Sample records for multiple treatment groups

  1. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

    PubMed Central

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-01-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  2. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

  3. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial.

    PubMed

    Reznik, Yves; Cohen, Ohad; Aronson, Ronnie; Conget, Ignacio; Runzis, Sarah; Castaneda, Javier; Lee, Scott W

    2014-10-04

    Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results. We aimed to resolve this uncertainty with a randomised controlled trial (OpT2mise). We did this multicentre, controlled trial at 36 hospitals, tertiary care centres, and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period. After the run-in period, patients with glycated haemoglobin of 8·0-12·0% (64-108 mmol/mol) were randomly assigned (1:1) by a computer-generated randomisation sequence (block size 2 with probability 0·75 and size 4 with probability 0·25) to pump treatment or to continue with multiple daily injections. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01182493. 495 of 590 screened patients entered the run-in phase and 331 were randomised (168 to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin had decreased by 1·1% (SD 1·2; 12 mmol/mol, SD 13) in the pump treatment group and 0·4% (SD 1·1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting in a between-group treatment difference of -0·7% (95% CI -0·9 to -0·4; -8 mmol/mol, 95% CI -10 to -4, p<0·0001). At the end of the study, the mean total daily insulin dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple daily injections (p<0·0001), with no significant difference in bodyweight change between the two groups (1·5 kg [SD 3·5] vs 1·1 kg [3·6], p=0·322). Two diabetes-related serious adverse events (hyperglycaemia or ketosis without acidosis) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group. No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group. In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin, pump treatment can be considered as a safe and valuable treatment option. Medtronic. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction.

    PubMed

    Coleman, William P; Coleman, William; Weiss, Robert A; Kenkel, Jeffrey M; Ad-El, Dean D; Amir, Ruthie

    2017-01-01

    Demand for nonsurgical esthetic body procedures has led to the development of noninvasive techniques for reducing localized subcutaneous adipose tissue. This study assessed multiple treatments with nonthermal focused ultrasound for noninvasive abdominal treatment of excess fat deposits. Subjects were randomly assigned to Group 1 for a 4-week control phase before undergoing 3 abdominal fat reduction treatments, at 2-week intervals, or to Group 2 for immediate treatment. Weight, abdominal circumference, tolerability to treatment, subject satisfaction, and adverse events were recorded. Weight remained stable in the 126 participants. Mean reduction in midline circumference was 2.5 ± 2.1 cm in the Group 1 and 3.5 ± 2.7 cm in the Group 2 at Week 22. The effect of multiple treatments was cumulative with a steady decrease in abdominal circumferences during the study. Erythema was observed in 28% of treatments but was mild and transient in nature. Subjects tolerated the treatments well and were satisfied with treatment outcome. The study demonstrated the efficacy and safety of multiple nonthermal focused ultrasound treatments of excess abdominal fat deposits. Although the remodeling effect is minor compared with traditional surgical procedures, successive focused ultrasound treatments significantly reduced treatment area circumference, while avoiding invasive techniques and their associated disadvantages.

  5. Should multiple imputation be the method of choice for handling missing data in randomized trials?

    PubMed Central

    Sullivan, Thomas R; White, Ian R; Salter, Amy B; Ryan, Philip; Lee, Katherine J

    2016-01-01

    The use of multiple imputation has increased markedly in recent years, and journal reviewers may expect to see multiple imputation used to handle missing data. However in randomized trials, where treatment group is always observed and independent of baseline covariates, other approaches may be preferable. Using data simulation we evaluated multiple imputation, performed both overall and separately by randomized group, across a range of commonly encountered scenarios. We considered both missing outcome and missing baseline data, with missing outcome data induced under missing at random mechanisms. Provided the analysis model was correctly specified, multiple imputation produced unbiased treatment effect estimates, but alternative unbiased approaches were often more efficient. When the analysis model overlooked an interaction effect involving randomized group, multiple imputation produced biased estimates of the average treatment effect when applied to missing outcome data, unless imputation was performed separately by randomized group. Based on these results, we conclude that multiple imputation should not be seen as the only acceptable way to handle missing data in randomized trials. In settings where multiple imputation is adopted, we recommend that imputation is carried out separately by randomized group. PMID:28034175

  6. Should multiple imputation be the method of choice for handling missing data in randomized trials?

    PubMed

    Sullivan, Thomas R; White, Ian R; Salter, Amy B; Ryan, Philip; Lee, Katherine J

    2016-01-01

    The use of multiple imputation has increased markedly in recent years, and journal reviewers may expect to see multiple imputation used to handle missing data. However in randomized trials, where treatment group is always observed and independent of baseline covariates, other approaches may be preferable. Using data simulation we evaluated multiple imputation, performed both overall and separately by randomized group, across a range of commonly encountered scenarios. We considered both missing outcome and missing baseline data, with missing outcome data induced under missing at random mechanisms. Provided the analysis model was correctly specified, multiple imputation produced unbiased treatment effect estimates, but alternative unbiased approaches were often more efficient. When the analysis model overlooked an interaction effect involving randomized group, multiple imputation produced biased estimates of the average treatment effect when applied to missing outcome data, unless imputation was performed separately by randomized group. Based on these results, we conclude that multiple imputation should not be seen as the only acceptable way to handle missing data in randomized trials. In settings where multiple imputation is adopted, we recommend that imputation is carried out separately by randomized group.

  7. Comparative study on treatment satisfaction and health perception in children and adolescents with type 1 diabetes mellitus on multiple daily injection of insulin, insulin pump and sensor-augmented pump therapy.

    PubMed

    Hussain, Tara; Akle, Mariette; Nagelkerke, Nico; Deeb, Asma

    2017-01-01

    Diabetes management imposes considerable demands on patients. Treatment method used has an impact on treatment satisfaction. We aim to examine the relationship between treatment satisfaction and health perception with the method used for treatment of type 1 diabetes mellitus in children and adolescents. We have interviewed patients with type 1 diabetes mellitus using questionnaires to assess treatment satisfaction and health perception. Patients were divided into three groups based on treatment used: multiple daily injection, insulin pump and sensor-augmented pump therapy. Comparison of scores was done between the groups. A total of 72 patients were enrolled (36 males). Mean age (standard deviation) was 11.4 (4.4) years and duration of diabetes of 4.9 (3.5) years. Mean (standard deviation) HbA1c was 8.1 (1.2). Median (range) duration of sensor use was 17.7 (3-30) days/month. Mean scale for treatment satisfaction and health perception questions was 25.3, 29.7 and 31.7 and 60, 79.7 and 81 for the multiple daily injection, pump and sensor-augmented pump, respectively (p = 0.00). Significant difference was seen between the multiple daily injection and both other groups. Sensor-augmented pump group scored higher than the pump group. However, the difference was not statistically significant. Duration of sensor use showed no correlation with treatment satisfaction. The method used for diabetes treatment has an impact on patients' satisfaction and health perception in children and adolescents with type 1 diabetes mellitus. Insulin pump users have a higher treatment satisfaction and better health perception than those on multiple daily injection. Augmenting pump therapy with sensor use adds value to treatment satisfaction without correlation with the duration of the sensors use.

  8. Consensus Statement on medication use in multiple sclerosis by the Spanish Society of Neurology's study group for demyelinating diseases.

    PubMed

    García-Merino, A; Fernández, O; Montalbán, X; de Andrés, C; Oreja-Guevara, C; Rodríguez-Antigüedad, A; Arbizu, T

    2013-01-01

    Treatments for multiple sclerosis therapy are rapidly evolving. It is believed that new drugs will be approved in the near future, thereby changing current indications for treatment. In this context, the Spanish Society of Neurology's study group on demyelinating diseases, which evaluates medication use in MS, has decided to draw up a consensus statement on the current indications and guidelines for multiple sclerosis treatment. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

  9. A Telerehabilitation Program Improves Postural Control in Multiple Sclerosis Patients: A Spanish Preliminary Study

    PubMed Central

    Ortiz-Gutiérrez, Rosa; Cano-de-la-Cuerda, Roberto; Galán-del-Río, Fernando; Alguacil-Diego, Isabel María; Palacios-Ceña, Domingo; Miangolarra-Page, Juan Carlos

    2013-01-01

    Postural control disorders are among the most frequent motor disorder symptoms associated with multiple sclerosis. This study aims to demonstrate the potential improvements in postural control among patients with multiple sclerosis who complete a telerehabilitation program that represents a feasible alternative to physical therapy for situations in which conventional treatment is not available. Fifty patients were recruited. Control group (n = 25) received physiotherapy treatment twice a week (40 min per session). Experimental group (n = 25) received monitored telerehabilitation treatment via videoconference using the Xbox 360® and Kinect console. Experimental group attended 40 sessions, four sessions per week (20 min per session).The treatment schedule lasted 10 weeks for both groups. A computerized dynamic posturography (Sensory Organization Test) was used to evaluate all patients at baseline and at the end of the treatment protocol. Results showed an improvement over general balance in both groups. Visual preference and the contribution of vestibular information yielded significant differences in the experimental group. Our results demonstrated that a telerehabilitation program based on a virtual reality system allows one to optimize the sensory information processing and integration systems necessary to maintain the balance and postural control of people with multiple sclerosis. We suggest that our virtual reality program enables anticipatory PC and response mechanisms and might serve as a successful therapeutic alternative in situations in which conventional therapy is not readily available. PMID:24185843

  10. Atorvastatin calcium in combination with methylprednisolone for the treatment of multiple sclerosis relapse.

    PubMed

    Li, Xiao-ling; Zhang, Zhen-chang; Zhang, Bo; Jiang, Hua; Yu, Chun-mei; Zhang, Wen-jing; Yan, Xiang; Wang, Man-xia

    2014-12-01

    This study aimed to investigate the efficacy of combined atorvastatin calcium and methylprednisolone for the treatment of multiple sclerosis relapse. Patients with multiple sclerosis (MS) at the relapse phase were randomized to receive either combined treatment of atorvastatin calcium and methylprednisolone (n = 19) or methylprednisolone alone (n = 19). Expanded Disability Status Scale (EDSS) was administered at baseline, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months after treatment initiation. The number and volume of brain lesions were evaluated using magnetic resonance imaging at baseline and 6 months. The levels of IL-13, IL-35, IFN-γ, and IL-10 in the cerebrospinal fluid were examined using the enzyme-linked immunosorbent assay method. There was no significant difference in EDSS scores at 1, 2, and 4 weeks. At 3 and 6 months, the combined treatment group showed significantly lower EDSS scores than the monotherapy group (P < 0.05). The number and volume of brain lesions in the combined treatment group were significantly lower than the monotherapy group at 6 months (P < 0.001). The mean time to relapse was significantly extended in the combined treatment group than the monotherapy group (P < 0.001). At 2 and 4 weeks, the combined treatment group had significantly higher levels of IL-13, IL-35, and IL-10 in the cerebrospinal fluid than the monotherapy group (P < 0.05), but significantly lower level of IFN-γ (P < 0.001). The levels of IL-13 and IL-10 in the combined treatment group were positively correlated with EDSS scores (r = 0.632, P = 0.001; r = 0.731, P = 0.002). Combined treatment with atorvastatin calcium and methylprednisolone can improve the outcomes of MS relapse compared with glucocorticosteroid alone. Copyright © 2014 Elsevier B.V. All rights reserved.

  11. Management of patients with rectocele, multiple pelvic floor dysfunctions and obstructed defecation syndrome.

    PubMed

    Murad-Regadas, Sthela Maria; Regadas, Francisco Sergio P; Rodrigues, Lusmar Veras; Fernandes, Graziela Olivia da Silva; Buchen, Guilherme; Kenmoti, Viviane T

    2012-01-01

    Management of patients with obstructed defecation syndrome is still controversial. To analyze the efficacy of clinical, clinical treatment followed by biofeedback, and surgical treatment in patients with obstructed defecation, rectocele and multiple dysfunctions evaluated with echodefecography. The study included 103 females aged 26-84 years with obstructed defecation, grade-II/III rectocele and multiple dysfunctions on echodefecography. Patients were distributed into three treatment groups and constipation scores were assigned. Group I: 34 (33%) patients with significant improvement of symptoms through clinical management only. Group II: 14 (14%) with improvement through clinical treatment plus biofeedback. Group III: 55 (53%) referred to surgery due to treatment failure. Group I: 20 (59%) patients had grade-II rectocele, 14 (41%) grade-III. Obstructed defecation syndrome was associated with intussusception (41%), mucosal prolapse (41%), anismus (29%), enterocele (9%) or 2 dysfunctions (23%). The average constipation score decreased significantly from 11 to 5. Group II: 11 (79%) grade-II rectocele, 3 (21%) grade-III, associated with intussusception (7%), mucosal prolapse (43%), anismus (71%) or 2 dysfunctions (29%). There was significant decrease in constipation score from 13 to 6. Group III: 8 (15%) grade-II rectocele, 47 (85%) grade-III, associated with intussusception (42%), mucosal prolapse (40%) or 2 dysfunctions (32%). The constipation score remained unchanged despite clinical treatment and biofeedback. Twenty-three underwent surgery had a significantly decrease in constipation score from 12 to 4. The remaining 32 (31%) patients which 22 refused surgery, 6 had low anal pressure and 4 had slow transit. Approximately 50% of patients with obstructed defecation, rectocele and multiple dysfunctions presented a satisfactory response to clinical treatment and/or biofeedback. Surgical repair was mainly required in patients with grade-III rectocele whose constipation scores remained high despite all efforts.

  12. Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

    PubMed

    Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

    2018-06-18

    Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

  13. Interferon-alpha and transfer factor in the treatment of multiple sclerosis: a double-blind, placebo-controlled trial. AUSTIMS Research Group.

    PubMed Central

    1989-01-01

    The role of interferon-alpha (IFN-alpha) and transfer factor (TF) in the treatment of multiple sclerosis was investigated in a prospective, multi-centric, three year, double-blind, placebo-controlled trial. One hundred and eighty two patients with clinically definite multiple sclerosis were randomised into three treatment groups whose compositions were found to be similar for demographic and prognostic variables including HLA status. Subcutaneous injections of IFN-alpha (3 x 10(6) units), TF (0.5 units) manufactured from leucocytes of cohabiting donors, or placebo were given twice weekly for two months, once weekly for 10 months then fortnightly for 24 months. One hundred and fifty three patients completed the injection regimen. There was no significant difference in the progression of disability for multiple sclerosis patients in either the IFN-alpha or TF-treated groups compared with the placebo group. Similarly, change in visual evoked responses (VER), and in number of oligoclonal bands (OCB) and the level of myelin basic protein (MBP) in the cerebrospinal fluid (CSF) over the trial period did not differ significantly between the three groups. However, the IFN-alpha-treated group had significantly more reported adverse drug reactions and patient withdrawals than either of the other two groups. PMID:2659737

  14. Effects on Cognition of Stereotactic Lesional Surgery For the Treatment of Tremor in Multiple Sclerosis

    PubMed Central

    Jahanshahi, Marjan; Pieter, Socorro; Alusi, Sundus H.; Jones, Catherine R. G.; Glickman, Scott; Stein, John; Aziz, Tipu; Bain, Peter G.

    2008-01-01

    Objective: To assess the effect of stereotactic lesional surgery for treatment of tremor in multiple sclerosis on cognition. Methods: Eleven patients (3 males, 8 females) with multiple sclerosis participated in the study. Six subjects comprised the surgical group and five the matched control group. All patients were assessed at baseline and three months using a neuropsychological test battery that included measures of intellectual ability, memory, language, perception and executive function. Results: There were no significant differences between the surgical and control groups and no change from pre to post testing except for a decline in scores on the Mini-Mental State Examination (MMSE), WAIS-R Digit Span and Verbal Fluency in the surgical group. Conclusions: The results indicate that stereotactic lesional surgery does not result in major cognitive impairment in multiple sclerosis. However, the decline in MMSE scores, digit span and verbal fluency require further investigation in a larger sample. PMID:19491469

  15. [Anatomy character of renal artery and treatment of living-donor renal transplantation].

    PubMed

    Zhang, Lei; Fei, Ji-guang; Chen, Li-zhong; Wang, Chang-xi; Deng, Su-xiong; Qiu, Jiang; Li, Jun; Chen, Guo-dong; Huang, Gang

    2009-12-15

    To study the anatomy characters of renal artery and the treatment of multiple arteries in living donor renal grafts. Records of 142 living donors were analyzed in our center. We analyzed the anatomic structure of renal arteries by DSA and CTA pre-transplantation. Thirty-one kidneys with multiple arteries were transplanted after reconstruction. Then clinical effects were compared between multiple-renal-arteries group (n=31) and single-renal-artery group (n=111). The incidence of multiple renal artery was 30.99%, and there was no difference between both sides (left kidney 22.54%, right kidney 22.13%). If the multiple artery occurred in left or right kidney, the incidence of the multiple artery occurred in the other side was 56.25% and 60.00%, respectively. The diameter of left main renal artery was more magnanimous (P=0.001) and the first branch was more closed to abdominal aorta (P=0.004). Operation time and warm/cool ischemia time were longer in the multiple-renal-arteries group. However, estimated blood loss, delayed graft function, acute rejection and flow rate of arcuate artery were similar in both groups, the same as serum creatinine and serum creatinine clearance rate on day 7, 1 month and 3 month post-operation. It was shown by repeated measures ANOVA that graft with multiple arteries didn't affect the tendency of renal function at early time post-operation. Comprehending the character of renal artery and accurate treatment of multiple artery anastomosis are critical for the effect of the living kidney transplantation.

  16. Developing a technique to master multiplication facts 6 to 9 for year 5 pupils

    NASA Astrophysics Data System (ADS)

    Ahmat, Norhayati; Mohamed, Nurul Huda; Azmee, Nor Afzalina; Adham, Sarah Mohd

    2017-05-01

    This study was performed to enhance the mastery of multiplication facts 6 to 9 amongst the year 5 pupils. The samples of this study were 40 pupils of year 5 from one of primary school at Teluk Intan, Perak. The samples were divided into two groups, the control group and the treatment group where each group consists of 20 pupils respectively. In this study, new multiplication facts technique, known as `Teknik Sifir Jari' has been introduced to the treatment group. The objectives of the study are to test the effectiveness of the new technique and to increase multiplication fact fluency among pupils. The instruments that have been used in this study are the achievement tests (pre-test and post-test). The data obtained were collected and analyzed using SPSS version 21.A t-test had also been carried out to test the null hypothesis. The results showed that there was an increment in the students' achievement for the students who were taught using the `Teknik Sifir Jari'. Therefore, the `Teknik Sifir Jari' has proved its effectiveness to support students in mastering multiplication facts.

  17. Multiple Family Group Counseling

    ERIC Educational Resources Information Center

    Sauber, S. Richard

    1971-01-01

    This article describes the innovative, short term approach of multiple family group counseling in which the counseling applies the principles and dynamics found in family and group counseling to the treatment of the student and his family. Several family units met together to discuss the problems that adversely affect the adolescent and result in…

  18. Estimating Statistical Power When Making Adjustments for Multiple Tests

    ERIC Educational Resources Information Center

    Porter, Kristin E.

    2016-01-01

    In recent years, there has been increasing focus on the issue of multiple hypotheses testing in education evaluation studies. In these studies, researchers are typically interested in testing the effectiveness of an intervention on multiple outcomes, for multiple subgroups, at multiple points in time or across multiple treatment groups. When…

  19. [Assessment of the pain patients with the multiple sclerosis after applying the physiotherapy treatment].

