Borland Meredith; Acworth Jason; Babl Franz E; Oakley Ed; Kreiser David; Neutze Jocelyn; Theophilos Theane; Donath Susan; South Mike; Davidson Andrew

    2010-01-01

    Abstract Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the...

  8. "I was a little surprised": Qualitative Insights from Patients Enrolled in a 12-Month Trial Comparing Opioids to Non-Opioid Medications for Chronic Musculoskeletal Pain.

    Science.gov (United States)

    Marianne S Matthias; Donaldson, Melvin T; Jensen, Agnes C; Krebs, Erin E

    2018-04-28

    Chronic musculoskeletal pain is a major public health problem. Although opioid prescribing for chronic pain has increased dramatically since the 1990s, this practice has come under scrutiny because of increases in opioid-related harms and lack of evidence for long-term effectiveness. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic 12-month randomized trial comparing benefits and harms of opioid versus non-opioid medications for chronic musculoskeletal pain. The current qualitative study was designed to better understand trial results by exploring patients' experiences, including perceptions of medications, experiences with the intervention, and whether expectations were met. Thirty-four participants who were purposefully sampled based on treatment group and intervention response participated in semi-structured interviews. The constant comparison method guided analysis. Results revealed that participants often held strong beliefs about opioid medications, which sometimes changed during the trial as they gained experience with medications; participants described a wide variety of experiences with treatment effectiveness, regardless of study group or their response to the intervention; and participants highly valued the personalized pain care model used in SPACE. SPACE trial results indicated no advantage for opioid over non-opioid medications. Qualitative findings suggest that, for patients in both treatment groups, pre-existing expectations of medications and of anticipated improvement in pain shaped experiences with and responses to medications. In addition, the personalized pain care model was described as contributing to positive outcomes in both groups. Copyright © 2018. Published by Elsevier Inc.

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

    Directory of Open Access Journals (Sweden)

    Seyed Hamid Reza Faiz

    2014-01-01

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

  10. The Effect of Oxygen Inhalation Plus Oxytocin Compared with Oxytocin Only on Postpartum Haemorrhage: A Randomized Clinical Trial.

    Science.gov (United States)

    Suhrabi, Zainab; Taghinejad, Hamid; Direkvand-Moghadam, Ashraf; Akbari, Malihe

    2016-09-01

    Post Partum Haemorrhage (PPH) is the leading cause of maternal mortality across the world, mainly in the developing countries. The present study was conducted with the aim to investigate effect of oxygen inhalation plus oxytocin compared with oxytocin only on PPH. This study was a clinical trial which was performed in Shahid Mustafa Khomieni Teaching Hospital of Ilam (western Iran) from April 2012 to Nov 2013. One hundred and twenty pregnant women who were referred to delivery ward for normal vaginal delivery were selected with convenience sampling method and they were randomly assigned into two groups. For both groups management of the third stage of labour was done using 1000CC Ringer and 20 units of Oxytocin. In the intervention group, in addition to the routine administration, 8 liters of oxygen via face mask was used continuously until 2 hours after delivery. Blood loss was determined by regular weighing of the buttocks that were previously weighted. The difference was calculated before and after weighing (1 gram increasing of weight was considered to be equivalent to 1CC blood loss). Data were analysed by SPSS 16 version using Student- t and Chi-square tests. The two groups were homogenous in regard to all the base line variables. The study results indicated that the mean of blood loss were (256.16±97) ml at two hours after delivery in the control group and (149.5±46.49) ml in the intervention group. There was a significant difference between PPH of the two groups (poxytocin infusion during 2hours later resulted in a significant decreasing in the amount of bleeding after normal vaginal delivery.

  11. A randomized clinical trial comparing an acceptance-based behavior therapy to applied relaxation for generalized anxiety disorder.

    Science.gov (United States)

    Hayes-Skelton, Sarah A; Roemer, Lizabeth; Orsillo, Susan M

    2013-10-01

    To examine whether an empirically and theoretically derived treatment combining mindfulness- and acceptance-based strategies with behavioral approaches would improve outcomes in generalized anxiety disorder (GAD) over an empirically supported treatment. This trial randomized 81 individuals (65.4% female, 80.2% identified as White, average age 32.92) diagnosed with GAD to receive 16 sessions of either an acceptance-based behavior therapy (ABBT) or applied relaxation (AR). Assessments at pretreatment, posttreatment, and 6-month follow-up included the following primary outcome measures: GAD clinician severity rating, Structured Interview Guide for the Hamilton Anxiety Rating Scale, Penn State Worry Questionnaire, Depression Anxiety Stress Scale, and the State-Trait Anxiety Inventory. Secondary outcomes included the Beck Depression Inventory-II, Quality of Life Inventory, and number of comorbid diagnoses. Mixed effect regression models showed significant, large effects for time for all primary outcome measures (ds = 1.27 to 1.61) but nonsignificant, small effects for condition and Condition × Time (ds = 0.002 to 0.20), indicating that clients in the 2 treatments improved comparably over treatment. For secondary outcomes, time was significant (ds = 0.74 to 1.38), but condition and Condition × Time effects were not (ds = 0.004 to 0.31). No significant differences emerged over follow-up (ds = 0.03 to 0.39), indicating maintenance of gains. Between 63.3 and 80.0% of clients in ABBT and 60.6 and 78.8% of clients in AR experienced clinically significant change across 5 calculations of change at posttreatment and follow-up. ABBT is a viable alternative for treating GAD. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

  12. A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693

    Directory of Open Access Journals (Sweden)

    Khedmat Hossein

    2004-12-01

    Full Text Available Abstract Background Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD. In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC and simple dressing (SD. Methods Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 ± 6.04 years and 61.12 ± 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening". Results Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19% vs 12/30(40%; difference: 34.19%, 95% CI = 10.85–57.52, (P 0.05]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients. This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4% vs 11/28 (39.3%; difference: 32.1%, 95% CI = 7.4–56.7, (P Conclusion We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.

  13. Effect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial.

    Science.gov (United States)

    Fuller, Louise M; El-Ansary, Doa; Button, Brenda M; Corbett, Monique; Snell, Greg; Marasco, Silvana; Holland, Anne E

    2017-10-16

    To investigate the effect of a supervised upper limb (UL) program (SULP) compared to no supervised UL program (NULP) after lung transplantation (LTx). Randomized controlled trial. Physiotherapy gym. Participants (N=80; mean age, 56±11y; 37 [46%] men) were recruited after LTx. All participants underwent lower limb strength thrice weekly and endurance training. Participants randomized to SULP completed progressive UL strength training program using handheld weights and adjustable pulley equipment. Overall bodily pain was rated on the visual analog scale. Shoulder flexion and abduction muscle strength were measured on a hand held dynamometer. Health related quality of life was measured with Medical Outcomes Study 36-item Short Form health Survey and the Quick Dash. Measurements were made at baseline, 6 weeks, 12 weeks, and 6 months by blinded assessors. After 6 weeks of training, participants in the SULP (n=41) had less overall bodily pain on the visual analog scale than did participants in the NULP (n=36) (mean VAS bodily pain score, 2.1±1.3cm vs 3.8±1.7cm; P<.001) as well as greater UL strength than did participants in the NULP (mean peak force, 8.4±4.0Nm vs 6.7±2.8Nm; P=.037). At 12 weeks, participants in the SULP better quality of life related to bodily pain (76±17 vs 66±26; P=.05), but at 6 months there were no differences between the groups in any outcome measures. No serious adverse events were reported. UL rehabilitation results in short-term improvements in pain and muscle strength after LTx, but no longer-term effects were evident. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  14. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    Science.gov (United States)

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

  15. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy—Adolescent Skills Training to Group Counseling in Schools

    Science.gov (United States)

    Benas, Jessica S.; Schueler, Christie M.; Gallop, Robert; Gillham, Jane E.; Mufson, Laura

    2017-01-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset. PMID:26638219

  16. Virtual Reality Compared with Bench-Top Simulation in the Acquisition of Arthroscopic Skill: A Randomized Controlled Trial.

    Science.gov (United States)

    Banaszek, Daniel; You, Daniel; Chang, Justues; Pickell, Michael; Hesse, Daniel; Hopman, Wilma M; Borschneck, Daniel; Bardana, Davide

    2017-04-05

    Work-hour restrictions as set forth by the Accreditation Council for Graduate Medical Education (ACGME) and other governing bodies have forced training programs to seek out new learning tools to accelerate acquisition of both medical skills and knowledge. As a result, competency-based training has become an important part of residency training. The purpose of this study was to directly compare arthroscopic skill acquisition in both high-fidelity and low-fidelity simulator models and to assess skill transfer from either modality to a cadaveric specimen, simulating intraoperative conditions. Forty surgical novices (pre-clerkship-level medical students) voluntarily participated in this trial. Baseline demographic data, as well as data on arthroscopic knowledge and skill, were collected prior to training. Subjects were randomized to 5-week independent training sessions on a high-fidelity virtual reality arthroscopic simulator or on a bench-top arthroscopic setup, or to an untrained control group. Post-training, subjects were asked to perform a diagnostic arthroscopy on both simulators and in a simulated intraoperative environment on a cadaveric knee. A more difficult surprise task was also incorporated to evaluate skill transfer. Subjects were evaluated using the Global Rating Scale (GRS), the 14-point arthroscopic checklist, and a timer to determine procedural efficiency (time per task). Secondary outcomes focused on objective measures of virtual reality simulator motion analysis. Trainees on both simulators demonstrated a significant improvement (p virtual reality simulation group consistently outperformed the bench-top model group in the diagnostic arthroscopy crossover tests and in the simulated cadaveric setup. Furthermore, the virtual reality group demonstrated superior skill transfer in the surprise skill transfer task. Both high-fidelity and low-fidelity simulation trainings were effective in arthroscopic skill acquisition. High-fidelity virtual reality