    PubMed

    Kubsik, Anna; Klimkiewicz, Robert; Klimkiewicz, Paulina; Janczewska, Katarzyna; Jankowska, Agnieszka; Łukasiak, Adam; Woldańska-Okońska, Marta

    2016-04-01

    Multiple sclerosis is one of the most common demyelinating disease of the CNS connected with the autoimmune action. The effect of the disease is progressive disability, and one of the symptoms is pain. In relieving pain in the course of MS physical procedures and exercises of physiotherapy are used. The aim of the study was assessment of the pain in patients with the multiple sclerosis after applying laser radiation, magnetostimulation and kinesiotherapy. The studied material was consisted of 120 patients with multiple sclerosis of both sexes (82 women and 38 men) aged 21-81 years. Patients were randomly divided into 4 treatment groups and the assesment was performed three times. In the first group laser therapy, in the group II laser and magnetostimulation, in the third group kinesiotherapy, in the fourth group magnetostimulation was used. The same program of physiotherapy in all groups was used. All patients were performed the following tests to assess of the pain: The Laitinen Modified Questionnaire Indicators of Pain of and the Visual- Analogue Scale (VAS). In all treatment groups was observed tends to decrease a result of a point in The Laitinen Modified Questionnaire Indicators of Pain and the Visual-Analogue Scale (VAS). Correlation between groups demonstrated statistically significant result on the level p<0.05 in the group where the laser treatment was applied towards group II assessed with parameter of the Questionnaire of Pain according to Laitinen, as well as towards group II and III assessed with parameter - of the Visual Analogue Scale (VAS). The good result, i.e. the reduction of the spot value, after the III examination towards the preliminary examination were got in the group II. Laser radiation is an effective method which has an analgesisc action. The combination of laser radiation and magnetostimulation reduces pain in patients with multiple sclerosis, and also allows to maintain a therapeutic effect even after the cessation of the application of these procedures, which indicates the possibility to elicitation the biological phenomenon of hysteresis in these methods. © 2016 MEDPRESS.

  20. Statistical Power in Evaluations That Investigate Effects on Multiple Outcomes: A Guide for Researchers

    ERIC Educational Resources Information Center

    Porter, Kristin E.

    2018-01-01

    Researchers are often interested in testing the effectiveness of an intervention on multiple outcomes, for multiple subgroups, at multiple points in time, or across multiple treatment groups. The resulting multiplicity of statistical hypothesis tests can lead to spurious findings of effects. Multiple testing procedures (MTPs) are statistical…

  1. Latin American algorithm for treatment of relapsing-remitting multiple sclerosis using disease-modifying agents.

    PubMed

    Finkelsztejn, Alessandro; Gabbai, Alberto Alain; Fragoso, Yara Dadalti; Carrá, Adriana; Macías-Islas, Miguel Angel; Arcega-Revilla, Raul; García-Bonitto, Juan; Oehninger-Gatti, Carlos Luis; Orozco-Escobar, Geraldine; Tarulla, Adriana; Vergara, Fernando; Vizcarra, Darwin

    2012-10-01

    It is estimated that circa 50,000 individuals have relapsing-remitting multiple sclerosis in Latin America. European and North-American algorithms for the treatment of multiple sclerosis do not foresee our regional difficulties and the access of patients to treatment. The Latin American Multiple Sclerosis Forum is an independent and supra-institutional group of experts that has assessed the latest scientific evidence regarding efficacy and safety of disease-modifying treatments. Accesses to treatment and pharmacovigilance programs for each of the eight countries represented at the Forum were also analyzed. A specific set of guidelines based upon evidence-based recommendations was designed for Latin America. Future perspectives of multiple sclerosis treatment were also discussed. The present paper translated an effort from representatives of eight countries discussing a matter that cannot be adapted to our region directly from purely European and North-American guidelines for treatment.

  2. [Preclinical treatment of multiple trauma : what is important?].

    PubMed

    Schweigkofler, U; Hoffmann, R

    2013-09-01

    Multiple trauma is still the most common cause of death in the age group below 40 years but rarely occurs in prehospital emergencies in Germany. Therefore, personal experience of emergency physicians in prehospital treatment of multiple trauma is often limited. Priority-based therapy according to standardized algorithms and advances in clinical and intensive care have reduced hospital mortality down to 13 %. Time factors, treatment and transport by Helicopter Emergency Medical Services seem to have had a significant impact on the outcome. The current German multiple trauma S3 guidelines provide algorithms for preclinical treatment. The underlying scientific evidence in this respect is, however, low.

  3. Gamma knife treatment for refractory epilepsy in seizure focus localized by positron emission tomography/CT★

    PubMed Central

    Bai, Xia; Wang, Xuemei; Wang, Hongwei; Zhao, Shigang; Han, Xiaodong; Hao, Linjun; Wang, Xiangcheng

    2012-01-01

    A total of 80 patients with refractory epilepsy were recruited from the Inner Mongolia Medical College Affiliated Hospital. The foci of 60% of the patients could be positioned using a combined positron emission tomography/CT imaging modality. Hyper- and hypometabolism foci were examined as part of this study. Patients who had abnormal metabolism in positron emission tomography/CT imaging were divided into intermittent-phase group and the seizure-phase group. The intermittent-phase group was further divided into a single-focus group and a multiple-foci group according to the number of seizure foci detected by imaging. Following gamma knife treatment, seizure frequency was significantly lower in the intermittent-phase group and the seizure-phase group. Wieser’s classification reached Grade I or II in nearly 40% of patients. Seizure frequency was significantly lower following treatment, but Wieser’s classification score was significantly higher in the seizure-phase group compared with the intermittent-phase group. Seizure frequency was significantly lower following treatment in the single-focus group, but Wieser’s classification score was significantly higher in the single-focus group as compared with the multiple-foci group. PMID:25317147

  4. Therapist, Parent, and Youth Perspectives of Treatment Barriers to Family-Focused Community Outpatient Mental Health Services

    PubMed Central

    Jenkins, Melissa M.; Haine-Schlagel, Rachel

    2012-01-01

    This exploratory qualitative study describes treatment barriers to receiving family-focused child mental health services for youths with disruptive behavior problems from multiple perspectives. Data were collected during a series of focus groups and interviews, including: 4 therapist focus groups, 3 parent focus groups, and 10 youth semi-structured interviews. Therapist, parent, and youth stakeholder participants discussed perceived barriers to effective treatment, the problems with current child outpatient therapy, and desired changes (i.e., policy, intervention, etc.) to improve mental health services. Results indicate similar themes around treatment barriers and dissatisfaction with services within and across multiple stakeholder groups, including inadequate support and lack of family involvement; however, parents and therapists, in particular, identified different contributing factors to these barriers. Overall, stakeholders reported much frustration and dissatisfaction with current community-based outpatient child therapy services. Study findings can inform service provision, intervention development, and future research. PMID:24019737

  5. Potential Benefits of Rib Fracture Fixation in Patients with Flail Chest and Multiple Non-flail Rib Fractures.

    PubMed

    Qiu, Meiguang; Shi, Zhanjun; Xiao, Jun; Zhang, Xuming; Ling, Shishui; Ling, Hao

    2016-12-01

    The purpose of this study is to evaluate the potential benefits of rib fracture fixation in patients with flail chest and multiple non-flail rib fractures versus conventional treatment modalities. A retrospective reviewed study compared 86 cases which received surgical treatment between June 2009 and May 2013 to 76 cases which received conservative treatment between January 2006 and May 2009. The patients were divided into the flail chest ( n  = 38) and multiple non-flail rib fracture groups ( n  = 124). In the flail chest group, the mechanical ventilation time, ICU monitoring time, tracheostomies, thoracic deformity, and impaired pulmonary function and return to full-time employment were compared. In the multiple non-flail rib fracture group, fracture healing, visual analog scale (VAS) pain score, inpatient length of stay, atelectatic, pulmonary complications, and normal activity-returning time were compared. Patients in the flail chest operative fixation group had significantly shorter ICU stay, decreased ventilator requirements, fewer tracheostomies, less thoracic deformity and impaired pulmonary function, and more returned to full-time employment. Patients in the multiple non-flail rib fracture operative fixation had shorter hospital stay, less pain, earlier return to normal activity, more fracture healing, less atelectasis, and fewer pulmonary infections. This study demonstrates the potential benefits of surgical stabilization of flail chest and multiple non-flail rib fractures with plate fixation. When compared with conventional conservative management, operatively managed patients demonstrated improved clinical outcomes.

  6. Evaluation of TNF-α serum level in patients with recalcitrant multiple common warts, treated by lipid garlic extract.

    PubMed

    Kenawy, Soha; Mohammed, Ghada Farouk; Younes, Soha; Elakhras, Atef Ibrahim

    2014-01-01

    No universal consensus about optimal modality for treating the recalcitrant multiple common warts (RMCW). The objective of the study was to evaluate the immunological mechanisms and clinical therapeutic effect of using lipid garlic extract (LGE) in the treatment of RMCW. The study included 50 patients with RMCW. They were randomly assigned into two groups: the first group (25 patients) received LGE, and the second group (25 patients) received saline as a control group. In both groups, treatments were made to single lesions, or largest wart in case of multiple lesions, until complete clearance of lesions or for a maximum of 4 weeks. Blood serum was taken at pre-study and at the fourth week to measure tumor necrosis factor alpha (TNF-α) level. A significant difference was found between the therapeutic responses of RMCW to LGE antigen and saline control group (p < 0.001). In the LGE group, complete response was achieved in 96% of patients presenting with RMCW. There was a statistically nonsignificant increase in TNF-α of LGE group versus saline group. No recurrence was observed in the LGE group. LGE as an immunotherapy is an inexpensive, effective, and safe modality with good cure rates for treatment of RMCWs, when other topical or physical therapies have failed. © 2014 Wiley Periodicals, Inc.

  7. Comparison of interferon beta products and azathioprine in the treatment of relapsing-remitting multiple sclerosis.

    PubMed

    Etemadifar, M; Janghorbani, M; Shaygannejad, V

    2007-12-01

    We compared the relative efficacy of interferon beta (IFNbeta) products and azathioprine (AZA) in the treatment of relapsing- remitting multiple sclerosis (RRMS). Ninety-four previously untreated patients of short duration with RRMS were randomly allocated to the two treatment groups. The first group received IFNbeta products (Betaferon,Avonex or Rebif); the second group received AZA for 12 months. Response to treatment was assessed at 3, 6, and 12 months after starting therapy. The mean number of relapse during one year of the study was lower in the AZA group than in the IFNbeta products group (0.28 vs. 0.64, P < 0.05). After 12 months, 57.4% of patients receiving IFNbeta products remained relapse free compared with 76.6% of those given AZA. The Expanded Disability Status Scale (EDSS) decreased by 0.30 units in IFNbeta-treated patients (P < 0.05) and 0.46 in AZAtreated patients (P < 0.001). Treatment with IFNbeta products and AZA significantly reduces the relapse rate and EDSS score in patients with RRMS, while AZA is more effective than the IFNbeta formulations.

  8. Statistical Power in Evaluations That Investigate Effects on Multiple Outcomes: A Guide for Researchers

    ERIC Educational Resources Information Center

    Porter, Kristin E.

    2016-01-01

    In education research and in many other fields, researchers are often interested in testing the effectiveness of an intervention on multiple outcomes, for multiple subgroups, at multiple points in time, or across multiple treatment groups. The resulting multiplicity of statistical hypothesis tests can lead to spurious findings of effects. Multiple…

  9. Coronally advanced flap with and without a xenogenic collagen matrix in the treatment of multiple recessions: a randomized controlled clinical study.

    PubMed

    Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena

    2014-01-01

    Multiple adjacent recession defects were treated in 32 patients using a coronally advanced flap (CAF) with or without a collagen matrix (CM). The percentage of root coverage was 81.49% ± 23.45% (58% complete root coverage) for CAF sites (control) and 93.25% ± 10.01% root coverage (72% complete root coverage) for CM plus CAF sites (test). The results achieved in the test group were significantly greater than in the control group, indicating that CM plus CAF is a suitable option for the treatment of multiple adjacent gingival recessions.

  10. Multiple Sclerosis-related Uveitis: Does MS Treatment Affect Uveitis Course?

    PubMed

    Jouve, Léa; Benrabah, Rabah; Héron, Emmanuel; Bodaghi, Bahram; Le Hoang, Phuc; Touitou, Valérie

    2017-06-01

    Few data are available regarding the optimal treatment of multiple sclerosis (MS)-related uveitis. The aim of this study was to describe clinical features of MS-associated uveitis and determine how MS treatment affects the course of uveitis. Retrospective, multicenter study. Patients were divided into two groups according to the use (group 2) or not (group 1) of immunomodulatory drugs. Characteristics of uveitis and treatment were reviewed. A total of 68 eyes from 36 patients (17 in group 1 and 19 in group 2) were included. All patients were treated with topical and/or systemic steroids for uveitis. Uveitis occurred 1-17 years prior to neurologic symptoms in 78% of patients. Uveitis was more severe in group 2 (p<0.05), with a tendency toward a higher rate of chronic uveitis (p = 0.06). MS-related uveitis has often a favorable evolution. Patients on interferon-beta have more severe and chronic uveitis. As far as we are concerned, interferon-beta given on the sole indication of uveitis is not recommended. If steroid-sparing agent is required for intraocular inflammation, immunosuppressive drugs should be considered.

  11. Vitamin C supplementation improve the sputum conversion culture rate in pulmonary tuberculosis treatment while rifampicin susceptible

    NASA Astrophysics Data System (ADS)

    Susanto, L.; Siregar, Y.; Kusumawati, L.

    2018-03-01

    The failure of first-line tuberculosis treatment greatly affects multiple drug-resistant tuberculosis. In vitro study of vitamin C induces the death of M. tuberculosis bacteria and accelerates healing of tuberculosis, so the multiple drug-resistant tuberculosis can be avoided. This research aimed to identify the effect of vitamin C as a supportive treatment on the sputum conversion rate. The randomizedand double group with a parallel design by matching pair method was used to collect samples. The first group was treated with standard tuberculosis treatment, and the other was given vitamin C supplementation. Vitamin C plasma level analyzation was performed before and after two months of treatment. Sputum conversion was evaluated every week for eight weeks. The comparison of vitamin C plasma level in pre and post-treatment group was significant (p=0.03) but not in the other group. There was no significant difference in vitamin C plasma level between two groups (p=0.21). The proportion of sputum conversion rate in both group in the first week was 0% vs. 9.6% (p=0.83) and the last week of study was 83.9% vs. 100% (p=0.02). In conclusion, vitamin C supplementation has effects in improving the healing process of tuberculosis patients as indicated by higher in sputum conversion rate.

  12. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study.

    PubMed

    Shaheen, Maha Adel; Salem, Samar Abdallah M; Fouad, Dina Adel; El-Fatah, Abeer Aly Abd

    2015-01-01

    Intralesional purified protein derivative (PPD) or mumps, measles, rubella (MMR) were not previously compared regarding their efficacy or mechanism of action in treatment of warts. We aimed to compare their efficacy in treatment of multiple warts and investigate their effect on serum interleukin (IL)-4 and IL-12. Thirty patients with multiple warts were included (10 treated with PPD, 10 with MMR, and 10 with normal saline (control)). Injection was done every 3 weeks until clearance or maximum of three treatments. Clinical response of target and distant warts was evaluated. Serum ILs-4 and -12 were assessed before and after treatment. A significantly higher rate of complete response was found in target and distant warts with PPD (60% each) and MMR (80%, 40%, respectively) compared with controls (0%), with no significant difference between both treatments. After treatment, the control group showed the lowest serum IL-12 and IL-4 levels compared with the MMR- and PPD-treated groups with statistically significant difference in between. MMR resulted in a significantly higher serum IL-12 than PPD. With PPD, IL-4 was increased with statistically significant change compared with pretreat-ment level. Intralesional PPD and MMR show comparable efficacy and safety in treatment of multiple warts. Serum ILs-4 and-12 increase following antigen injection. © 2015 Wiley Periodicals, Inc.

  13. Technology Integration and the Effect on Mathematics Fact Fluency in the Middle East

    ERIC Educational Resources Information Center

    Letwinsky, Karim Medico; Berry, Michael David

    2017-01-01

    This quantitative, quasi-experimental study investigated the effect of the Mathletics.com technology on basic multiplication fact fluency in fourth grade students in the Middle East. The treatment group received three weeks of scheduled time using Mathletics.com, while the control group practiced multiplication facts using only traditional…

  14. Pelvic Floor Muscle Training With and Without Electrical Stimulation in the Treatment of Lower Urinary Tract Symptoms in Women With Multiple Sclerosis.

    PubMed

    Lúcio, Adélia; Dʼancona, Carlos Arturo Levi; Perissinotto, Maria Carolina; McLean, Linda; Damasceno, Benito Pereira; de Moraes Lopes, Maria Helena Baena

    2016-01-01

    The aim of this study was to evaluate the effect of intravaginal neuromuscular electrical stimulation (NMES) and transcutaneous tibial nerve stimulation (TTNS) on lower urinary tract symptoms (LUTS) and health-related quality of life in women undergoing pelvic floor muscle (PFM) training (PFMT) with multiple sclerosis (MS) and to compare the efficacy of these 2 approaches. Randomized controlled trial. Thirty women with MS and LUTS were randomly allocated to 1 of 3 groups and received treatment for 12 weeks. Ten women in group 1 received PFMT with electromyographic (EMG) biofeedback and sham NMES. Ten women in group 2 underwent PFMT with EMG biofeedback and intravaginal NMES, and 10 subjects in group 3 received PFMT with EMG biofeedback and TTNS. Multiple assessments, performed before and after treatment, included a 24-hour pad test, 3-day bladder diary, assessment of PFM function (strength and muscle tone), urodynamic studies, and validated questionnaires including Overactive Bladder Questionnaire (OAB-V8), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Qualiveen instrument. All groups showed reductions in pad weight, frequency of urgency and urge urinary incontinence episodes, improvement in all domains of the PFM assessment, and lower scores on the OAB-V8 and ICIQ-SF questionnaires following treatment. Subjects in group 2 achieved significantly greater improvement in PFM tone, flexibility, ability to relax PFMs, and OAB-V8 scores when compared to subjects in groups 1 and 3. Results suggest that PFMT alone or in combination with intravaginal NMES or TTNS is effective in the treatment of LUTS in patients with MS. The combination of PFMT and NMES offers some advantage in the reduction of PFM tone and symptoms of overactive bladder.

  15. [Consensus document on spasticity in patients with multiple sclerosis. Grupo de Enfermedades Desmielinizantes de la Sociedad Española de Neurología].

    PubMed

    Oreja-Guevara, Celia; Montalban, Xavier; de Andrés, Clara; Casanova-Estruch, Bonaventura; Muñoz-García, Delicias; García, Inmaculada; Fernández, Óscar

    2013-10-16

    Multiple sclerosis is a chronic neurological inflammatory demyelinating disease. Specialists involved in the symptomatic treatment of this disease tend to apply heterogeneous diagnostic and treatment criteria. To establish homogeneous criteria for treating spasticity based on available scientific knowledge, facilitating decision-making in regular clinical practice. A group of multiple sclerosis specialists from the Spanish Neurological Society demyelinating diseases working group met to review aspects related to spasticity in this disease and draw up the consensus. After an exhaustive bibliographic search and following a metaplan technique, a number of preliminary recommendations were established to incorporate into the document. Finally, each argument was classified depending on the degree of recommendation according to the SIGN (Scottish Intercollegiate Guidelines Network) system. The resulting text was submitted for review by the demyelinating disease group. An experts' consensus was reached regarding spasticity triggering factors, related symptoms, diagnostic criteria, assessment methods, quality of life and therapeutic management (drug and non-drug) criteria. The recommendations included in this consensus can be a useful tool for improving the quality of life of multiple sclerosis patients, as they enable improved diagnosis and treatment of spasticity.

  16. Treatment optimization in MS: Canadian MS Working Group updated recommendations.

    PubMed

    Freedman, Mark S; Selchen, Daniel; Arnold, Douglas L; Prat, Alexandre; Banwell, Brenda; Yeung, Michael; Morgenthau, David; Lapierre, Yves

    2013-05-01

    The Canadian Multiple Sclerosis Working Group (CMSWG) developed practical recommendations in 2004 to assist clinicians in optimizing the use of disease-modifying therapies (DMT) in patients with relapsing multiple sclerosis. The CMSWG convened to review how disease activity is assessed, propose a more current approach for assessing suboptimal response, and to suggest a scheme for switching or escalating treatment. Practical criteria for relapses, Expanded Disability Status Scale (EDSS) progression and MRI were developed to classify the clinical level of concern as Low, Medium and High. The group concluded that a change in treatment may be considered in any RRMS patient if there is a high level of concern in any one domain (relapses, progression or MRI), a medium level of concern in any two domains, or a low level of concern in all three domains. These recommendations for assessing treatment response should assist clinicians in making more rational choices in their management of relapsing MS patients.