  17. Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches.

    Science.gov (United States)

    Vroland-Nordstrand, Kristina; Eliasson, Ann-Christin; Jacobsson, Helén; Johansson, Ulla; Krumlinde-Sundholm, Lena

    2016-06-01

    The efficacy of two different goal-setting approaches (children's self-identified goals and goals identified by parents) were compared on a goal-directed, task-oriented intervention. In this assessor-blinded parallel randomized trial, 34 children with disabilities (13 males, 21 females; mean age 9y, SD 1y 4mo) were randomized using concealed allocation to one of two 8-week, goal-directed, task-oriented intervention groups with different goal-setting approaches: (1) children's self-identified goals (n=18) using the Perceived Efficacy and Goal-Setting System, or (2) goals identified by parents (n=16) using the Canadian Occupational Performance Measure (COPM). Participants were recruited through eight paediatric rehabilitation centres and randomized between October 2011 and May 2013. The primary outcome measure was the Goal Attainment Scaling and the secondary measure, the COPM performance scale (COPM-P). Data were collected pre- and post-intervention and at the 5-month follow-up. There was no evidence of a difference in mean characteristics at baseline between groups. There was evidence of an increase in mean goal attainment (mean T score) in both groups after intervention (child-goal group: estimated mean difference [EMD] 27.84, 95% CI 22.93-32.76; parent-goal group: EMD 21.42, 95% CI 16.16-26.67). There was no evidence of a difference in the mean T scores post-intervention between the two groups (EMD 6.42, 95% CI -0.80 to 13.65). These results were sustained at the 5-month follow-up. Children's self-identified goals are achievable to the same extent as parent-identified goals and remain stable over time. Thus children can be trusted to identify their own goals for intervention, thereby influencing their involvement in their intervention programmes. © 2015 Mac Keith Press.

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

    Directory of Open Access Journals (Sweden)

    Sussan S. Mohammadi

    2015-05-01

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

  19. A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

    Science.gov (United States)

    Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

    2017-07-01

    A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

  20. Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression

    Directory of Open Access Journals (Sweden)

    Jessica Smith

    2017-09-01

    Full Text Available Major Depressive Disorder (MDD is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT included participants meeting diagnostic criteria for MDD (n = 270 being randomised to either: iCBT (n = 61, a CBT self-help book (bCBT (n = 77, a meditation self-help book (bMED (n = 64 or wait-list control (WLC (n = 68. The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9 at 12-weeks (post-treatment. All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88–1.69, which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09–1.04. Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

  1. A longitudinal trial comparing chloroquine as monotherapy or in combination with artesunate, azithromycin or atovaquone-proguanil to treat malaria.

    Directory of Open Access Journals (Sweden)

    Miriam K Laufer

    Full Text Available The predominance of chloroquine-susceptible falciparum malaria in Malawi more than a decade after chloroquine's withdrawal permits contemplation of re-introducing chloroquine for targeted uses. We aimed to compare the ability of different partner drugs to preserve chloroquine efficacy and prevent the re-emergence of resistance.Children with uncomplicated malaria were enrolled at a government health center in Blantyre, Malawi. Participants were randomized to receive chloroquine alone or combined with artesunate, azithromycin or atovaquone-proguanil for all episodes of uncomplicated malaria for one year. The primary outcome was incidence of clinical malaria. Secondary endpoints included treatment efficacy, and incidence of the chloroquine resistance marker pfcrt T76 and of anemia. Of the 640 children enrolled, 628 were included in the intention-to-treat analysis. Malaria incidence (95% confidence interval was 0.59 (.46-.74, .61 (.49-.76, .63 (.50-.79 and .68 (.54-.86 episodes/person-year for group randomized to receive chloroquine alone or in combination with artesunate, azithromycin or atovaquone-proguanil respectively and the differences were not statistically significant. Treatment efficacy for first episodes was 100% for chloroquine monotherapy and 97.9% for subsequent episodes of malaria. Similar results were seen in each of the chloroquine combination groups. The incidence of pfcrt T76 in pure form was 0%; mixed infections with both K76 and T76 were found in two out of 911 infections. Young children treated with chloroquine-azithromycin had higher hemoglobin concentrations at the study's end than did those in the chloroquine monotherapy group.Sustained chloroquine efficacy with repeated treatment supports the eventual re-introduction of chloroquine combinations for targeted uses such as intermittent preventive treatment.ClinicalTrials.gov NCT00379821.

  2. A longitudinal trial comparing chloroquine as monotherapy or in combination with artesunate, azithromycin or atovaquone-proguanil to treat malaria.

    Science.gov (United States)

    Laufer, Miriam K; Thesing, Phillip C; Dzinjalamala, Fraction K; Nyirenda, Osward M; Masonga, Rhoda; Laurens, Matthew B; Stokes-Riner, Abbie; Taylor, Terrie E; Plowe, Christopher V

    2012-01-01

    The predominance of chloroquine-susceptible falciparum malaria in Malawi more than a decade after chloroquine's withdrawal permits contemplation of re-introducing chloroquine for targeted uses. We aimed to compare the ability of different partner drugs to preserve chloroquine efficacy and prevent the re-emergence of resistance. Children with uncomplicated malaria were enrolled at a government health center in Blantyre, Malawi. Participants were randomized to receive chloroquine alone or combined with artesunate, azithromycin or atovaquone-proguanil for all episodes of uncomplicated malaria for one year. The primary outcome was incidence of clinical malaria. Secondary endpoints included treatment efficacy, and incidence of the chloroquine resistance marker pfcrt T76 and of anemia. Of the 640 children enrolled, 628 were included in the intention-to-treat analysis. Malaria incidence (95% confidence interval) was 0.59 (.46-.74), .61 (.49-.76), .63 (.50-.79) and .68 (.54-.86) episodes/person-year for group randomized to receive chloroquine alone or in combination with artesunate, azithromycin or atovaquone-proguanil respectively and the differences were not statistically significant. Treatment efficacy for first episodes was 100% for chloroquine monotherapy and 97.9% for subsequent episodes of malaria. Similar results were seen in each of the chloroquine combination groups. The incidence of pfcrt T76 in pure form was 0%; mixed infections with both K76 and T76 were found in two out of 911 infections. Young children treated with chloroquine-azithromycin had higher hemoglobin concentrations at the study's end than did those in the chloroquine monotherapy group. Sustained chloroquine efficacy with repeated treatment supports the eventual re-introduction of chloroquine combinations for targeted uses such as intermittent preventive treatment. ClinicalTrials.gov NCT00379821.

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

    Science.gov (United States)

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

    2015-11-01

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

  4. A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica

    Directory of Open Access Journals (Sweden)

    Xue Zhang

    2017-01-01

    Full Text Available Objective. To investigate the short- and long-term effects of electroacupuncture (EA compared with medium-frequency electrotherapy (MFE on chronic discogenic sciatica. Methods. One hundred participants were randomized into two groups to receive EA (n=50 or MFE (n=50 for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI, patient global impression (PGI, drug use frequency, and EA acceptance. Results. The mean changes in the average leg pain numerical rating scale (NRS scores were 2.30 (1.86–2.57 and 1.06 (0.62–1.51 in the EA and MFE groups at week 4, respectively. The difference was significant (P<0.001. The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70–2.53 and 0.36 (−0.05–0.78 from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

  5. COMPARATIVE STUDY OF 4 WEEKS OF DYNAMIC B ALANCE TRAINING PROGRAM IN COLLEGIATE FOOTBALL PLAYERS: RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Nisha

    2015-03-01

    Full Text Available BACKGROUND: Balance is highly integrative dynamic process involving coordination of multiple neurological pathways that allows for the maintenance of the COG over BOS . Football players often perform lower extremity passing , shooting , twisting , cutting and dribbling skills while wearing shoes , these actions require body to be in the equilibrium position to perform the task . This leads to t he conclusion of the great importance of the ability of balance in football . AIMS: 1 . To study the effect of 4 week multidirectional balance board training on dynamic balance in football players . 2 . To study the effect of 4 week Both Sides Up ball training on dynamic balance in football players . 3 . To compare the effect of multidirectional balance board training program and BOSU ball training program on dynamic balance in football players . STUDY DESIGN: Randomized Clinical trial . METHODS: Total of 60 competitive badminton players with age group between18 - 25 were recruited in this study . The participants were allocated into 2 groups viz ., Group A (multidirectional balance board training and Group B (BOSU ball Training for a period of 4 we eks . Participants were test for SEBT and vertical jump test on first day and after 4 weeks of balance training . STATISTICAL ANALYSIS: Student t test , Chi - Square Test . RESULTS: The data analysis and statistical inference showed that , after 4 weeks of balanc e training there was improvement in dynamic balance in both the groups but there was no significant difference in dynamic balance between two groups . As seen by difference in the SEBT and VJT scores pre and post training with p<0 . 001 . CONCLUSION: 4 weeks balance training using BOSU and multidirectional balance board is effective in improving dynamic balance and vertical jump performance in football players and also can be used as a component of multifaceted training to improve dynamic balance and game skills