  17. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial.

    PubMed

    Poewe, Werner; Seppi, Klaus; Fitzer-Attas, Cheryl J; Wenning, Gregor K; Gilman, Sid; Low, Phillip A; Giladi, Nir; Barone, Paolo; Sampaio, Cristina; Eyal, Eli; Rascol, Olivier

    2015-02-01

    Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists. We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy. We did this randomised, double-blind, placebo-controlled trial between Dec 15, 2009, and Oct 20, 2011, at 40 academic sites specialised in the care of patients with multiple systemic atrophy across 12 countries. Eligible participants aged 30 years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned (1:1), via computer-generated block randomisation (block size of four), to receive either rasagiline 1 mg per day or placebo. Randomisation was stratified by study centre. The investigators, study funder, and personnel involved in patient assessment, monitoring, analysis and data management were masked to group assignment. The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale (UMSARS) score (parts I and II). Analysis was by modified intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00977665. We randomly assigned 174 participants to the rasagiline group (n=84) or the placebo group (n=90); 21 (25%) patients in the rasagiline group and 15 (17%) in the placebo group withdrew from the study early. At week 48, patients in the rasagiline group had progressed by an adjusted mean of 7·2 (SE 1·2) total UMSARS units versus 7·8 (1·1) units in those in the placebo group. This treatment difference of -0·60 (95% CI -3·68 to 2·47; p=0·70) was not significant. 68 (81%) patients in the rasagiline group and 67 (74%) patients in the placebo group reported adverse events, and we recorded serious adverse events in 29 (35%) versus 23 (26%) patients. The most common adverse events in the rasagiline group were dizziness (n=10 [12%]), peripheral oedema (n=9 [11%]), urinary tract infections (n=9 [11%]), and orthostatic hypotension (n=8 [10%]). In this population of patients with the parkinsonian variant of multiple system atrophy, treatment with rasagiline 1 mg per day did not show a significant benefit as assessed by UMSARS. The study confirms the sensitivity of clinical outcomes for multiple system atrophy to detect clinically significant decline, even in individuals with early disease. Teva Pharmaceutical Industries and H Lundbeck A/S. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Intersections of discrimination due to unemployment and mental health problems: the role of double stigma for job- and help-seeking behaviors.

    PubMed

    Staiger, Tobias; Waldmann, Tamara; Oexle, Nathalie; Wigand, Moritz; Rüsch, Nicolas

    2018-05-21

    The everyday lives of unemployed people with mental health problems can be affected by multiple discrimination, but studies about double stigma-an overlap of identities and experiences of discrimination-in this group are lacking. We therefore studied multiple discrimination among unemployed people with mental health problems and its consequences for job- and help-seeking behaviors. Everyday discrimination and attributions of discrimination to unemployment and/or to mental health problems were examined among 301 unemployed individuals with mental health problems. Job search self-efficacy, barriers to care, and perceived need for treatment were compared among four subgroups, depending on attributions of experienced discrimination to unemployment and to mental health problems (group i); neither to unemployment nor to mental health problems (group ii); mainly to unemployment (group iii); or mainly to mental health problems (group iv). In multiple regressions among all participants, higher levels of discrimination predicted reduced job search self-efficacy and higher barriers to care; and attributions of discrimination to unemployment were associated with increased barriers to care. In ANOVAs for subgroup comparisons, group i participants, who attributed discrimination to both unemployment and mental health problems, reported lower job search self-efficacy, more perceived stigma-related barriers to care and more need for treatment than group iii participants, as well as more stigma-related barriers to care than group iv. Multiple discrimination may affect job search and help-seeking among unemployed individuals with mental health problems. Interventions to reduce public stigma and to improve coping with multiple discrimination for this group should be developed.

  19. Matching weights to simultaneously compare three treatment groups: Comparison to three-way matching

    PubMed Central

    Yoshida, Kazuki; Hernández-Díaz, Sonia; Solomon, Daniel H.; Jackson, John W.; Gagne, Joshua J.; Glynn, Robert J.; Franklin, Jessica M.

    2017-01-01

    BACKGROUND Propensity score matching is a commonly used tool. However, its use in settings with more than two treatment groups has been less frequent. We examined the performance of a recently developed propensity score weighting method in the three treatment group setting. METHODS The matching weight method is an extension of inverse probability of treatment weighting (IPTW) that reweights both exposed and unexposed groups to emulate a propensity score matched population. Matching weights can generalize to multiple treatment groups. The performance of matching weights in the three-group setting was compared via simulation to three-way 1:1:1 propensity score matching and IPTW. We also applied these methods to an empirical example that compared the safety of three analgesics. RESULTS Matching weights had similar bias, but better mean squared error (MSE) compared to three-way matching in all scenarios. The benefits were more pronounced in scenarios with a rare outcome, unequally sized treatment groups, or poor covariate overlap. IPTW’s performance was highly dependent on covariate overlap. In the empirical example, matching weights achieved the best balance for 24 out of 35 covariates. Hazard ratios were numerically similar to matching. However, the confidence intervals were narrower for matching weights. CONCLUSIONS Matching weights demonstrated improved performance over three-way matching in terms of MSE, particularly in simulation scenarios where finding matched subjects was difficult. Given its natural extension to settings with even more than three groups, we recommend matching weights for comparing outcomes across multiple treatment groups, particularly in settings with rare outcomes or unequal exposure distributions. PMID:28151746

  20. Labial adhesions and outcomes of office management.

    PubMed

    Granada, Catalina; Sokkary, Nancy; Sangi-Haghpeykar, Haleh; Dietrich, Jennifer E

    2015-04-01

    To evaluate clinical outcomes of labial adhesions (LA) and to examine the association between LA, lichen sclerosus (LS), eczema (ECZ), or asthma. Retrospective study. Single pediatric and adolescent gynecology clinic, Houston, Texas. 50 girls diagnosed with LA from 2006-2011. Resolution, recurrence, single vs multiple treatments, need for surgery, and conditions such as LS, ECZ, and asthma were reviewed. Mean age was 19.6 months (range 0-84 months), and 48% were Caucasian. Most patients were symptomatic (62%) and all 50 patients chose estrogen treatment. The majority (74%) required multiple treatments, as opposed to a single treatment (26%). Patients with multiple treatments were more likely to be severely agglutinated (P = .05) and to need manual separation after failed topical treatment (P = .08). The prevalence of asthma, LS, and ECZ was 9.8%, 7.8%, and 3.9% respectively. There was no association between LS, ECZ, or asthma, and number of treatments. Both asthma (N = 3; 8%), and LS (N = 2; 5%) were present among the severe agglutinated group; however, this difference was not statistically significant (P values .59 and .99). No association with ECZ was seen in either group. Severe agglutination tends to be associated with need of multiple treatments and manual separation. A concurrent diagnosis of LS, ECZ, or asthma was not associated with number of treatments but there appears to be a trend towards severity of LA in patients with asthma and LS. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  1. Multiple drilling combined with simvastatin versus multiple drilling alone for the treatment of avascular osteonecrosis of the femoral head: 3-year follow-up study.

    PubMed

    Yin, Han; Yuan, Zhenfeng; Wang, Dawei

    2016-08-15

    Multiple small drilling for core decompression is widely used to preserve the femoral head in patients with avascular necrosis of the femoral head (ANFH). Nevertheless, the clinical outcome remains controversial. Simvastatin has been demonstrated to promote bone formation and reduce bone adsorption. The purpose of this study was to determine whether simvastatin enhanced the effect of multiple decompressions in preventing progression of ANFH and to identify independent risk factors associated with poor results. We retrospectively analyzed 58 hips in 36 patients, with a follow-up of 36 months. 20 patients (32 hips) underwent multiple drilling combined with simvastatin treatment (SIM group); 16 patients (26 hips) underwent multiple drilling alone (MD group). We defined clinical failure as a requirement for subsequent hip surgery or Harris Hip Score < 75. New occurrence of collapse or increased collapse > 2 mm on plain radiographs was defined as radiological failure. Successful clinical results were achieved in 27 of 32 hips (84 %) in the SIM group compared with 15 of 26 hips (58 %) in the MD group (OR = 0.2, CI (0.1, 0.6.), P = 0.032). Successful radiological results were achieved in 27 of 32 hips (84 %) in the SIM group and in 16 of 26 hips (61.5 %) in the MD group (P = 0.048). Body mass index, disease stage and location of lesion were independent prognostic factors for overall survival. We believe that simvastatin could enhance the effects of multiple decompressions in preventing progression of ANFH and reducing the risk of femoral head collapse.

  2. Comparison of clinical outcomes and genomic characteristics of single focus and multifocal glioblastoma

    PubMed Central

    Paulsson, Anna K.; Holmes, Jordan A.; Peiffer, Ann M.; Miller, Lance D.; Liu, Wennuan; Xu, Jianfeng; Hinson, William H.; Lesser, Glenn J.; Laxton, Adrian W.; Tatter, Stephen B.; Debinski, Waldemar

    2014-01-01

    We investigate the differences in molecular signature and clinical outcomes between multiple lesion glioblastoma (GBM) and single focus GBM in the modern treatment era. Between August 2000 and May 2010, 161 patients with GBM were treated with modern radiotherapy techniques. Of this group, 33 were considered to have multiple lesion GBM (25 multifocal and 8 multicentric). Patterns of failure, time to progression and overall survival were compared based on whether the tumor was considered a single focus or multiple lesion GBM. Genomic groupings and methylation status were also investigated as a possible predictor of multifocality in a cohort of 41 patients with available tissue for analysis. There was no statistically significant difference in overall survival (p < 0.3) between the multiple lesion tumors (8.2 months) and single focus GBM (11 months). Progression free survival was superior in the single focus tumors (7.1 months) as compared to multi-focal (5.6 months, p = 0.02). For patients with single focus, multifocal and multicentric GBM, 81, 76 and 88 % of treatment failures occurred in the 60 Gy volume (p < 0.5), while 54, 72, and 38 % of treatment failures occurred in the 46 Gy volume (p < 0.4). Out of field failures were rare in both single focus and multiple foci GBM (7 vs 3 %). Genomic groupings and methylation status were not found to predict for multifocality. Patterns of failure, survival and genomic signatures for multiple lesion GBM do not appreciably differ when compared to single focus tumors. PMID:24990827

  3. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE).

    PubMed

    2017-03-30

    Objective  To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. Design  Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial). Setting  Eight secondary care centres in England and Scotland. Participants  Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections. Interventions  Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main outcome measures  The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. Results  317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was -0.85% with pump treatment and -0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was -0.24% (-2.7 mmol/mol) in favour of pump users (95% confidence interval -0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. Conclusions  Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. Trial registration  Current Controlled Trials ISRCTN61215213. 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.

  4. Optimization of treatment with interferon beta in multiple sclerosis. Usefulness of automatic system application criteria

    PubMed Central

    Ruiz-Peña, Juan Luís; Duque, Pablo; Izquierdo, Guillermo

    2008-01-01

    Background A software based tool has been developed (Optem) to allow automatize the recommendations of the Canadian Multiple Sclerosis Working Group for optimizing MS treatment in order to avoid subjective interpretation. Methods Treatment Optimization Recommendations (TORs) were applied to our database of patients treated with IFN β1a IM. Patient data were assessed during year 1 for disease activity, and patients were assigned to 2 groups according to TOR: "change treatment" (CH) and "no change treatment" (NCH). These assessments were then compared to observed clinical outcomes for disease activity over the following years. Results We have data on 55 patients. The "change treatment" status was assigned to 22 patients, and "no change treatment" to 33 patients. The estimated sensitivity and specificity according to last visit status were 73.9% and 84.4%. During the following years, the Relapse Rate was always higher in the "change treatment" group than in the "no change treatment" group (5 y; CH: 0.7, NCH: 0.07; p < 0.001, 12 m – last visit; CH: 0.536, NCH: 0.34). We obtained the same results with the EDSS (4 y; CH: 3.53, NCH: 2.55, annual progression rate in 12 m – last visit; CH: 0.29, NCH: 0.13). Conclusion Applying TOR at the first year of therapy allowed accurate prediction of continued disease activity in relapses and disability progression. PMID:18325088

  5. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma.

    PubMed

    Stewart, A Keith; Rajkumar, S Vincent; Dimopoulos, Meletios A; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S; Mihaylov, Georgi G; Goranova-Marinova, Vesselina; Rajnics, Péter; Suvorov, Aleksandr; Niesvizky, Ruben; Jakubowiak, Andrzej J; San-Miguel, Jesus F; Ludwig, Heinz; Wang, Michael; Maisnar, Vladimír; Minarik, Jiri; Bensinger, William I; Mateos, Maria-Victoria; Ben-Yehuda, Dina; Kukreti, Vishal; Zojwalla, Naseem; Tonda, Margaret E; Yang, Xinqun; Xing, Biao; Moreau, Philippe; Palumbo, Antonio

    2015-01-08

    Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P=0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P=0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P<0.001; 31.8% and 9.3% of patients in the respective groups had a complete response or better; 14.1% and 4.3% had a stringent complete response). Adverse events of grade 3 or higher were reported in 83.7% and 80.7% of patients in the carfilzomib and control groups, respectively; 15.3% and 17.7% of patients discontinued treatment owing to adverse events. Patients in the carfilzomib group reported superior health-related quality of life. In patients with relapsed multiple myeloma, the addition of carfilzomib to lenalidomide and dexamethasone resulted in significantly improved progression-free survival at the interim analysis and had a favorable risk-benefit profile. (Funded by Onyx Pharmaceuticals; ClinicalTrials.gov number, NCT01080391.).

  6. Postoperative Pain and Flare-Ups: Comparison of Incidence Between Single and Multiple Visit Pulpectomy in Primary Molars

    PubMed Central

    Gowda, Subhadra Halemane Nagaraj

    2017-01-01

    Introduction Endodontic treatment performed in either single- or multiple visit can be followed by numerous short- and long term complications. One of the short term complications include postoperative pain and flare–ups. The ability to predict its prevalence and forewarn the patient may go some way towards enabling coping strategies and help dentist in pain management treatment decisions Aim To compare the incidence and intensity of postoperative pain and flare-ups between single- and multiple visit pulpectomy in primary molars. Also, to correlate the preoperative status of the pulp to postoperative pain and flare-ups. Materials and Methods Eighty primary molars indicated for pulpectomy were included in the study and divided into two groups. Tooth treated and preoperative status of the pulp vitality was recorded. All the conventional steps in pulpectomy were followed. Teeth in Group 1 (single visit pulpectomy) were obturated on the same visit. Teeth in Group 2 (multiple visit pulpectomy) were obturated in the subsequent appointment. The recording of postoperative pain, flare-ups, use of medication were done after 24 hours, seven days and one month. Results Four cases in both the groups reported postoperative pain (10%) at 24 hour recall, p=0.74. One flare-up (2.5%) was recorded in each group p=0.67. None of the patients reported pain at seventh day and one month recall. Postoperative pain was recorded in five non-vital teeth (13.5%) and three vital teeth (6.9%). However, it was statistically not significant p=0.53. Conclusion From the perspective of our study there was a low incidence of postoperative pain. The majority of patients in both groups reported no pain or only minimal pain within 24 hours of treatment. There were no differences between single- and multi visit treatment protocols with respect to the incidence of postoperative pain. No significant correlation could be found between pulp vitality and the incidence of postoperative pain. PMID:28511499

  7. Obstetric outcomes in women with polycystic ovary syndrome and isolated polycystic ovaries undergoing in vitro fertilization: a retrospective cohort analysis.

    PubMed

    Wan, Hei Lok Tiffany; Hui, Pui Wah; Li, Hang Wun Raymond; Ng, Ernest Hung Yu

    2015-03-01

    This retrospective cohort study evaluated the obstetric outcomes in women with polycystic ovary syndrome (PCOS) and isolated polycystic ovaries (PCO) undergoing in vitro fertilization (IVF) treatment. We studied 104 women with PCOS, 184 with PCO and 576 age-matched controls undergoing the first IVF treatment cycle between 2002 and 2009. Obstetric outcomes and complications including gestational diabetes (GDM), gestational hypertension (GHT), gestational proteinuric hypertension (PET), intrauterine growth restriction (IUGR), gestation at delivery, baby's Apgar scores and admission to the neonatal intensive care unit (NICU) were reviewed. Among the 864 patients undergoing IVF treatment, there were 253 live births in total (25 live births in the PCOS group, 54 in the PCO group and 174 in the control group). The prevalence of obstetric complications (GDM, GHT, PET and IUGR) and the obstetric outcomes (gestation at delivery, birth weight, Apgar scores and NICU admissions) were comparable among the three groups. Adjustments for age and multiple pregnancies were made using multiple logistic regression and we found no statistically significant difference among the three groups. Patients with PCO ± PCOS do not have more adverse obstetric outcomes when compared with non-PCO patients undergoing IVF treatment.

  8. [Effects of pamidronate disodium (Bonin) combined with chemotherapy on bone pain in multiple myeloma].

    PubMed

    Leng, Yun; Chen, Shi-lun; Shi, Hong-zhi

    2002-10-01

    Objective. To evaluate the therapeutic effects of Disodium Pamidronate (Bonin) on bone pain in multiple myeloma. Method. 18 patients received only chemotherapy and 16 patients with addition of Bonin were compared. Result. The bone pain was significantly relieved both in chemotherapy alone group and in the combination group of Bonin with chemotherapy after treatment (P<0.01, as compared with before therapy). However, the effects of combination group were more dramatical than that of the other group (P<0.05). No obvious side-effects were observed except mild fever in one patient in the combination group. Conclusion. Bonin, as a safe and effective Bisphosphonates preparation, could relieve bone pain in multiple myeloma more effectively when combined with chemotherapy.

  9. Consensus statement on the treatment of multiple sclerosis by the Spanish Society of Neurology in 2016.

    PubMed

    García Merino, A; Ramón Ara Callizo, J; Fernández Fernández, O; Landete Pascual, L; Moral Torres, E; Rodríguez-Antigüedad Zarrantz, A

    2017-03-01

    With the advent of new disease-modifying drugs, the treatment of multiple sclerosis is becoming increasingly complex. Using consensus statements is therefore advisable. The present consensus statement, which was drawn up by the Spanish Society of Neurology's study group for demyelinating diseases, updates previous consensus statements on the disease. The present study lists the medications currently approved for multiple sclerosis and their official indications, and analyses such treatment-related aspects as activity, early treatment, maintenance, follow-up, treatment failure, changes in medication, and special therapeutic situations. This consensus statement includes treatment recommendations for a wide range of demyelinating diseases, from isolated demyelinating syndromes to the different forms of multiple sclerosis, as well as recommendations for initial therapy and changes in drug medication, and additional comments on induction and combined therapy and practical aspects of the use of these drugs. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  10. Assessment of NASA Dual Microstructure Heat Treatment Method for Multiple Forging Batch Heat Treatment

    NASA Technical Reports Server (NTRS)

    Gayda, John (Technical Monitor); Lemsky, Joe

    2004-01-01

    NASA dual microstructure heat treatment technology previously demonstrated on single forging heat treat batches of a generic disk shape was successfully demonstrated on a multiple disk batch of a production shape component. A group of four Rolls-Royce Corporation 3rd Stage AE2100 forgings produced from alloy ME209 were successfully dual microstructure heat treated as a single heat treat batch. The forgings responded uniformly as evidenced by part-to-part consistent thermocouple recordings and resultant macrostructures, and from ultrasonic examination. Multiple disk DMHT processing offers a low cost alternative to other published dual microstructure processing techniques.