  6. Investigating the heterogeneity of alkylating agents' efficacy and toxicity between sexes: A systematic review and meta-analysis of randomized trials comparing cyclophosphamide and ifosfamide (MAIAGE study)

    NARCIS (Netherlands)

    Fresneau, Brice; Hackshaw, A.; Hawkins, D. S.; Paulussen, M.; Anderson, J. R.; Judson, I.; Litière, S.; Dirksen, U.; Lewis, I.; van den Berg, H.; Gaspar, N.; Gelderblom, H.; Whelan, J.; Boddy, A. V.; Wheatley, K.; Pignon, J. P.; de Vathaire, F.; Le Deley, M. C.; Le Teuff, G.

    2017-01-01

    A marginal interaction between sex and the type of alkylating agent was observed for event-free survival in the Euro-EWING99-R1 randomized controlled trial (RCT) comparing cyclophosphamide and ifosfamide in Ewing sarcoma. To further evaluate this interaction, we performed an individual patient data

  7. Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    NARCIS (Netherlands)

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with

  8. Cancer-related fatigue and rehabilitation: A randomized controlled multicenter trial comparing physical training combined with cognitive-behavioral therapy with physical training only and with no intervention

    NARCIS (Netherlands)

    E. van Weert (Ellen); A.M. May (Anne); I. Korstjens (Irene); W.J. Post (Wendy); C.P. van der Schans (Cees); B. van den Borne (Bart); I. Mesters (Ilse); W.J.G. Ros (Wynand); J.E.H.M. Hoekstra-Weebers (Josette)

    2010-01-01

    textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined

  9. Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care

    NARCIS (Netherlands)

    J.T. van Wyk (Jacobus); M.A.M. van Wijk (Marc); P.W. Moorman (Peter); M. Mosseveld (Mees); J. van der Lei (Johan)

    2003-01-01

    textabstractAutomated and on-demand decision support systems integrated into an electronic medical record have proven to be an effective implementation strategy for guidelines. Cholgate is a randomized controlled trial comparing the effect of automated and on-demand decision

  10. Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

    Science.gov (United States)

    Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

    2016-01-01

    A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

  11. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy

    NARCIS (Netherlands)

    Lacro, R.V.; Guey, L.T.; Dietz, H.C.; Pearson, G.D.; Yetman, A.T.; Gelb, B.D.; Loeys, B.L.; Benson, D.W.; Bradley, T.J.; Backer, J. de; Forbus, G.A.; Klein, G.L.; Lai, W.W.; Levine, J.C.; Lewin, M.B.; Markham, L.W.; Paridon, S.M.; Pierpont, M.E.; Radojewski, E.; Selamet Tierney, E.S.; Sharkey, A.M.; Wechsler, S.B.; Mahony, L.; et al.,

    2013-01-01

    BACKGROUND: The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and

  12. Randomized Trials Comparing Inactivated Vaccine after Medium- or High-titer Measles Vaccine with Standard Titer Measles Vaccine after Inactivated Vaccine

    DEFF Research Database (Denmark)

    Aaby, Peter; Ravn, Henrik; Benn, Christine S.

    2016-01-01

    Background: Observational studies have suggested that girls have higher mortality if their most recent immunization is an inactivated vaccine rather than a live vaccine. We therefore reanalyzed 5 randomized trials of early measles vaccine (MV) in which it was possible to compare an inactivated va...

  13. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

    NARCIS (Netherlands)

    de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

    2011-01-01

    This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

  14. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse : randomised controlled trial in primary care

    NARCIS (Netherlands)

    Wiegersma, Marian; Panman, Chantal M. C. R.; Kollen, Boudewijn J.; Berger, Marjolein Y.; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H.

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women

  15. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder

    NARCIS (Netherlands)

    Landsheer, Johannes A.; Smit, Johannes H.; van Oppen, Patricia; van Balkom, Anton J L M

    2015-01-01

    The effectiveness of Fluvoxamine was compared to that of Cognitive The