  11. Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

    PubMed

    Rahn, Anne C; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; van de Roemer, Adrianus; Mühlhauser, Ingrid; Heesen, Christoph

    2016-09-20

    Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire's internal consistency was moderate (Cronbach's alpha = 0.56). The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. German Clinical Trials Register: DRKS00008561 . Registered 8th of June 2015.

  12. A pragmatic investigation into the effects of massage therapy on the self efficacy of multiple sclerosis clients.

    PubMed

    Finch, Paul; Bessonnette, Susan

    2014-01-01

    This research was conducted to examine changes in self self-efficacy, (the perception/belief that one can competently cope with a challenging situation) in multiple sclerosis clients following a series of massage therapy treatments. This small practical trial investigated the effects of a pragmatic treatment protocol using a prospective randomized pretest posttest waitlist control design. Self-Efficacy scores were obtained before the first treatment, mid-treatment series, after the last treatment in the series, four weeks after the final treatment and again eight weeks after the final treatment had been received. The intervention involved a series of weekly one hour therapeutic massage treatments conducted over eight weeks and a subsequent eight week follow up period. All treatments were delivered by supervised student therapists in the final term of their two year massage therapy program. Self-Efficacy [SE] was the outcome for the study, measured using the Multiple Sclerosis Self-Efficacy survey [MSSE]. Descriptive statistics for SE scores were assessed and inferential analysis involved the testing of between group differences at each of the measurement points noted above. Statistically significant improvement in self-efficacy was noted between treatment (n = 8) and control (n = 7) groups at mid treatment series (t = 2.32; p < 0.02), post treatment series (t = 1.81; p < 0.05) and at four week follow up (t = 2.24; p < 0.02). At the eight week follow up self-efficacy scores had decreased and there was no statistically significant difference between groups (t = 0.87; p < 0.2). Study results support previous findings indicating that massage therapy increases the self-efficacy of clients with multiple sclerosis, potentially resulting in a better overall adjustment to the disease and an improvement in psycho-emotional state. The increase in self-efficacy after 4 weeks of treatment suggests that positive response occurs more rapidly that was previously demonstrated. The improvement in self-efficacy endured 4 weeks after the end of the treatment series, which suggests that massage therapy may have longer term effects on self-efficacy that were not previously noted. Lack of inter group difference at the eight week follow up reinforces the notion that on-going treatment is required in order to maintain the positive changes observed. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Evolution in quality of life and epidemiological impact after endovascular treatment of chronic cerebro-spinal venous insufficiency in patients with multiple sclerosis.

    PubMed

    Beelen, R; Maene, L; Castenmiller, P; Decoene, V; Degrieck, I

    2012-03-01

    We report the outcome of 67 patients after endovascular treatment of chronic cerebro-spinal venous insufficiency in patients with multiple sclerosis. Material and methods For evaluating outcome, patients were divided into three groups with respective outcome after three, six and twelve months. Assessment of outcome was done by a disease-specific quality-of-life score that reflects the physical health (physical health composite, PHC) and mental health (mental health composite, MHC) by a score. Improvement in PHC was significant (P < 0.05) in the three- and six-month groups. Improvement in MHC was only significant (P < 0.05) in the three-month group. In conclusion, we can state that the result of endovascular treatment seems to decay although the baseline is still higher than preoperative. To confirm this finding, this study needs to be reproduced in a larger patient population.

  14. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.

    PubMed

    Hermanides, J; Nørgaard, K; Bruttomesso, D; Mathieu, C; Frid, A; Dayan, C M; Diem, P; Fermon, C; Wentholt, I M E; Hoekstra, J B L; DeVries, J H

    2011-10-01

    To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group. Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

  15. Recommendations of the Global Multiple System Atrophy Research Roadmap Meeting.

    PubMed

    Walsh, Ryan R; Krismer, Florian; Galpern, Wendy R; Wenning, Gregor K; Low, Phillip A; Halliday, Glenda; Koroshetz, Walter J; Holton, Janice; Quinn, Niall P; Rascol, Olivier; Shaw, Leslie M; Eidelberg, David; Bower, Pam; Cummings, Jeffrey L; Abler, Victor; Biedenharn, Judy; Bitan, Gal; Brooks, David J; Brundin, Patrik; Fernandez, Hubert; Fortier, Philip; Freeman, Roy; Gasser, Thomas; Hewitt, Art; Höglinger, Günter U; Huentelman, Matt J; Jensen, Poul H; Jeromin, Andreas; Kang, Un Jung; Kaufmann, Horacio; Kellerman, Lawrence; Khurana, Vikram; Klockgether, Thomas; Kim, Woojin Scott; Langer, Carol; LeWitt, Peter; Masliah, Eliezer; Meissner, Wassilios; Melki, Ronald; Ostrowitzki, Susanne; Piantadosi, Steven; Poewe, Werner; Robertson, David; Roemer, Cyndi; Schenk, Dale; Schlossmacher, Michael; Schmahmann, Jeremy D; Seppi, Klaus; Shih, Lily; Siderowf, Andrew; Stebbins, Glenn T; Stefanova, Nadia; Tsuji, Shoji; Sutton, Sharon; Zhang, Jing

    2018-01-09

    Multiple system atrophy (MSA) is a rare neurodegenerative disorder with substantial knowledge gaps despite recent gains in basic and clinical research. In order to make further advances, concerted international collaboration is vital. In 2014, an international meeting involving leaders in the field and MSA advocacy groups was convened in Las Vegas, Nevada, to identify critical research areas where consensus and progress was needed to improve understanding, diagnosis, and treatment of the disease. Eight topic areas were defined: pathogenesis, preclinical modeling, target identification, endophenotyping, clinical measures, imaging biomarkers, nonimaging biomarkers, treatments/trial designs, and patient advocacy. For each topic area, an expert served as a working group chair and each working group developed priority-ranked research recommendations with associated timelines and pathways to reach the intended goals. In this report, each groups' recommendations are provided. Copyright © 2017 American Academy of Neurology.

  16. Do drug treatment variables predict cognitive performance in multidrug-treated opioid-dependent patients? A regression analysis study

    PubMed Central

    2012-01-01

    Background Cognitive deficits and multiple psychoactive drug regimens are both common in patients treated for opioid-dependence. Therefore, we examined whether the cognitive performance of patients in opioid-substitution treatment (OST) is associated with their drug treatment variables. Methods Opioid-dependent patients (N = 104) who were treated either with buprenorphine or methadone (n = 52 in both groups) were given attention, working memory, verbal, and visual memory tests after they had been a minimum of six months in treatment. Group-wise results were analysed by analysis of variance. Predictors of cognitive performance were examined by hierarchical regression analysis. Results Buprenorphine-treated patients performed statistically significantly better in a simple reaction time test than methadone-treated ones. No other significant differences between groups in cognitive performance were found. In each OST drug group, approximately 10% of the attention performance could be predicted by drug treatment variables. Use of benzodiazepine medication predicted about 10% of performance variance in working memory. Treatment with more than one other psychoactive drug (than opioid or BZD) and frequent substance abuse during the past month predicted about 20% of verbal memory performance. Conclusions Although this study does not prove a causal relationship between multiple prescription drug use and poor cognitive functioning, the results are relevant for psychosocial recovery, vocational rehabilitation, and psychological treatment of OST patients. Especially for patients with BZD treatment, other treatment options should be actively sought. PMID:23121989

  17. Quality of Diagnosis and Treatment Plans After Using the 'Diagnostic Guideline for Anxiety and Challenging Behaviours' in People with Intellectual Disabilities: A Comparative Multiple Case Study Design.

    PubMed

    Pruijssers, Addy; van Meijel, Berno; Maaskant, Marian; Keeman, Noortje; van Achterberg, Theo

    2016-07-01

    People with intellectual disabilities often have a multitude of concurrent problems due to the combination of cognitive impairments, psychiatric disorders (particularly anxiety) and related challenging behaviours. Diagnoses in people with intellectual disabilities are complicated. This study evaluates the quality of the diagnoses and treatment plans after using a guideline that was developed to support professionals in their diagnostic tasks. A comparative multiple case study with an experimental and control condition, applying deductive analyses of diagnoses and treatment plans. The analyses revealed that the number of diagnostic statements and planned treatment actions in the experimental group was significantly larger and more differentiated than in the control condition. In the control group, consequential harm and protective factors were hardly mentioned in diagnoses and treatment plans. Working with the 'Diagnostic Guideline for Anxiety and CB' leads to improved diagnoses and treatment plans compared with care as usual. © 2015 John Wiley & Sons Ltd.

  18. Clinical effectiveness of multiple-drug injection treatment in unruptured ectopic pregnancies: a retrospective study.

    PubMed

    Dai, Quan; Wang, Lu-Lu; Shao, Xiao-Hui; Wang, Si-Ming; Dong, Xiao-Qiu

    2012-10-01

    To study the effect of local interventional treatment of unruptured ectopic pregnancies with multiple-drug injection guided by color Doppler sonography. In this retrospective analysis, 49 patients with an unruptured ectopic pregnancy were treated with two different local injection methods administered under sonographic guidance. The patients were divided into single-drug (n = 23) and multiple-drug (n = 26) injection groups, and they received a locally administered injection of methotrexate alone or a combination including methotrexate, hemocoagulase, antibiotics, and anti-inflammatory drugs, respectively. Overall, local injection treatment was successful in 44 patients. The 5 patients with failed treatment underwent laparotomy about 1 week after single-drug injection. Serum β-human chorionic gonadotropin (β-hCG ) levels, ectopic pregnancy mass sizes, blood flow at various points after treatment, the incidence of pelvic bleeding, and the time for serum β-hCG levels to return to normal and the mass to resolve were analyzed in the remaining 44 patients. Single-drug treatment was successful in 18 patients; 10 of 23 had low to moderate pelvic bleeding after treatment, and 5 were referred for surgery. All 26 patients were successfully treated by multiple-drug injection. Only 2 patients had a small amount of pelvic bleeding. Differences between groups were statistically significant (P < .05) for surgery rates, the incidence of pelvic bleeding, transient increases in serum β-hCG levels, mean days to normal β-hCG levels, mean days of mass resolution, and mean mass diameters 1 to 6 weeks after treatment. Local multiple-drug injection under color Doppler guidance is a new, safe, and effective method for treating unruptured ectopic pregnancies. It accelerates the serum β-hCG decline and facilitates mass resolution. This regimen is associated with a very low rate of pelvic bleeding, improves the success rate of conservative treatment, and, therefore, has value as an important clinical application.

  19. Monitoring interferon β treatment response with magnetic resonance spectroscopy in relapsing remitting multiple sclerosis.

    PubMed

    Yetkin, Mehmet Fatih; Mirza, Meral; Dönmez, Halil

    2016-09-01

    The aim of this study is to compare the white matter of multiple sclerosis (MS) patients with healthy controls and to monitor the response to the treatment with magnetic resonance spectroscopy (MRS).Fifteen healthy controls and 36 recently diagnosed MS patients never treated with interferon β were included in this study. In the patient group, MRS was performed before treatment, at 6th and 12th month after the initiation of treatment and once in control group. Patient group was divided into 3 interferon groups randomly. Physical examination findings were recorded as Expanded Disability Status Scale scores before treatment, at 6th and 12th month of interferon treatment.At the end of 1 year follow up, 26 of 36 patients completed the study. In patients' white matter lesions, N-acetylaspartate/creatine (NAA/Cr) ratios were lower than control group's white matters. NAA/Cr ratios were higher in control group's white matter than patient's normal appearing white matter but this difference was not statistically significant. There was no difference in choline/creatine (Cho/Cr) ratios between 2 groups. In follow-up period, NAA/Cr and Cho/Cr ratios obtained from patients' white matter lesions and normal appearing white matter did not change statistically.This study showed that in MS patients' white matters, especially in white matter lesions, neuron viability is reduced compared with healthy controls' normal white matter; and in the patients treated with interferon β NAA/Cr ratios remained stable. These stable levels of metabolite ratios in the patients who received interferon β therapy can be explained with either the shortness of the follow-up period post-treatment or may reflect a positive effect of the beta interferon therapy on the progress of MS.

  20. Experimental problem solving: An instructional improvement field experiment

    NASA Astrophysics Data System (ADS)

    Ross, John A.; Maynes, Florence J.

    An instructional program based on expert-novice differences in experimental problem-solving performance was taught to grade 6 students (N = 265). Classes of students were randomly assigned to conditions in a delayed treatment design. Performance was assessed with multiple-choice and open-ended measures of specific transfer. Between group comparisons using pretest scores as a covariate showed that treatment condition students consistently outperformed controls; similar results were revealed in the within group comparisons. The achievement of the early treatment group did not decline in tests administered one month after the posttest.

  1. The Outcome of Multiple Slit on Plaque with Plication Technique for the Treatment of Peyronie's Disease

    PubMed Central

    Shin, Su Hwan; Jeong, Hyeong Guk; Park, Jong Jin; Chae, Ji Yun; Kim, Jong Wook; Oh, Mi Mi; Park, Hong Seok; Kim, Je Jong

    2016-01-01

    Purpose To evaluate the postoperative outcome of the multiple slit on plaque plication technique for the treatment of Peyronie's disease. Materials and Methods We retrospectively evaluated 22 patients who underwent plaque incision with penile plication for the surgical treatment of Peyronie's disease, who had failed medical treatment between 2009 and 2014. Patients were grouped by preoperative degree of penile curvature into Group I: mild (n=5, 22.7%), Group II: moderate (n=11, 50.0%), and Group III: severe (n=6, 27.3%). After a thorough review of the medical records, we evaluated (a) the correction of the curvature; (b) sexual function; and (c) any penile shortening or other complications. Results The mean postoperative follow-up period was 39 months. Complete correction of the curvature was attained in 21 patients (95.5%). As an inevitable complication, minimal penile shortening (<1.5 cm) was reported by 14 patients (82.4%) but did not adversely affect sexual intercourse (0%), and all patients found the extent of penile shortening to be acceptable. Nineteen patients had good erectile function (International Index of Erectile Function >21). The most frequent complication was subcutaneous penile edema in three patients (13.6%), which was resolved within about 3 months following surgery. Conclusions As a modified technique, multiple slit on plaque with plication is a simple, minimally-invasive and effective technique for correcting penile curvature regardless of curvature severity. The degree of penile curvature does not significantly predict the amount of penile length loss. PMID:27169125

  2. Effects of nonfiction guided interactive read-alouds and think-alouds on fourth grader's depth of content area science vocabulary knowledge and comprehension

    NASA Astrophysics Data System (ADS)

    Hanna, Tania Tamara

    Effects of nonfiction guided interactive read-alouds and think-alouds as a supplement to basal science textbooks on three vocabulary measures, definitions, examples, and characteristics, and one multiple-choice comprehension measure were assessed for 127 fourth graders over three time periods: pretest, posttest, and a 2-week delayed posttest. Two of three fourth-grade elementary science teachers implemented a series of 12 content-enhanced guided interactive scripted lessons. Two of these teachers implemented two treatments each. The first condition employed basal science textbooks as the text for guided interactive read-alouds and think-alouds while the second treatment employed basal science textbooks in conjunction with nonfiction text sets as the texts for guided interactive read-alouds and think-alouds. The third teacher, guided by traditional lesson plans, provided students with silent independent reading instruction using basal science textbooks. Multivariate analyses of variance and analyses of variance tests showed that mean scores for both treatment groups significantly improved on definitions and characteristics measures at posttest and either stabilized or slightly declined at delayed posttest. The treatment-plus group lost considerably on the examples posttest measure. The treatment group improved mean scores on the examples posttest measure, outperforming the treatment-plus group and the control group. Alternately, the control group significantly improved on the delayed posttest examples measure. Additionally, the two groups implementing guided interactive read-alouds and think-alouds performed better than the independent reading group on multiple-choice comprehension measures at posttest and sustained those gains 2 weeks later on delayed posttests. Findings maintain the incremental nature of vocabulary acquisition and development research and emphasize the roles of listening and speaking as critical features for integrating vocabulary into long-term memory.

  3. Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

    PubMed

    Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

    2013-11-01

    To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

  4. Exposure Plus Response-Prevention Treatment of Bulimia Nervosa.

    ERIC Educational Resources Information Center

    Leitenberg, Harold; And Others

    1988-01-01

    Evaluated exposure plus response-prevention treatment of bulimia nervosa among 47 women. Subjects were assigned to either exposure plus response-prevention in one setting, exposure plus response-prevention in multiple settings, cognitive-behavioral therapy, or waiting-list control conditions. Found three treatment groups improved significantly on…

  5. Polycythaemia: an unusual presentation of multiple myeloma.

    PubMed

    Hutchison, Elaine J; Taverna, Josephine A; Yu, Qi; Yeager, Andrew M

    2016-09-20

    In contrast to anaemia, polycythaemia is a distinctly uncommon finding in patients with multiple myeloma. We describe the presence of otherwise unexplained polycythaemia in a 57-year-old Caucasian man who was found to have IgG κ multiple myeloma. After treatment of myeloma, the polycythaemia resolved. We reviewed previous reports of polycythaemia associated with multiple myeloma and discuss potential pathophysiological mechanisms that link these 2 conditions. 2016 BMJ Publishing Group Ltd.

  6. Endodontic flare-ups: comparison of incidence between single and multiple visits procedures in patients attending a Nigerian teaching hospital.

    PubMed

    Oginni, Ao; Udoye, C I

    2004-12-01

    The present study was performed to compare the incidence of endodontic flare ups in single with multiple visits treatment procedures, to establish the relationship between pre-operative and post obturation pain in patients attending for endodontic therapy in a Nigerian teaching Hospital. Patients were randomly assigned to either single visit or multiple visits group. Data collected at root canal treatment appointment and recall visits (1st, 7th and 30th day post obturation) include pulp vitality status, the presence or absence of pre-operative pain, presence and degree of post obturation pain. Presence of endodontic flare-ups (defined as either patient's report of pain not controlled with over the counter medication and or increasing swelling). The compiled data were analyzed using chi-square where applicable. P level < 0.05 was taken as significant. Ten endodontic flare-ups (8.1 %) were recorded in the multiple visits group compared to 19 (18,3%) flare-ups for the single visit group, P = 0.02. For both single and multiple visits procedures, there were statistically significant correlations between pre operative and post obturation pain (P = 0.002 and P = 0.0004 respectively). Teeth with vital pulps reported the lowest frequency of post obturation pain (48.8%), while those with non vital pulps were found to have the highest frequency oh post obturation pain (50,3%), P = 0.9. Although the present study reported higher incidences for post obturation pain and flare-ups following the single visit procedures, single visit endodontic therapy has been shown to be a safe and effective alternative to multiple visits treatment.

  7. [The application of high-frequency and iTBS transcranial magnetic stimulation for the treatment of spasticity in the patients presenting with secondary progressive multiple sclerosis].

    PubMed

    Korzhova, J E; Chervyakov, A V; Poydasheva, A G; Kochergin, I A; Peresedova, A V; Zakharova, M N; Suponeva, N A; Chernikova, L A; Piradov, M A

    Spasticity is considered to be a common manifestation of multiple sclerosis. Muscle relaxants are not sufficiently effective; more than that, some of them often cause a variety of adverse reactions. Transcranial magnetic stimulation (TMS) can be a promising new tool for the treatment of spasticity. The objective of the present study was to compare the effectiveness of the two TMS protocols: rhythmic (high-frequency) TMS (rTMS) and stimulation with the theta bursts (iTBS) in terms of their ability to reduce spasticity in the patients presenting with multiple sclerosis. Twenty two patients with secondary-progressive multiple sclerosis were pseudo-randomized into two groups: those in the first (high-frequency) group received the treatment with the use of rTMS therapy at a frequency of 10 Hz; the patients of the second group, underwent stimulation with the theta bursts (iTBS). All the patients received 10 sessions of either stimulation applied to the primary motor area (M1) of both legs. The effectiveness of TMS protocols was evaluated before therapy and after 10 sessions of stimulation based on the Modified Ashworth scale (MAS), the expanded disability status scale (EDSS), and the Kurtzke functional scale (Kfs). In addition, the patients were interviewed before treatment, after 10 rTMS sessions, immediately after and within 2 and 12 weeks after the completion of the treatment using questionnaires for the evaluation of spasticity (SESS) , fatigue, and dysfunction of the pelvic organs (severity of defecation and urination disorders), fatigue. The study has demonstrated a significant reduction in spasticity in the patients of both groups at the end of the TMS protocol based on the MAS scale. There was no significant difference between the outcomes of the two protocols. Both had positive effect on the concomitant «non-motor» symptoms (fatigue, dysfunction of the pelvic organs). High-frequency transcranial magnetic stimulation (10 sessions of rTMS therapy at a frequency of 10 Hz) and stimulation with the theta-bursts applied to the M1 area in both legs can be an effective alternative treatment of spasticity in the patients with secondary-progressive multiple sclerosis. Further research is needed to detect more accurately the differences between the outcomes of the two stimulation protocols and the development of indications for their application on an individual basis.

  8. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial

    PubMed Central

    Gandolfi, Marialuisa; Geroin, Christian; Picelli, Alessandro; Munari, Daniele; Waldner, Andreas; Tamburin, Stefano; Marchioretto, Fabio; Smania, Nicola

    2014-01-01

    Background: Extensive research on both healthy subjects and patients with central nervous damage has elucidated a crucial role of postural adjustment reactions and central sensory integration processes in generating and “shaping” locomotor function, respectively. Whether robotic-assisted gait devices might improve these functions in Multiple sclerosis (MS) patients is not fully investigated in literature. Purpose: The aim of this study was to compare the effectiveness of end-effector robot-assisted gait training (RAGT) and sensory integration balance training (SIBT) in improving walking and balance performance in patients with MS. Methods: Twenty-two patients with MS (EDSS: 1.5–6.5) were randomly assigned to two groups. The RAGT group (n = 12) underwent end-effector system training. The SIBT group (n = 10) underwent specific balance exercises. Each patient received twelve 50-min treatment sessions (2 days/week). A blinded rater evaluated patients before and after treatment as well as 1 month post treatment. Primary outcomes were walking speed and Berg Balance Scale. Secondary outcomes were the Activities-specific Balance Confidence Scale, Sensory Organization Balance Test, Stabilometric Assessment, Fatigue Severity Scale, cadence, step length, single and double support time, Multiple Sclerosis Quality of Life-54. Results: Between groups comparisons showed no significant differences on primary and secondary outcome measures over time. Within group comparisons showed significant improvements in both groups on the Berg Balance Scale (P = 0.001). Changes approaching significance were found on gait speed (P = 0.07) only in the RAGT group. Significant changes in balance task-related domains during standing and walking conditions were found in the SIBT group. Conclusion: Balance disorders in patients with MS may be ameliorated by RAGT and by SIBT. PMID:24904361

  9. [Outcomes of treatment of chemotherapy drugs different manufacturers tuberculosis patients with multiple drug resistance].

    PubMed

    2014-09-01

    The article is devoted to studying the effectiveness of treatment of tuberculosis (TB) patients with multidrug-resistant TB drugs 2 number of different manufacturers. To assess the effectiveness of treatment of second-line drugs were taken to study two groups of patients: Group 1 - 164 patients who received anti-TB drugs from the Global Fund and Group 2 174 patients who received anti-TB drugs for the national program. Comparative evaluation showed high efficiency second-line drugs from the Global Fund, as evidenced by the high level of 95,8 % abacillation in a short time in this patient group.

  10. Matching with Multiple Control Groups with Adjustment for Group Differences

    ERIC Educational Resources Information Center

    Stuart, Elizabeth A.; Rubin, Donald B.

    2008-01-01

    When estimating causal effects from observational data, it is desirable to approximate a randomized experiment as closely as possible. This goal can often be achieved by choosing a subsample from the original control group that matches the treatment group on the distribution of the observed covariates. However, sometimes the original control group…

  11. Group Therapy for Abused and Neglected Youth: Therapeutic and Child Advocacy Challenges

    ERIC Educational Resources Information Center

    Wanlass, Janine; Moreno, J. Kelly; Thomson, Hannah M.

    2006-01-01

    Although group therapy for abused and neglected youth is a viable and efficacious treatment option, facilitation is challenging. Group leaders must contain intense affect, manage multiple transferences, and advocate for their clients within the larger social welfare system. Using a case study of a group for sexually abused girls, this paper…

  12. Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study.

    PubMed

    Calabresi, Peter A; Kieseier, Bernd C; Arnold, Douglas L; Balcer, Laura J; Boyko, Alexey; Pelletier, Jean; Liu, Shifang; Zhu, Ying; Seddighzadeh, Ali; Hung, Serena; Deykin, Aaron

    2014-07-01

    Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial, a study of patients with relapsing-remitting multiple sclerosis. We did this 2-year, double-blind, parallel group, phase 3 study, with a placebo-controlled design for the first 48 weeks, at 183 sites in 26 countries. Patients with relapsing-remitting multiple sclerosis (age 18-65 years, with Expanded Disability Status Scale score ≤5) were randomly assigned (1:1:1) via an interactive voice response or web system, and stratified by site, to placebo or subcutaneous peginterferon beta-1a 125 μg once every 2 weeks or every 4 weeks. The primary endpoint was annualised relapse rate at 48 weeks. This trial is registered with ClinicalTrials.gov, number NCT00906399. We screened 1936 patients and enrolled 1516, of whom 1512 were randomly assigned (500 to placebo, 512 to peginterferon every 2 weeks, 500 to peginterferon every 4 weeks); 1332 (88%) patients completed 48 weeks of treatment. Adjusted annualised relapse rates were 0·397 (95% CI 0·328-0·481) in the placebo group versus 0·256 (0·206-0·318) in the every 2 weeks group and 0·288 (0·234-0·355) in the every 4 weeks group (rate ratio for every 2 weeks group 0·644, 95% CI 0·500-0·831, p=0·0007; rate ratio for the every 4 weeks group 0·725, 95% CI 0·565-0·930, p=0·0114). 417 (83%) patients taking placebo, 481 (94%) patients taking peginterferon every 2 weeks, and 472 (94%) patients taking peginterferon every 4 weeks reported adverse events including relapses. The most common adverse events associated with peginterferon beta-1a were injection site reactions, influenza-like symptoms, pyrexia, and headache. 76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common. After 48 weeks, peginterferon beta-1a significantly reduced relapse rate compared with placebo. The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments. Biogen Idec. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. A Comparative Study of Liquid Nitrogen Cryotherapy as Monotherapy versus in Combination with Podophyllin in the Treatment of Condyloma Acuminata.

    PubMed

    Sharma, Nidhi; Sharma, Sanjeev; Singhal, Chetna

    2017-03-01

    Condyloma Acuminata (CA) is a common viral sexually transmitted disease. Although various treatment modalities are available for treating CA, but none of them can achieve 100% response rate. In a search for better response rate and less recurrence rate, the combination of cytotoxic agent Podophyllin with ablative liquid nitrogen cryotherapy was evaluated over cryotherapy alone. To evaluate the synergistic effect of Podophyllin as a chemotherapeutic adjunct to an ablative therapy of liquid nitrogen cryotherapy versus liquid nitrogen cryotherapy alone in the treatment of CA. Sixty patients with multiple CA were randomly assigned to two groups in the study. Thirty patients in group A received double freeze thaw cycle of 25 seconds of liquid nitrogen cryotherapy. Thirty patients in Group B were subjected to liquid nitrogen cryotherapy in a similar manner followed by application of not more than 0.5 ml of 25% Podophyllin solution. All patients were followed up at 1, 4, 8, 12 and 24 weeks after the treatment to monitor the response to therapy and evaluation for any recurrence. When the number of unresponsive lesions were more than 30% of original lesions at 4 weeks follow-up, then the whole procedure was repeated again. The complete response rate and the recurrence rate in the Group B in our study were comparable to Group A as the difference was statistically insignificant. But the differentiating point was that the similar results were obtained in Group B with an average1.2 sessions per patient in comparison to an average of 1.67 sessions per patient in Group A. Cryotherapy represents a simple, safe and effective regimen for the treatment of multiple CA which in combination with Podophyllin is even more effective as a single session procedure; thereby shortening the treatment regimen.

  14. Neuromuscular taping versus sham therapy on muscular strength and motor performance in multiple sclerosis patients.

    PubMed

    Costantino, Cosimo; Pedrini, Martina Francesca; Licari, Oriana

    2016-01-01

    Purpose of this study is to evaluate differences in leg muscles strength and motor performance between neuromuscular taping (NT) and sham tape groups. Relapsing-remitting (RR) multiple sclerosis (MS) patients were recruited and randomly assigned to NT or sham tape groups. All patients underwent the treatment 5 times at 5-d intervals. They were submitted to a 6-minute walk test and isokinetic test (peak torque) at the beginning (T0), at the end (T1) and 2 months after the end of the treatment (T2). Forty MS patients (38 F; 2 M; mean age 45.5 ± 6.5 years) were assigned to NT group (n = 20) and to sham tape group (n = 20). Delta Peak Torque T1-T0 and T2-T0 between two groups were statistically significant in quadriceps (p = 0.007; 0.000) and hamstrings (p = 0.011; 0.007). The difference between the two groups according to 6-minute walk test was not statistically significant but in NT group it was noticed an increasing trend about the distance run. In this single-blind randomized controlled trial, NT seemed to increase strength in leg muscles, compared to a sham device, in RR MS patients. Further studies are needed to consider this therapy as a complement to classic physical therapy. Neuromuscular taping (NT) in multiple sclerosis: NT is well tolerated by multiple sclerosis patients and should be a complement to classic physical therapy. This technique normalizes muscular function, strengthens weakened muscles and assists the postural alignment.

  15. The effect of pelvic floor muscle training alone or in combination with electrostimulation in the treatment of sexual dysfunction in women with multiple sclerosis.

    PubMed

    Lúcio, A C; D'Ancona, C A L; Lopes, M H B M; Perissinotto, M C; Damasceno, B P

    2014-11-01

    Sexual dysfunction (SD) affects up to 80% of multiple sclerosis (MS) patients and pelvic floor muscles (PFMs) play an important role in the sexual function of these patients. The objective of this paper is to evaluate the impact of a rehabilitation program to treat lower urinary tract symptoms on SD of women with MS. Thirty MS women were randomly allocated to one of three groups: pelvic floor muscle training (PFMT) with electromyographic (EMG) biofeedback and sham neuromuscular electrostimulation (NMES) (Group I), PFMT with EMG biofeedback and intravaginal NMES (Group II), and PFMT with EMG biofeedback and transcutaneous tibial nerve stimulation (TTNS) (Group III). Assessments, before and after the treatment, included: PFM function, PFM tone, flexibility of the vaginal opening and ability to relax the PFMs, and the Female Sexual Function Index (FSFI) questionnaire. After treatment, all groups showed improvements in all domains of the PERFECT scheme. PFM tone and flexibility of the vaginal opening was lower after the intervention only for Group II. All groups improved in arousal, lubrication, satisfaction and total score domains of the FSFI questionnaire. This study indicates that PFMT alone or in combination with intravaginal NMES or TTNS contributes to the improvement of SD. © The Author(s), 2014.

  16. Evaluation of the Impact of Cognitive Training on Quality of Life in Patients with Multiple Sclerosis.

    PubMed

    Grasso, Maria Grazia; Broccoli, Marco; Casillo, Paolo; Catani, Sheila; Pace, Luca; Pompa, Alessandra; Rizzi, Francesco; Troisi, Elio

    2017-01-01

    The aim of this study was to evaluate the effectiveness of cognitive rehabilitation in a group of multiple sclerosis (MS) patients. Thirty-four patients were included in this study and randomly allocated either to treatment with multidisciplinary rehabilitation plus cognitive training or to treatment with multidisciplinary rehabilitation alone. After 3 months of cognitive treatment, the patients assigned to the rehabilitation plus cognitive training group displayed an improvement in the cognitive test of executive function and a marked improvement in quality of life (QoL). The patients treated with multidisciplinary rehabilitation without cognitive training improved in the physical composite score alone. Both groups of patients displayed an improvement in depression, though the improvement was confirmed at the 6-month follow-up examination (p = 0.036) only in patients treated with multidisciplinary rehabilitation plus cognitive training. Our results indicate that the multidisciplinary rehabilitation treatment is the best approach to treat MS. The specific effect of each treatment needs to be assessed to be able to determine its role within a multidisciplinary approach. Cognitive rehabilitation is an important aspect of this multidisciplinary approach insofar as it may improve the QoL of MS people. © 2017 S. Karger AG, Basel.

  17. [The efficiency of emergency therapy in patients with head-brain, multiple injury. Quality assurance in emergency medicine].

    PubMed

    Schüttler, J; Schmitz, B; Bartsch, A C; Fischer, M

    1995-12-01

    For cardio-pulmonary resuscitation there are standardized treatment concepts, but there have been few prospective investigations examining the efficacy of prehospital advanced trauma life support and its effect on the outcome in patients with severe head injury and multiple trauma treated within the German emergency system. The results of this study underline the importance of intensive prehospital treatment and highlight some problems that should be taken into account in future in the training of emergency physicians. METHODS. A total of 179 patients with cerebral trauma were investigated. Data obtained included demographic and logistic data of the patients and the emergency physicians, diagnoses and treatment at the scene of the accident and state of the patient on admission in each case. Having divided the patients into three groups by severity of the trauma, we distinguished between sufficient and insufficient treatment and assessed infusion therapy, ventilatory support, positioning and immobilization, and analgesic and sedative therapy. For statistical analysis of the data we used chi 2-test and Fisher's exact test. P < 0.05 was considered significant. RESULTS. There were 102 patients who had sustained a cerebral trauma without other life-threatening lesions (score 1), 40 with multiple trauma (score 2) and 37 with multiple trauma (score 3). On average 2.4 IV lines were established and the patients received 1186 +/- 765 cc of crystalloid in addition to 801 +/- 411 cc of colloid fluids. In all groups, patients who received adequate infusion therapy had a better outcome; even in the group with score 1 significantly fewer had a fatal outcome. In all, 167 (93%) patients had endotracheal tubes placed, and in 150 cases (84%) ventilatory therapy was considered sufficient. The proportion of score 1 patients with sufficient ventilatory support who had a fatal outcome was significantly lower than that in the group with insufficient treatment. In patients with multiple trauma we could not separate the benefits of sufficient respiratory therapy and infusion therapy. In only 54% of the cases a vacuum mattress was used and in only 41% the patients were positioned with the upper part of the body elevated by 30 degrees. These were 28 patients (16%) who received neither analgesics nor sedatives. Regardless of the quality of prehospital treatment of isolated head injury, a Glasgow Coma Scale (GCS) score lower than 5 involved a very high mortality and all patients with a GCS score of 9 or more survived. In the group with GCS scores between 5 and 8, however, significantly more of the patients who received adequate treatment survived (82.5% vs 40%). CONCLUSIONS. The present study confirms that sufficient advanced trauma life support can improve the outcome of trauma victims with cerebral trauma. Adequate infusion and respiratory therapy reduce the mortality among such patients significantly. In patients with multiple trauma a clear positive effect of generous infusion therapy also is evident. The clearest effect of sufficient prehospital treatment is seen in patients with isolated cerebral trauma and a GCS score between 5 and 8. These results demonstrate the importance of advanced trauma life support and show emphatically that the so-called scoop-and-run strategy should be abandoned when resources are available for extended preclinical emergency treatment. On the other hand, we detected some problem areas in the prehospital treatment of trauma victims, such as positioning, immobilization and drug therapy with analgesics and sedatives. These findings allow us to pinpoint specific points that should be stressed in the training of emergency physicians and paramedics.

  18. A new class of nitrosoureas. 4. Synthesis and antitumor activity of disaccharide derivatives of 3,3-disubstituted 1-(2-chloroethyl)-1-nitrosoureas.

    PubMed

    Tsujihara, K; Ozeki, M; Morikawa, T; Kawamori, M; Akaike, Y; Arai, Y

    1982-04-01

    A series of 33 N-(2-chloroethyl)-N-nitrosocarbamoyl derivatives of N-substituted glycosylamines has been prepared and tested for antitumor activities. The compounds were obtained by reaction of glycosylamines with isocyanate, followed by nitrosation with N2O4. Structure-activity relationships of these trisubstituted nitrosoureas were investigated by varying the N-substituents and disaccharide groups and by comparing them with the corresponding disubstituted analogues. A large number of the nitrosoureas bearing a maltosyl group exhibited strong antitumor activities against leukemia L1210 and Ehrlich ascites carcinoma, and 60-day survivors against leukemia L1210 were found at the optimal dose for these derivatives. In contrast, the lactosyl and the melibiosyl derivatives were almost inactive. The most interesting compound in this series, the 3-isobutyl-3-maltosyl derivative (37), was tested against leukemia L1210 by single and multiple treatment. Its therapeutic ratio (96.3) obtained by multiple treatment is 3 times larger than that (31.5) obtained by single treatment, suggesting a possible clinical utility of 37 by multiple treatment. The favorable effect of a maltosyl moiety in this class of compounds is discussed.

  19. What Infant Memory Tells Us about Infantile Amnesia: Long-Term Recall and Deferred Imitation

    PubMed Central

    Meltzoff, Andrew N.

    2013-01-01

    Long-term recall memory was assessed using a nonverbal method requiring subjects to reenact a past event from memory (deferred imitation). A large sample of infants (N = 192), evenly divided between 14- and 16-months old, was tested across two experiments. A delay of 2 months was used in Experiment 1 and a delay of 4 months in Experiment 2. In both experiments two treatment groups were used, In one treatment group, motor practice (immediate imitation) was allowed before the delay was imposed; in the other group, subjects were prevented from motor practice before the delay. Age-matched control groups were used lo assess the spontaneous production of the target acts in the absence of exposure to the model in both experiments. The results demonstrated significant deferred imitation for both treatment groups at both delay intervals, and moreover showed that infants retained and imitated multiple acts. These findings suggest that infants have a nonverbal declarative memory system that supports the recall of past events across long-term delays. The implications of these findings for the multiple memory system debate in cognitive science and neuroscience and for theories of infantile amnesia are considered. PMID:7622990

  20. Examining Predictors of Group Leader Self-Efficacy for Preservice School Counselors

    ERIC Educational Resources Information Center

    Springer, Sarah I.

    2016-01-01

    Group counseling is an important treatment modality used to support clients in a variety of therapeutic settings. This article highlights the results of an exploratory study that examined site supervisory factors that predicted group leader self-efficacy for preservice school counselors. Results of multiple regression analyses suggest meaningful…

  1. Addressing astronomy misconceptions and achieving national science standards utilizing aspects of multiple intelligences theory in the classroom and the planetarium

    NASA Astrophysics Data System (ADS)

    Sarrazine, Angela Renee

    The purpose of this study was to incorporate multiple intelligences techniques in both a classroom and planetarium setting to create a significant increase in student learning about the moon and lunar phases. Utilizing a free-response questionnaire and a 25 item multiple choice pre-test/post-test design, this study identified middle school students' misconceptions and measured increases in student learning about the moon and lunar phases. The study spanned two semesters and contained six treatment groups which consisted of both single and multiple interventions. One group only attended the planetarium program. Two groups attended one of two classes a week prior to the planetarium program, and two groups attended one of two classes a week after the planetarium program. The most rigorous treatment group attended a class both a week before and after the planetarium program. Utilizing Rasch analysis techniques and parametric statistical tests, all six groups exhibited statistically significant gains in knowledge at the 0.05 level. There were no significant differences between students who attended only a planetarium program versus a single classroom program. Also, subjects who attended either a pre-planetarium class or a post- planetarium class did not show a statistically significant gain over the planetarium only situation. Equivalent effects on student learning were exhibited by the pre-planetarium class groups and post-planetarium class groups. Therefore, it was determined that the placement of the second intervention does not have a significant impact on student learning. However, a decrease in learning was observed with the addition of a third intervention. Further instruction and testing appeared to hinder student learning. This is perhaps an effect of subject fatigue.

  2. Implications of clinical trial design on sample size requirements.

    PubMed

    Leon, Andrew C

    2008-07-01

    The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two particularly relevant aspects of such a design often receive insufficient attention in an RCT. Multiple outcomes inflate type I error, and an unreliable assessment process introduces bias and reduces statistical power. Here we describe how both unreliability and multiple outcomes can increase the study costs and duration and reduce the feasibility of the study. The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity.

  3. Impact of non-anticoagulant therapy on patients with sepsis-induced disseminated intravascular coagulation: A multicenter, case-control study.

    PubMed

    Kudo, Daisuke; Hayakawa, Mineji; Ono, Kota; Yamakawa, Kazuma

    2018-03-01

    Anticoagulant therapy for patients with sepsis is not recommended in the latest Surviving Sepsis Campaign guidelines, and non-anticoagulant therapy is the global standard treatment approach at present. We aimed at elucidating the effect of non-anticoagulant therapy on patients with sepsis-induced disseminated intravascular coagulation (DIC), as evidence on this topic has remained inconclusive. Data from 3195 consecutive adult patients admitted to 42 intensive care units for the treatment of severe sepsis were retrospectively analyzed via propensity score analyses with and without multiple imputation. The primary outcome was in-hospital all-cause mortality. Among 1784 patients with sepsis-induced DIC, 745 (41.8%) were not treated with anticoagulants. The inverse probability of treatment-weighted (with and without multiple imputation) and quintile-stratified propensity score analyses (without multiple imputation) indicated a significant association between non-anticoagulant therapy and higher in-hospital all-cause mortality (odds ratio [95% confidence interval]: 1.59 [1.19-2.12], 1.32 [1.02-1.81], and 1.32 [1.03-1.69], respectively). However, quintile-stratified propensity score analyses with multiple imputation and propensity score matching analysis with and without multiple imputation did not show this association. Survival duration was not significantly different between patients in the propensity score-matched non-anticoagulant therapy group and those in the anticoagulant therapy group (Cox regression analysis with and without multiple imputation: hazard ratio [95% confidence interval]: 1.26 [1.00-1.60] and 1.22 [0.93-1.59], respectively). It remains controversial if non-anticoagulant therapy is harmful, equivalent, or beneficial compared with anticoagulant therapy in the treatment of patients with sepsis-induced DIC. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Using impedance cardiography to detect subclinical cardiovascular disease in women with multiple risk factors: a pilot study.

    PubMed

    Demarzo, Arthur P

    2009-01-01

    Early detection of cardiovascular disease (CVD) could initiate appropriate treatment and prevent progression. This study used impedance cardiography (ICG) waveform analysis with postural change to detect functional CVD in women older than 40 years with no history of CVD and >or=2 of the following risk factors: cigarette smoking, poor diet, physical inactivity, central adiposity, family history of premature CVD, hypertension, and dyslipidemia. A study group of 32 women underwent ICG in standing and supine positions. An age-matched control group had 20 women with an active lifestyle, no risk factors, and no history of CVD. All women in the control group had normal ICG data. All women in the study group had some abnormal ICG data, with 28 (87.5%) having multiple ICG abnormalities. ICG data indicated that 13 (40.6%) had ventricular dysfunction, 14 (43.8%) had high vascular resistive load, and 30 (93.8%) had elevated vascular pulsatile load. The data suggest that subclinical CVD, detectable by ICG, is prevalent in women older than 40 years with multiple risk factors. Abnormal ICG results could expedite the initiation of customized treatment as part of a preventive approach to CVD. (c) 2009 Wiley Periodicals, Inc.

  5. The DSM-IV nosology of chronic pain: a comparison of pain disorder and multiple somatization syndrome.

    PubMed

    Hiller, W; Heuser, J; Fichter, M M

    2000-01-01

    This study evaluates the classification of pain from the perspective of the DSM-IV system. Of 60 in-patients with long-standing and disabling pain syndromes, 29 with pain disorder (PD) and 31 with pain as part of a multiple somatization syndrome (MSS) were compared before and after a structured cognitive-behavioral treatment. It was hypothesized that MSS patients show more psychological distress, are more severely disabled, and respond less to the treatment. Both groups were similar with respect to sociodemographic status, history of pain symptomatology and comorbidity with DSM-IV mental disorders. The results show that MSS patients had higher levels of affective and sensoric pain sensations as well as more pain-related disabilities. They were also less successful during treatment to reduce their pain-related depression and anxiety. Psychosocial functioning was improved only by PD patients, but remained almost unchanged in the MSS group. However, there were no group differences concerning general depression and hypochondriasis, dysfunctional attitudes towards body and health, and use of pain coping strategies. It is concluded that the DSM-IV distinction between 'pure' pain disorder and syndromes involving pain plus multiple somatoform symptoms cannot generally be confirmed, but further studies of validation are needed. Copyright 2000 European Federation of Chapters of the International Association for the Study of Pain.

  6. Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

    PubMed

    Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

    2017-07-14

    In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

  7. Estimating Treatment Effects from Contaminated Multi-Period Education Experiments: The Dynamic Impacts of Class Size Reductions. NBER Working Paper No. 15200

    ERIC Educational Resources Information Center

    Ding, Weili; Lehrer, Steven F.

    2009-01-01

    This paper introduces an empirical strategy to estimate dynamic treatment effects in randomized trials that provide treatment in multiple stages and in which various noncompliance problems arise such as attrition and selective transitions between treatment and control groups. Our approach is applied to the highly influential four year randomized…

  8. Effective radiation exposure evaluation during a one year follow-up of urolithiasis patients after extracorporeal shock wave lithotripsy.

    PubMed

    Kaynar, Mehmet; Tekinarslan, Erdem; Keskin, Suat; Buldu, İbrahim; Sönmez, Mehmet Giray; Karatag, Tuna; Istanbulluoglu, Mustafa Okan

    2015-01-01

    To determine and evaluate the effective radiation exposure during a one year follow-up of urolithiasis patients following the SWL (extracorporeal shock wave lithotripsy) treatment. Total Effective Radiation Exposure (ERE) doses for each of the 129 patients: 44 kidney stone patients, 41 ureter stone patients, and 44 multiple stone location patients were calculated by adding up the radiation doses of each ionizing radiation session including images (IVU, KUB, CT) throughout a one year follow-up period following the SWL. Total mean ERE values for the kidney stone group was calculated as 15, 91 mSv (5.10-27.60), for the ureter group as 13.32 mSv (5.10-24.70), and in the multiple stone location group as 27.02 mSv (9.41-54.85). There was no statistically significant differences between the kidney and ureter groups in terms of the ERE dose values (p = 0.221) (p >0.05). In the comparison of the kidney and ureter stone groups with the multiple stone location group; however, there was a statistically significant difference (p = 0.000) (p <0.05). ERE doses should be a factor to be considered right at the initiation of any diagnostic and/or therapeutic procedure. Especially in the case of multiple stone locations, due to the high exposure to ionized radiation, different imaging modalities with low dose and/or totally without a dose should be employed in the diagnosis, treatment, and follow-up bearing the aim to optimize diagnosis while minimizing the radiation dose as much as possible.

  9. Robot-assisted gait training in multiple sclerosis patients: a randomized trial.

    PubMed

    Schwartz, Isabella; Sajin, Anna; Moreh, Elior; Fisher, Iris; Neeb, Martin; Forest, Adina; Vaknin-Dembinsky, Adi; Karusis, Dimitrios; Meiner, Zeev

    2012-06-01

    Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5-7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

  10. Upper limb motor rehabilitation impacts white matter microstructure in multiple sclerosis.

    PubMed

    Bonzano, Laura; Tacchino, Andrea; Brichetto, Giampaolo; Roccatagliata, Luca; Dessypris, Adriano; Feraco, Paola; Lopes De Carvalho, Maria L; Battaglia, Mario A; Mancardi, Giovanni L; Bove, Marco

    2014-04-15

    Upper limb impairments can occur in patients with multiple sclerosis, affecting daily living activities; however there is at present no definite agreement on the best rehabilitation treatment strategy to pursue. Moreover, motor training has been shown to induce changes in white matter architecture in healthy subjects. This study aimed at evaluating the motor behavioral and white matter microstructural changes following a 2-month upper limb motor rehabilitation treatment based on task-oriented exercises in patients with multiple sclerosis. Thirty patients (18 females and 12 males; age=43.3 ± 8.7 years) in a stable phase of the disease presenting with mild or moderate upper limb sensorimotor deficits were randomized into two groups of 15 patients each. Both groups underwent twenty 1-hour treatment sessions, three times a week. The "treatment group" received an active motor rehabilitation treatment, based on voluntary exercises including task-oriented exercises, while the "control group" underwent passive mobilization of the shoulder, elbow, wrist and fingers. Before and after the rehabilitation protocols, motor performance was evaluated in all patients with standard tests. Additionally, finger motor performance accuracy was assessed by an engineered glove. In the same sessions, every patient underwent diffusion tensor imaging to obtain parametric maps of fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity. The mean value of each parameter was separately calculated within regions of interest including the fiber bundles connecting brain areas involved in voluntary movement control: the corpus callosum, the corticospinal tracts and the superior longitudinal fasciculi. The two rehabilitation protocols induced similar effects on unimanual motor performance, but the bimanual coordination task revealed that the residual coordination abilities were maintained in the treated patients while they significantly worsened in the control group (p=0.002). Further, in the treatment group white matter integrity in the corpus callosum and corticospinal tracts was preserved while a microstructural integrity worsening was found in the control group (fractional anisotropy of the corpus callosum and corticospinal tracts: p=0.033 and p=0.022; radial diffusivity of the corpus callosum and corticospinal tracts: p=0.004 and p=0.008). Conversely, a significant increase of radial diffusivity was observed in the superior longitudinal fasciculi in both groups (p=0.02), indicating lack of treatment effects on this structure, showing damage progression likely due to a demyelination process. All these findings indicate the importance of administering, when possible, a rehabilitation treatment consisting of voluntary movements. We also demonstrated that the beneficial effects of a rehabilitation treatment are task-dependent and selective in their target; this becomes crucial towards the implementation of tailored rehabilitative approaches. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  11. Efficacy of a foodlet-based multiple micronutrient supplement for preventing growth faltering, anemia, and micronutrient deficiency of infants: the four country IRIS trial pooled data analysis.

    PubMed

    Smuts, Cornelius M; Lombard, Carl J; Benadé, A J Spinnler; Dhansay, Muhammad A; Berger, Jacques; Hop, Le Thi; López de Romaña, Guillermo; Untoro, Juliawati; Karyadi, Elvina; Erhardt, Jürgen; Gross, Rainer

    2005-03-01

    Diets of infants across the world are commonly deficient in multiple micronutrients during the period of growth faltering and dietary transition from milk to solid foods. A randomized placebo controlled trial was carried out in Indonesia, Peru, South Africa, and Vietnam, using a common protocol to investigate whether improving status for multiple micronutrients prevented growth faltering and anemia during infancy. The results of the pooled data analysis of the 4 countries for growth, anemia, and micronutrient status are reported. A total of 1134 infants were randomized to 4 treatment groups, with 283 receiving a daily placebo (P), 283 receiving a weekly multiple micronutrient supplement (WMM), 280 received a daily multiple micronutrient (DMM) supplement, and 288 received daily iron (DI) supplements. The DMM group had a significantly greater weight gain, growing at an average rate of 207 g/mo compared with 192 g/mo for the WMM group, and 186 g/mo for the DI and P groups. There were no differences in height gain. DMM was also the most effective treatment for controlling anemia and iron deficiency, besides improving zinc, retinol, tocopherol, and riboflavin status. DI supplementation alone increased zinc deficiency. The prevalence of multiple micronutrient deficiencies at baseline was high, with anemia affecting the majority, and was not fully controlled even after 6 mo of supplementation. These positive results indicate the need for larger effectiveness trials to examine how to deliver supplements at the program scale and to estimate cost benefits. Consideration should also be given to increasing the dosages of micronutrients being delivered in the foodlets.

  12. Azathioprine versus Beta Interferons for Relapsing-Remitting Multiple Sclerosis: A Multicentre Randomized Non-Inferiority Trial

    PubMed Central

    Massacesi, Luca; Tramacere, Irene; Amoroso, Salvatore; Battaglia, Mario A.; Benedetti, Maria Donata; Filippini, Graziella; La Mantia, Loredana; Repice, Anna; Solari, Alessandra; Tedeschi, Gioacchino; Milanese, Clara

    2014-01-01

    For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥2 relapses in the last 2 years) were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR) over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150) were randomized in 2 groups (77 azathioprine, 73 β interferons). At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons). Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19–0.37) in the azathioprine and 0.39 (95% CI 0.30–0.51) in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01). MRI outcomes were analyzed in 97 patients (50 azathioprine and 47 β interferons). Annualized new T2 lesion rate was 0.76 (95% CI 0.61–0.95) in the azathioprine and 0.69 (95% CI 0.54–0.88) in the interferon group. Treatment discontinuations due to adverse events were higher (20.3% vs. 7.8%, p = 0.03) in the azathioprine than in the interferon group, and concentrated within the first months of treatment, whereas in the interferon group discontinuations occurred mainly during the second year. The results of this study indicate that efficacy of azathioprine is not inferior to that of β interferons for patients with relapsing-remitting multiple sclerosis. Considering also the convenience of the oral administration, and the low cost for health service providers, azathioprine may represent an alternative to interferon treatment, while the different side effect profiles of both medications have to be taken into account. Trial Registration EudraCT 2006-004937-13 PMID:25402490

  13. Effect of Bone Marrow-Derived Mononuclear Cell Treatment, Early or Late After Acute Myocardial Infarction: Twelve Months CMR and Long-Term Clinical Results.

    PubMed

    Sürder, Daniel; Manka, Robert; Moccetti, Tiziano; Lo Cicero, Viviana; Emmert, Maximilian Y; Klersy, Catherine; Soncin, Sabrina; Turchetto, Lucia; Radrizzani, Marina; Zuber, Michel; Windecker, Stephan; Moschovitis, Aris; Bühler, Ines; Kozerke, Sebastian; Erne, Paul; Lüscher, Thomas F; Corti, Roberto

    2016-07-22

    Intracoronary delivery of autologous bone marrow-derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction (AMI). To demonstrate long-term efficacy of BM-MNC treatment after AMI. In a multicenter study, we randomized 200 patients with large AMI in a 1:1:1 pattern into an open-labeled control and 2 BM-MNC treatment groups. In the BM-MNC groups, cells were either administered 5 to 7 days (early) or 3 to 4 weeks (late) after AMI. Cardiac magnetic resonance imaging was performed at baseline and after 12 months. The current analysis investigates the change from baseline to 12 months in global LV ejection fraction, LV volumes, scar size, and N-terminal pro-brain natriuretic peptide values comparing the 2 treatment groups with control in a linear regression model. Besides the complete case analysis, multiple imputation analysis was performed to address for missing data. Furthermore, the long-term clinical event rate was computed. The absolute change in LV ejection fraction from baseline to 12 months was -1.9±9.8% for control (mean±SD), -0.9±10.5% for the early treatment group, and -0.7±10.1% for the late treatment group. The difference between the groups was not significant, both for complete case analysis and multiple imputation analysis. A combined clinical end point occurred equally in all the groups. Overall, 1-year mortality was low (2.25%). Among patients with AMI and LV dysfunction, treatment with BM-MNC either 5 to 7 days or 3 to 4 weeks after AMI did not improve LV function at 12 months, compared with control. The results are limited by an important drop out rate. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00355186. © 2016 American Heart Association, Inc.

  14. Falls prevention and balance rehabilitation in multiple sclerosis: a bi-centre randomised controlled trial.

    PubMed

    Cattaneo, Davide; Rasova, Kamila; Gervasoni, Elisa; Dobrovodská, Gabriela; Montesano, Angelo; Jonsdottir, Johanna

    2018-03-01

    People with Multiple Sclerosis (PwMS) have a high incidence of accidental falls that have a potentially detrimental effect on their daily life participation. The effect of balance specific rehabilitation on clinical balance measures and frequency of falls in PwMS was studied. A bi-centre randomised rater-blinded controlled trial. Participants in both groups received 20 treatment sessions. Participants in the intervention group received treatment aimed at improving balance and mobility. Participants in the control group received treatments to reduce limitations at activity and body function level. Primary measures were frequency of fallers (>1 fall in two months) and responders (>3 points improvement) at the Berg Balance Scale (BBS). Data was analysed according to an intention to treat approach. One hundred and nineteen participants were randomised. Following treatment frequency of fallers was 22% in the intervention group and 23% in the control group, odds ratio (OR) and (confidence limits): 1.05 (0.41 to 2.77). Responders on the BBS were 28% in the intervention group and 33% in the control group, OR = 0.75 (0.30 to 1.91). At follow up ORs for fallers and responders at BBS were 0.98 (0.48 to 2.01) and 0.79 (0.26 to 2.42), respectively. Twenty sessions 2-3 times/week of balance specific rehabilitation did not reduce fall frequency nor improve balance suggesting the need for more frequent and challenging interventions. Implications for Rehabilitation Programs for balance rehabilitation can improve balance but their effects in fall prevention are unclear. Twenty treatments sessions 2/3 times per week did not reduced frequency of falls in MS. The comparison with similar studies suggests that higher intensity of practice of highly challenging balance activities appears to be critical to maximizing effectiveness.

  15. The immediate effect of neuromuscular joint facilitation (NJF) treatment on the standing balance in younger persons.

    PubMed

    Onoda, Ko; Huo, Ming; Maruyama, Hitoshi

    2015-05-01

    [Purpose] The aim of this study was to investigate the change in standing balance of younger persons after neuromuscular joint facilitation (NJF) treatment. [Subjects] The subjects were 57 healthy young people, who were divided into three groups: The NJF group, and the Proprioceptive Neuromuscular Facilitation (PNF) group and the control group. [Methods] Functional reach test and body sway were measured before and after intervention in three groups. Four hip patterns of NJF or PNF were used. Two-way ANOVA and multiple comparisons were performed. [Results] The rate of change of FRT in the NJF group increased than the PNF group. The root mean square area at NJF and PNF group increased than control group. [Conclusion] The results suggest that caput femoris rotation function can be improved by NJF treatment, and that improvement of caput femoris rotation contributes to improve dynamic balance.

  16. Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a.

    PubMed

    Rudick, R A; Pace, A; Rani, M R S; Hyde, R; Panzara, M; Appachi, S; Shrock, J; Maurer, S L; Calabresi, P A; Confavreux, C; Galetta, S L; Lublin, F D; Radue, E-W; Ransohoff, R M

    2009-06-09

    Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNbeta) in patients with relapsing-remitting multiple sclerosis (RRMS). We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNbeta-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNbeta. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri, Biogen Idec, Inc., Cambridge, MA) plus IM IFNbeta-1a (Avonex, Biogen Idec, Inc.) 30 microg compared with placebo plus IM IFNbeta-1a 30 microg. Clinical and MRI outcomes in patients treated with IM IFNbeta-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNbeta-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40). No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes. Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

  17. A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.

    PubMed

    Al-Smadi, J; Warke, K; Wilson, I; Cramp, A F L; Noble, G; Walsh, D M; Lowe-Strong, A S

    2003-11-01

    To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). A randomized double-blind placebo controlled clinical pilot study. Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz, 200 micros), TENS 2 (110 Hz, 200 micros), placebo TENS. Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. The following outcome measures were taken at weeks 1, 6, and 10: visual analogue scale (VAS) (for current LBP, right leg pain, left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP, right and left leg pain were also taken before and after treatment, and once a week during the follow-up period. Analysis showed no statistically significant effects for any of the data. However, both active treatment groups showed a trend of improvement in the majority of the outcome measures. Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality.

  18. Utilizing the Zero-One Linear Programming Constraints to Draw Multiple Sets of Matched Samples from a Non-Treatment Population as Control Groups for the Quasi-Experimental Design

    ERIC Educational Resources Information Center

    Li, Yuan H.; Yang, Yu N.; Tompkins, Leroy J.; Modarresi, Shahpar

    2005-01-01

    The statistical technique, "Zero-One Linear Programming," that has successfully been used to create multiple tests with similar characteristics (e.g., item difficulties, test information and test specifications) in the area of educational measurement, was deemed to be a suitable method for creating multiple sets of matched samples to be…

  19. Repression of Multiple Myeloma Growth and Preservation of Bone with Combined Radiotherapy and Anti-angiogenic Agent

    PubMed Central

    Jia, Dan; Koonce, Nathan A.; Halakatti, Roopa; Li, Xin; Yaccoby, Shmuel; Swain, Frances L.; Suva, Larry J.; Hennings, Leah; Berridge, Marc S.; Apana, Scott M.; Mayo, Kevin; Corry, Peter M.; Griffin, Robert J.

    2011-01-01

    The effects of ionizing radiation, with or without the antiangiogenic agent anginex (Ax), on multiple myeloma growth were tested in a SCID-rab mouse model. Mice carrying human multiple myeloma cell-containing pre-implanted bone grafts were treated weekly with various regimens for 8 weeks. Rapid multiple myeloma growth, assessed by bioluminescence intensity (IVIS), human lambda Ig light chain level in serum (ELISA), and the volume of bone grafts (caliper), was observed in untreated mice. Tumor burden in mice receiving combined therapy was reduced to 59% (by caliper), 43% (by ELISA), and 2% (by IVIS) of baseline values after 8 weeks of treatment. Ax or radiation alone slowed but did not stop tumor growth. Four weeks after the withdrawal of the treatments, tumor burden remained minimal in mice given Ax + radiation but increased noticeably in the other three groups. Multiple myeloma suppression by Ax + radiation was accompanied by a marked decrease in the number and activity of osteoclasts in bone grafts assessed by histology. Bone graft integrity was preserved by Ax + radiation but was lost in the other three groups, as assessed by microCT imaging and radiography. These results suggest that radiotherapy, when primed by anti-angiogenic agents, may be a potent therapy for focal multiple myeloma. PMID:20518660

  20. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma

    PubMed Central

    Dimopoulos, Meletios A.; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S.; Niesvizky, Ruben; Jakubowiak, Andrzej J.; San-Miguel, Jesus F.; Ludwig, Heinz; Buchanan, Jacqui; Cocks, Kim; Yang, Xinqun; Xing, Biao; Zojwalla, Naseem; Tonda, Margaret; Moreau, Philippe; Palumbo, Antonio

    2016-01-01

    Purpose To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. Methods Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment. The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups. Results Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points). There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively). Conclusion KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma. PMID:27601539

  1. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma.

    PubMed

    Stewart, A Keith; Dimopoulos, Meletios A; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S; Niesvizky, Ruben; Jakubowiak, Andrzej J; San-Miguel, Jesus F; Ludwig, Heinz; Buchanan, Jacqui; Cocks, Kim; Yang, Xinqun; Xing, Biao; Zojwalla, Naseem; Tonda, Margaret; Moreau, Philippe; Palumbo, Antonio

    2016-11-10

    Purpose To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. Methods Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment. The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups. Results Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points). There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively). Conclusion KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma.

  2. Examining the Efficacy of the Modified Story Memory Technique (mSMT) in Persons With TBI Using Functional Magnetic Resonance Imaging (fMRI): The TBI-MEM Trial.

    PubMed

    Chiaravalloti, Nancy D; Dobryakova, Ekaterina; Wylie, Glenn R; DeLuca, John

    2015-01-01

    New learning and memory deficits are common following traumatic brain injury (TBI). Yet few studies have examined the efficacy of memory retraining in TBI through the most methodologically vigorous randomized clinical trial. Our previous research has demonstrated that the modified Story Memory Technique (mSMT) significantly improves new learning and memory in multiple sclerosis. The present double-blind, placebo-controlled, randomized clinical trial examined changes in cerebral activation on functional magnetic resonance imaging following mSMT treatment in persons with TBI. Eighteen individuals with TBI were randomly assigned to treatment (n = 9) or placebo (n = 9) groups. Baseline and follow-up functional magnetic resonance imaging was collected during a list-learning task. Significant differences in cerebral activation from before to after treatment were noted in regions belonging to the default mode network and executive control network in the treatment group only. Results are interpreted in light of these networks. Activation differences between the groups likely reflect increased use of strategies taught during treatment. This study demonstrates a significant change in cerebral activation resulting from the mSMT in a TBI sample. Findings are consistent with previous work in multiple sclerosis. Behavioral interventions can show significant changes in the brain, validating clinical utility.

  3. Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis--a double blind, placebo controlled, randomised clinical trial.

    PubMed

    McClurg, D; Ashe, R G; Lowe-Strong, A S

    2008-01-01

    Lower urinary tract dysfunction affects up to 75% of the multiple sclerosis population. Results from our recent Pilot Study (McClurg et al., 2006) indicated that a combined programme of pelvic floor muscle training, electromyography biofeedback and neuromuscular electrical stimulation modalities may alleviate some of the distressing symptoms within this population. This clinical trial aimed to evaluate further the efficacy of these interventions and to establish the benefit of neuromuscular electrical stimulation above and beyond that of EMG biofeedback and pelvic floor muscle training. 74 multiple sclerosis patients who presented with lower urinary tract dysfunction were randomly allocated to one of two groups - Group 1 received Pelvic Floor Muscle Training, Electromyography Biofeedback and Placebo Neuromuscular Electrical Stimulation (n=37), and Group 2 which received Pelvic Floor Muscle Training, Electromyography Biofeedback, and Active Neuromuscular Electrical Stimulation (n=37). Treatment was for nine weeks with outcome measures recorded at weeks 0, 9, 16 and 24. The Primary Outcome Measure was the number of leakage episodes. Within group analysis was by Paired Samples t-test. Group differences were analysed using Repeated Measures Analysis of Variance and Post-hoc tests were used to determine the significance of differences between Groups at each time point. The mean number of incontinence episodes were reduced in Group 2 by 85% (p=0.001) whereas in Group 1 a lesser reduction of 47% (p=0.001) was observed. However, there was a statistically superior benefit in Group 2 when compared to Group 1 (p=0.0028). This superior benefit was evident in all other outcome measures. The addition of Active Neuromuscular Electrical Stimulation to a programme of Pelvic Floor Muscle Training and Electromyography Biofeedback should be considered as a first-line option in alleviating some of the symptoms of lower urinary tract dysfunction associated with multiple sclerosis. (c) 2007 Wiley-Liss, Inc.

  4. Multiple-dose safety study of ibuprofen/codeine and aspirin/codeine combinations.

    PubMed

    Friedman, H; Seckman, C; Stubbs, C; Oster, H; Royer, G

    1990-01-01

    This multiple-dose, double-blind, placebo-controlled, randomized, normal volunteer study compared formulations of ibuprofen/codeine and aspirin/codeine for systemic safety. Vital signs, hematologic, biochemical and urinary parameters, side effects, mood and mental alertness, were monitored. The placebo group had less gastrointestinal side effects and more frequent stools than the active treatment groups. There was statistical evidence for greater adverse effects of aspirin/codeine on mood and mental alertness in comparison to ibuprofen/codeine and placebo. Ibuprofen/codeine had a more favorable adverse effect profile than aspirin/codeine. A mild respiratory and cardiac depressant effect attributable to codeine was evident in all active treatment groups after 7 days of frequent therapy. More work needs to be done to elucidate the factors regulating the development of tolerance to the respiratory and cardiovascular depressant effects of opiates in general, and for codeine in particular.

  5. Nurse-led immunotreatment DEcision Coaching In people with Multiple Sclerosis (DECIMS) - Feasibility testing, pilot randomised controlled trial and mixed methods process evaluation.

    PubMed

    Rahn, A C; Köpke, S; Backhus, I; Kasper, J; Anger, K; Untiedt, B; Alegiani, A; Kleiter, I; Mühlhauser, I; Heesen, C

    2018-02-01

    Treatment decision-making is complex for people with multiple sclerosis. Profound information on available options is virtually not possible in regular neurologist encounters. The "nurse decision coach model" was developed to redistribute health professionals' tasks in supporting immunotreatment decision-making following the principles of informed shared decision-making. To test the feasibility of a decision coaching programme and recruitment strategies to inform the main trial. Feasibility testing and parallel pilot randomised controlled trial, accompanied by a mixed methods process evaluation. Two German multiple sclerosis university centres. People with suspected or relapsing-remitting multiple sclerosis facing immunotreatment decisions on first line drugs were recruited. Randomisation to the intervention (n = 38) or control group (n = 35) was performed on a daily basis. Quantitative and qualitative process data were collected from people with multiple sclerosis, nurses and physicians. We report on the development and piloting of the decision coaching programme. It comprises a training course for multiple sclerosis nurses and the coaching intervention. The intervention consists of up to three structured nurse-led decision coaching sessions, access to an evidence-based online information platform (DECIMS-Wiki) and a final physician consultation. After feasibility testing, a pilot randomised controlled trial was performed. People with multiple sclerosis were randomised to the intervention or control group. The latter had also access to the DECIMS-Wiki, but received otherwise care as usual. Nurses were not blinded to group assignment, while people with multiple sclerosis and physicians were. The primary outcome was 'informed choice' after six months including the sub-dimensions' risk knowledge (after 14 days), attitude concerning immunotreatment (after physician consultation), and treatment uptake (after six months). Quantitative process evaluation data were collected via questionnaires. Qualitative interviews were performed with all nurses and a convenience sample of nine people with multiple sclerosis. 116 people with multiple sclerosis fulfilled the inclusion criteria and 73 (63%) were included. Groups were comparable at baseline. Data of 51 people with multiple sclerosis (70%) were available for the primary endpoint. In the intervention group 15 of 31 (48%) people with multiple sclerosis achieved an informed choice after six months and 6 of 20 (30%) in the control group. Process evaluation data illustrated a positive response towards the coaching programme as well as good acceptance. The pilot-phase showed promising results concerning acceptability and feasibility of the intervention, which was well perceived by people with multiple sclerosis, most nurses and physicians. Delegating parts of the immunotreatment decision-making process to trained nurses has the potential to increase informed choice and participation as well as effectiveness of patient-physician consultations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. The role of radiation therapy in the treatment of solitary plasmacytomas.

    PubMed

    Mayr, N A; Wen, B C; Hussey, D H; Burns, C P; Staples, J J; Doornbos, J F; Vigliotti, A P

    1990-04-01

    Between 1960 and 1985, 30 patients with solitary plasmacytomas were treated with radiotherapy at the University of Iowa: 13 patients with extramedullary plasmacytomas (EMP) and 17 with solitary plasmacytomas of bone (SPB). The local control rates were 92% for patients with EMP and 88% for those with SPB. Two of nine patients (22%) with EMP treated to the primary tumor only developed regional lymph node metastasis, indicating the need for elective irradiation of this area. The most common pattern of failure in both groups was progression to multiple myeloma. This occurred in 23% of the patients with EMP and 53% of those with SPB. The time course of progression to multiple myeloma differed for the two groups. All of those who progressed to multiple myeloma in the EMP group did so within 2 years, whereas a significant number of those in the SPB group progressed more than 5 years after initial therapy. None of five patients who received adjuvant chemotherapy in the SPB group progressed to multiple myeloma, compared to 75% (9/12) of the patients who did not receive chemotherapy.

  7. Note Taking and Recall

    ERIC Educational Resources Information Center

    Fisher, Judith L.; Harris, Mary B.

    1974-01-01

    To study the effect of note taking and opportunity for review on subsequent recall, 88 college students were randomly assigned to five treatment groups utilizing different note taking and review combinations. No treatment effects were found, although quality of notes was positively correlated with free recall an multiple-choice measures.…

  8. Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

    PubMed

    Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

    2013-12-01

    The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

  9. A randomized controlled trial of cognitive behavioral therapy (CBT) for adjusting to multiple sclerosis (the saMS trial): does CBT work and for whom does it work?

    PubMed

    Moss-Morris, Rona; Dennison, Laura; Landau, Sabine; Yardley, Lucy; Silber, Eli; Chalder, Trudie

    2013-04-01

    The aims were (a) to test the effectiveness of a nurse-led cognitive behavioral therapy (CBT) program to assist adjustment in the early stages of multiple sclerosis (MS) and (b) to determine moderators of treatment including baseline distress, social support (SS), and treatment preference. Ninety-four ambulatory people with MS within 10 years of diagnosis were randomized to receive 8 individual sessions of CBT (n = 48) or supportive listening (n = 46), most delivered on the telephone, in a multicenter randomized controlled trial. The primary outcomes were distress and functional impairment. Secondary outcomes included global improvement, acceptance of illness, and dysfunctional cognitions. Assessments were completed at home and were coordinated by a blind assessor. Data were analyzed by intention-to-treat using multilevel models. The CBT group was significantly less distressed at the end of treatment (estimated General Health Questionnaire group difference = 3.2 points, 95\\% CI 1.1 to 5.4 points) and at the 12-month follow-up (estimated group difference = 2.2 points, 95\\% CI 0.01 to 4.4 points). There were no differences between the groups on functional impairment. The CBT group also demonstrated significantly greater improvements on secondary outcomes at the end of treatment but not at the 12-month follow-up. CBT participants with poor SS and/or clinically defined levels of distress at baseline showed significantly greater gains on both primary outcomes. Treatment preference did not moderate treatment effects. CBT is more effective than supportive listening in reducing distress in people with MS. CBT appears most effective for patients with poor SS and high levels of distress. The loss of gains in the secondary outcomes by 12 months suggests further follow-up sessions may be warranted.

  10. Effects of electro-acupuncture on personality traits in depression: a randomized controlled study.

    PubMed

    Wang, Wei-dong; Lu, Xue-yu; Ng, Siu-man; Hong, Lan; Zhao, Yang; Lin, Ying-na; Wang, Fang

    2013-10-01

    To explore the personality-adjusting effect of electro-acupuncture treatment for depression and compared this treatment with paroxetine treatment. A non-blinded, randomized controlled trial was adopted. Sixty depressed patients, who met trial criteria, were randomly assigned to the treatment and the control groups. In the treatment group, electro-acupuncture treatment was used, and paroxetine treatment was used in the control group. During the 24-week study period, 12 patients dropped out and 48 patients completed the study. The Minnesota Multiple Personality Inventory (MMPI) was adopted as the evaluation tool. At the same time, the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS) and Montgomery-Asberg Depression Rating Scale (MADRS) were used to evaluate the psychological state. Evaluations were done before and after treatment. After treatment, patients' psychological state improved significantly in both groups (P<0.01). For the treatment group, within-group comparison between baseline and after 24 weeks of treatment showed that severity of depression had significantly decreased (P<0.01). MADRS and SDS scores decreased significantly (P<0.05) and MMPI subscale scores for hypochondriasis, depression, psychopathic deviate, psychasthenia, social introversion and fake decreased significantly (P<0.05). For the control group, severity of depression also decreased significantly. MADRS and SDS scores decreased significantly (P<0.05); and MMPI subscale scores for hypochondriasis, depression, hysteria, paranoia, and psychasthenia decreased significantly (P<0.05). Between-group comparison demonstrated that for the MMPI subscales paranoia and social introversion, the decrease of score was greater in the treatment group than in the control group (P<0.05). However, there were no other significant differences between the control group and the treatment group. Electro-acupuncture is effective for treating depression and affects personality traits.

  11. Are the results of multiple drilling and alendronate for osteonecrosis of the femoral head better than those of multiple drilling? A pilot study.

    PubMed

    Kang, Pengde; Pei, Fuxing; Shen, Bin; Zhou, Zongke; Yang, Jing

    2012-01-01

    The treatment of osteonecrosis of the femoral head (ONFH) remains controversial. A recently proposed treatment is multiple drilling core decompression combined with systemic alendronate as a femoral head-preserving procedure for ONFH. However, it is not known whether alendronate enhances the risk of collapse. We wondered whether the combined procedure could delay or prevent progression of ONFH compared to multiple drilling alone. Patients with early-stage ONFH were randomly assigned to be treated with either multiple drilling combined with alendronate (47 patients, 67 hips) or multiple drilling alone (46 patients, 60 hips). We defined failure as the need for THA or a Harris score less than 70. The minimum follow-up was 48 months for the 77 patients completing the protocol. After a minimum 4-year follow-up, 91% (40/44) of patients with Stage II disease and 62% (8/13) of patients with Stage III disease had not required THA in alendronate group, compared to 79% (31/39) of patients with Stage II disease and 46% (6/13) of patients with Stage III disease had not required THA in control group (P=0.12, P=0.047, respectively). Small or medium and central lesions had a better successful rate in both groups. Risk factors did not seem to affect the clinical successful rate of this procedure. Multiple small-diameter drilling core decompression combined with systemic alendronate administration can reduce pain and delay progression of early-stage ONFH. Even in Ficat IIA and III hips, some benefit was obtained from this approach at least delay in the need for THA. Copyright © 2011. Published by Elsevier SAS.

  12. Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?

    PubMed

    Wason, James M S; Stecher, Lynne; Mander, Adrian P

    2014-09-17

    Multi-arm trials enable the evaluation of multiple treatments within a single trial. They provide a way of substantially increasing the efficiency of the clinical development process. However, since multi-arm trials test multiple hypotheses, some regulators require that a statistical correction be made to control the chance of making a type-1 error (false-positive). Several conflicting viewpoints are expressed in the literature regarding the circumstances in which a multiple-testing correction should be used. In this article we discuss these conflicting viewpoints and review the frequency with which correction methods are currently used in practice. We identified all multi-arm clinical trials published in 2012 by four major medical journals. Summary data on several aspects of the trial design were extracted, including whether the trial was exploratory or confirmatory, whether a multiple-testing correction was applied and, if one was used, what type it was. We found that almost half (49%) of published multi-arm trials report using a multiple-testing correction. The percentage that corrected was higher for trials in which the experimental arms included multiple doses or regimens of the same treatments (67%). The percentage that corrected was higher in exploratory than confirmatory trials, although this is explained by a greater proportion of exploratory trials testing multiple doses and regimens of the same treatment. A sizeable proportion of published multi-arm trials do not correct for multiple-testing. Clearer guidance about whether multiple-testing correction is needed for multi-arm trials that test separate treatments against a common control group is required.

  13. Effective radiation exposure evaluation during a one year follow-up of urolithiasis patients after extracorporeal shock wave lithotripsy

    PubMed Central

    Tekinarslan, Erdem; Keskin, Suat; Buldu, İbrahim; Sönmez, Mehmet Giray; Karatag, Tuna; Istanbulluoglu, Mustafa Okan

    2015-01-01

    Introduction To determine and evaluate the effective radiation exposure during a one year follow-up of urolithiasis patients following the SWL (extracorporeal shock wave lithotripsy) treatment. Material and methods Total Effective Radiation Exposure (ERE) doses for each of the 129 patients: 44 kidney stone patients, 41 ureter stone patients, and 44 multiple stone location patients were calculated by adding up the radiation doses of each ionizing radiation session including images (IVU, KUB, CT) throughout a one year follow-up period following the SWL. Results Total mean ERE values for the kidney stone group was calculated as 15, 91 mSv (5.10-27.60), for the ureter group as 13.32 mSv (5.10-24.70), and in the multiple stone location group as 27.02 mSv (9.41-54.85). There was no statistically significant differences between the kidney and ureter groups in terms of the ERE dose values (p = 0.221) (p >0.05). In the comparison of the kidney and ureter stone groups with the multiple stone location group; however, there was a statistically significant difference (p = 0.000) (p <0.05). Conclusions ERE doses should be a factor to be considered right at the initiation of any diagnostic and/or therapeutic procedure. Especially in the case of multiple stone locations, due to the high exposure to ionized radiation, different imaging modalities with low dose and/or totally without a dose should be employed in the diagnosis, treatment, and follow-up bearing the aim to optimize diagnosis while minimizing the radiation dose as much as possible. PMID:26568880

  14. Stabilization of multiple rib fractures in a canine model.

    PubMed

    Huang, Ke-Nan; Xu, Zhi-Fei; Sun, Ju-Xian; Ding, Xin-Yu; Wu, Bin; Li, Wei; Qin, Xiong; Tang, Hua

    2014-12-01

    Operative stabilization is frequently used in the clinical treatment of multiple rib fractures (MRF); however, no ideal material exists for use in this fixation. This study investigates a newly developed biodegradable plate system for the stabilization of MRF. Silk fiber-reinforced polycaprolactone (SF/PCL) plates were developed for rib fracture stabilization and studied using a canine flail chest model. Adult mongrel dogs were divided into three groups: one group received the SF/PCL plates, one group received standard clinical steel plates, and the final group did not undergo operative fracture stabilization (n = 6 for each group). Radiographic, mechanical, and histologic examination was performed to evaluate the effectiveness of the biodegradable material for the stabilization of the rib fractures. No nonunion and no infections were found when using SF-PCL plates. The fracture sites collapsed in the untreated control group, leading to obvious chest wall deformity not encountered in the two groups that underwent operative stabilization. Our experimental study shows that the SF/PCL plate has the biocompatibility and mechanical strength suitable for fixation of MRF and is potentially ideal for the treatment of these injuries. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial

    PubMed Central

    Edan, Gilles; Freedman, Mark S.; Montalbán, Xavier; Hartung, Hans-Peter; Hemmer, Bernhard; Fox, Edward J.; Barkhof, Frederik; Schippling, Sven; Schulze, Andrea; Pleimes, Dirk; Pohl, Christoph; Sandbrink, Rupert; Suarez, Gustavo; Wicklein, Eva-Maria

    2016-01-01

    Objective: To assess outcomes for patients treated with interferon beta-1b immediately after clinically isolated syndrome (CIS) or after a short delay. Methods: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on placebo could switch to interferon beta-1b or another treatment. Eleven years after randomization, patients were reassessed. Results: Two hundred seventy-eight (59.4%) of the original 468 patients (71.3% of those eligible at participating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk of CDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p = 0.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931 [253, 3,296]; p = 0.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p = 0.0018). Only 25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiple sclerosis. Expanded Disability Status Scale scores remained low and stable, with no difference between treatment arms (median [Q1, Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better Paced Auditory Serial Addition Task–3 total scores (p = 0.0070). Employment rates remained high, and health resource utilization tended to be low in both groups. MRI metrics did not differ between groups. Conclusions: Although the delay in treatment was relatively short, several clinical outcomes favored earlier treatment. Along with low rates of disability and disease progression in both groups, this supports the value of treatment at CIS. ClinicalTrials.gov identifier: NCT01795872. Classification of evidence: This study provides Class IV evidence that early compared to delayed treatment prolongs time to CDMS in CIS after 11 years. PMID:27511182

  16. Intervening with High Risk Youth: A Program Model.

    ERIC Educational Resources Information Center

    Davis, Ruth B.; And Others

    1994-01-01

    Describes a program for older adolescents exhibiting substance use problems. After initial assessment and referral, most patients enter outpatient treatment groups. Groups fulfill three purposes: (1) Staff monitors clients; (2) Help clients recognize the promise of recovery; and (3) Change behavior. Difficulties of working with multiple community…

  17. [Clinical effect of compound monoammonium glycyrrhizinate combined with dandelion in treatment of acute paraquat poisoning].

    PubMed

    Zhao, Y; Jian, X D

    2016-07-20

    Objective: To investigate the clinical effect of compound monoammonium glycyrrhizinate combined with dandelion in the treatment of acute paraquat poisoning. Methods: A total of 80 patients with acute paraquat poisoning who were admitted to our hospital were enrolled as study subjects and randomly divided into routine treatment group (38 patients) and traditional Chinese medicine (TCM) group (42 patients) . The patients in the TCM group were given compound monoammonium glycyrrhizinate and dandelion in addition to the treatment in the control group. Serum alanine aminotransferase (ALT) , total bilirubin (TBil) , blood urea nitrogen (BUN) , creatinine (Cr) , and arterial blood lactate (Lac) and partial pressure of oxygen (PaO 2 ) during different time periods on day 3, 7, and 9 of treatment were observed in both groups, and ulceration of oral mucosa, pulmonary fibrosis, multiple organ dysfunction syndrome (MODS) , and mortality were compared between the two groups. Results: On days 3, 7, and 9 of treatment, the routine treatment group had significantly higher serum ALT, TBil, BUN, Cr, and arterial blood Lac than the TCM group. The routine treatment group had significantly lower arterial blood PaO 2 than the TCM group, while the TCM group had significantly lower incidence rates of ulceration of oral mucosa, pulmonary fibrosis, and MODS and a significantly lower mortality rate than the routine treatment group ( P <0.05) . Conclusion: In the treatment of patients with acute paraquat poisoning, compound monoammonium glycyrrhizinate combined with dandelion can effectively improve organ function, reduce the incidence of pulmonary fibrosis and MODS, improve the healing rate of oral ulcer, improve prognosis, and reduce mortality rate.

  18. Day patient treatment for traumatic grief: preliminary evaluation of a one-year treatment programme for patients with multiple and traumatic losses

    PubMed Central

    de Heus, Annemiek; Hengst, Sophie M. C.; de la Rie, Simone M.; Djelantik, A. A. A. Manik J.; Boelen, Paul A.; Smid, Geert E.

    2017-01-01

    ABSTRACT Background: Bereaved individuals who have lost a loved one under traumatic circumstances can develop symptoms of Persistent Complex Bereavement Disorder (PCBD) and/or Posttraumatic Stress Disorder (PTSD). This is particularly common in refugees, as they frequently have been confronted with multiple traumatic losses. For patients with severe PTSD and traumatic grief a treatment programme was developed, embedding individual traumatic grief focused therapy in a group-based multidisciplinary day patient treatment programme. The day patient treatment comprised a weekly five-hour programme consisting of three phases with a duration of four months each. Objective: To evaluate the feasibility and potential effectiveness of the treatment programme. Method: Data were analyzed from 16 participants treated between October 2013 and March 2014. PTSD severity and PTSD/PCBD diagnoses were measured during the initial and final phases of treatment using the Clinician-Administered PTSD Scale for DSM-IV (CAPS) and the Traumatic Grief Inventory Self Report (TGI-SR). One clinical case is presented in more detail. Treatment attendance was also registered and therapist satisfaction was evaluated in a focus group. Results: Thirteen patients (81%) completed the treatment. Each day of the treatment programme was attended by a mean of 76% of the participants. In the focus group, therapists noted symptom reduction in their patients and they therefore regarded Brief Eclectic Psychotherapy for Traumatic Grief (BEP-TG) as an effective therapy for their patients. During treatment, significant decreases in PTSD severity as well as diagnosable PTSD and PCBD were observed. Conclusions: Results support the feasibility and potential effectiveness of the day patient treatment programme for traumatic grief. The programme appears to be particularly suitable for refugees with severe PTSD and PCBD psychopathology, who may not benefit enough from usual care. PMID:29038679

  19. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial.

    PubMed

    Gandolfi, Marialuisa; Munari, Daniele; Geroin, Christian; Gajofatto, Alberto; Benedetti, Maria Donata; Midiri, Alessandro; Carla, Fontana; Picelli, Alessandro; Waldner, Andreas; Smania, Nicola

    2015-10-01

    Impaired sensory integration contributes to balance disorders in patients with multiple sclerosis (MS). The objective of this paper is to compare the effects of sensory integration balance training against conventional rehabilitation on balance disorders, the level of balance confidence perceived, quality of life, fatigue, frequency of falls, and sensory integration processing on a large sample of patients with MS. This single-blind, randomized, controlled trial involved 80 outpatients with MS (EDSS: 1.5-6.0) and subjective symptoms of balance disorders. The experimental group (n = 39) received specific training to improve central integration of afferent sensory inputs; the control group (n = 41) received conventional rehabilitation (15 treatment sessions of 50 minutes each). Before, after treatment, and at one month post-treatment, patients were evaluated by a blinded rater using the Berg Balance Scale (BBS), Activities-specific Balance Confidence Scale (ABC), Multiple Sclerosis Quality of Life-54, Fatigue Severity Scale (FSS), number of falls and the Sensory Organization Balance Test (SOT). The experimental training program produced greater improvements than the control group training on the BBS (p < 0.001), the FSS (p < 0.002), number of falls (p = 0.002) and SOT (p < 0.05). Specific training to improve central integration of afferent sensory inputs may ameliorate balance disorders in patients with MS. Clinical Trial Registration (NCT01040117). © The Author(s), 2015.

  20. [Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

    PubMed

    Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

    2016-02-14

    Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

  1. Oral health-related quality of life in pediatric patients under general anesthesia: A prospective study.

    PubMed

    Li, Lanlan; Wang, Hongwei; Han, Xueping

    2017-01-01

    Our goal was to evaluate how dental treatments under general anesthesia (GA) affect the quality of life by a prospective pair-matched design. Pediatric patients, who had received dental treatments under GA, were enrolled and were asked to complete the Early Childhood Oral Health Impact Scale (ECOHIS) before the treatment and 1 month after the treatment. To shield the observed impacts, a pair-matched control group was performed. Patients in the control group were also required to complete the ECOHIS at these different points in time. In both groups, the items of troubled sleep and oral/dental pain scored highest, whereas avoiding smiling or laughing and avoiding talking scored lowest before the treatment. The total mean score in the 2 groups was 13.1 and 13.7, respectively, and there was no significant statistical difference (P > 0.05). However, the total mean score was 1.9 in the experimental group after the treatment and smaller compared with the control group (1.9 vs. 4.7, P < 0.001). The majority of the items in both groups had an apparent effect size and the total mean effect in the experimental group was greater than that in the control group (85.5% vs. 65.7%, P < 0.001). Therefore, dental treatment under GA could provide better quality of life restoration compared with treatment over multiple visits.

  2. Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

    ERIC Educational Resources Information Center

    Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

    2013-01-01

    Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

  3. Multiple Representation Instruction First versus Traditional Algorithmic Instruction First: Impact in Middle School Mathematics Classrooms

    ERIC Educational Resources Information Center

    Flores, Raymond; Koontz, Esther; Inan, Fethi A.; Alagic, Mara

    2015-01-01

    This study examined the impact of the order of two teaching approaches on students' abilities and on-task behaviors while learning how to solve percentage problems. Two treatment groups were compared. MR first received multiple representation instruction followed by traditional algorithmic instruction and TA first received these teaching…

  4. Multiple Use. Instructor Guide. Working for Clean Water: An Information Program for Advisory Groups.

    ERIC Educational Resources Information Center

    Buskirk, E. Drannon, Jr.

    Examined is the use of wastewater treatment facilities for recreation, education, and open space. Objectives of the learning session described in this instructor's manual are to: (1) introduce opportunities for multiple use, (2) identify areas for citizen input in facility planning and design, and (3) provide criteria for determining local needs…

  5. Three treatments for bilingual children with primary language impairment: Examining cross-linguistic and cross-domain effects

    PubMed Central

    Ebert, Kerry Danahy; Kohnert, Kathryn; Pham, Giang; Disher, Jill Rentmeester; Payesteh, Bita

    2014-01-01

    Purpose This study examines the absolute and relative effects of three different treatment programs for school-aged bilingual children with primary or specific language impairment (PLI). It serves to expand the evidence base on which service providers can base treatment decisions. It also explores hypothesized relations between languages and cognition in bilinguals with PLI. Method Fifty-nine school-aged Spanish-English bilingual children with PLI were assigned to receive nonlinguistic cognitive processing, English, bilingual (Spanish-English), or deferred treatment. Participants in each of the three active treatments received treatment administered by nationally certified speech-language pathologists. Pre- and post-treatment assessments measured change in nonlinguistic cognitive processing, English, and Spanish skills, and analyses examined change within and across both treatment groups and skill domains. Results All active treatment groups made significant pre- to post-treatment improvement on multiple outcome measures. There were fewer significant changes in Spanish than in English across groups. Between group comparisons indicate that the active treatment groups generally outperformed the deferred treatment control, reaching statistical significance for two tasks. Conclusions Results provide insight into cross-language transfer in bilingual children and advance understanding of the general PLI profile with respect to relationships between basic cognitive processing and higher level language skills. PMID:23900032

  6. A randomised controlled trial of combined EEG feedback and methylphenidate therapy for the treatment of ADHD.

    PubMed

    Li, Li; Yang, Li; Zhuo, Chuan-jun; Wang, Yu-Feng

    2013-08-22

    To evaluate the efficacy of combined methylphenidate and EEG feedback treatment for children with ADHD. Forty patients with ADHD were randomly assigned to the combination group (methylphenidate therapy and EEG feedback training) or control group (methylphenidate therapy and non-feedback attention training) in a 1:1 ratio using the double-blind method. These patients, who met the DSM-IV diagnostic criteria and were aged between 7 and 16 years, had obtained optimal therapeutic effects by titrating the methylphenidate dose prior to the trial. The patients were assessed using multiple parameters at baseline, after 20 treatment sessions, after 40 treatment sessions, and in 6-month follow-up studies. Compared to the control group, patients in the combination group had reduced ADHD symptoms and improved in related behavioural and brain functions. The combination of EEG feedback and methylphenidate treatment is more effective than methylphenidate alone. The combined therapy is especially suitable for children and adolescents with ADHD who insufficiently respond to single drug treatment or experience drug side effects.

  7. Comparison of transcutaneous contrast-enhanced ultrasound-guided injected hemostatic agents with traditional surgery treatment for liver, spleen and kidney trauma: a retrospective study.

    PubMed

    Wang, Dong; Lv, Faqin; Luo, Yukun; An, Lichun; Li, Junlai; Xie, Xia; Tian, Jiangke; Zhao, Weiyan; Tang, Jie

    2012-10-01

    There is lack of studies on the effectiveness of transcutaneous contrast-enhanced ultrasound-guided injections of hemostatic agents for liver. spleen and kidney trauma. We compared treatment by hemostatic agents to surgical treatment in a retrospective interventional human study. The study enrolled a total of 135 subjects from emergency unit of the Chinese People's Liberation Army General Hospital in Beijing. Within the cohort, 62 patients received contrast enhanced ultrasound-guided injection of hemostatic agents and the rest received surgical treatments. The injury severity score was lower in the hemostatic agent treatment group than surgical treatment group (p<0.05), but Glasgow coma scale scores did not reach statistical significance. The patients in the surgical treatment group had significantly higher hospital fees than those in the hemostatic treatment group (p<0.05), although the length of hospitalization did not significantly differ between two groups. Safety outcome variables pre- and post-treatment remained within normal limits in both groups. Hemostatic agents were more cost-effective than surgery to treat patients with liver, spleen and kidney trauma. However, given the limited sample size, subsequent studies drawing upon larger populations from multiple medical centers are necessary for follow-up.

  8. Treatment Failure after Multiple Courses of Triclabendazole among Patients with Fascioliasis in Cusco, Peru: A Case Series

    PubMed Central

    Cabada, Miguel M.; Lopez, Martha; Cruz, Maria; Delgado, Jennifer R.; Hill, Virginia; White, A. Clinton

    2016-01-01

    Triclabendazole is reported to be highly effective in treatment of human fascioliasis. We present 7 of 19 selected cases of human fascioliasis referred to our center in the Cusco region of Peru that failed to respond to triclabendazole. These were mostly symptomatic adults of both sexes that continued passing Fasciola eggs in the stool despite multiple treatments with 2 doses of triclabendazole at 10 mg/kg per dose. We documented the presence of eggs by rapid sedimentation and Kato Katz tests after each treatment course. We found that repeated triclabendazole courses were not effective against fascioliasis in this group of people. These findings suggest that resistance to triclabendazole may be an emerging problem in the Andes. PMID:26808543

  9. Treatment Failure after Multiple Courses of Triclabendazole among Patients with Fascioliasis in Cusco, Peru: A Case Series.

    PubMed

    Cabada, Miguel M; Lopez, Martha; Cruz, Maria; Delgado, Jennifer R; Hill, Virginia; White, A Clinton

    2016-01-01

    Triclabendazole is reported to be highly effective in treatment of human fascioliasis. We present 7 of 19 selected cases of human fascioliasis referred to our center in the Cusco region of Peru that failed to respond to triclabendazole. These were mostly symptomatic adults of both sexes that continued passing Fasciola eggs in the stool despite multiple treatments with 2 doses of triclabendazole at 10 mg/kg per dose. We documented the presence of eggs by rapid sedimentation and Kato Katz tests after each treatment course. We found that repeated triclabendazole courses were not effective against fascioliasis in this group of people. These findings suggest that resistance to triclabendazole may be an emerging problem in the Andes.

  10. Different clinical response to interferon beta and glatiramer acetate related to the presence of oligoclonal IgM bands in CSF in multiple sclerosis patients.

    PubMed

    Casanova, Bonaventura; Lacruz, Laura; Villar, María Luisa; Domínguez, José Andrés; Gadea, María Carcelén; Gascón, Francisco; Mallada, Javier; Hervás, David; Simó-Castelló, María; Álvarez-Cermeño, José Carlos; Calles, Carmen; Olascoaga, Javier; Ramió-Torrentà, Lluís; Alcalá, Carmen; Cervelló, Angeles; Boscá, Isabel; Pérez-Mirallles, Francisco Carlos; Coret, Francisco

    2018-06-07

    To study the efficacy of interferon beta (IFNβ) and glatiramer acetate (GA) related to the presence of oligoclonal M bands (OCMB) in the cerebrospinal fluid in relapsing-remitting multiple sclerosis (RRMS). This is an observational, multicenter and retrospective study with prospectively collected data of patients that started treatment with IFNβ or GA. Treatment decision was made blinded to the OCMB status. Time to first attack after starting therapy was compared by using Kaplan-Meier curves, and adjustment by Cox regression analysis was performed. Two hundred and fifty-six patients entered in the study (141-55% received IFNβ; 115-45% received GA). After a mean follow-up of 41 and 65 months, 54.7% of patients remained free from further attacks (RF). The proportion of RF patients was higher in the GA group than in the IFNβ group (72.2 vs. 40.4%, p < 0.001). The IFNβ patients with OCMB+ presented the poorest response, 31.3% RF vs. 48.1% in IFNβ without OCMB, p = 0.03. OCMB in CSF could be a biomarker of treatment response in multiple sclerosis.

  11. Dynamic sequence analysis of a decision making task of multielement target tracking and its usage as a learning method

    NASA Astrophysics Data System (ADS)

    Kang, Ziho

    This dissertation is divided into four parts: 1) Development of effective methods for comparing visual scanning paths (or scanpaths) for a dynamic task of multiple moving targets, 2) application of the methods to compare the scanpaths of experts and novices for a conflict detection task of multiple aircraft on radar screen, 3) a post-hoc analysis of other eye movement characteristics of experts and novices, and 4) finding out whether the scanpaths of experts can be used to teach the novices. In order to compare experts' and novices' scanpaths, two methods are developed. The first proposed method is the matrix comparisons using the Mantel test. The second proposed method is the maximum transition-based agglomerative hierarchical clustering (MTAHC) where comparisons of multi-level visual groupings are held out. The matrix comparison method was useful for a small number of targets during the preliminary experiment, but turned out to be inapplicable to a realistic case when tens of aircraft were presented on screen; however, MTAHC was effective with large number of aircraft on screen. The experiments with experts and novices on the aircraft conflict detection task showed that their scanpaths are different. The MTAHC result was able to explicitly show how experts visually grouped multiple aircraft based on similar altitudes while novices tended to group them based on convergence. Also, the MTAHC results showed that novices paid much attention to the converging aircraft groups even if they are safely separated by altitude; therefore, less attention was given to the actual conflicting pairs resulting in low correct conflict detection rates. Since the analysis showed the scanpath differences, experts' scanpaths were shown to novices in order to find out its effectiveness. The scanpath treatment group showed indications that they changed their visual movements from trajectory-based to altitude-based movements. Between the treatment and the non-treatment group, there were no significant differences in terms of number of correct detections; however, the treatment group made significantly fewer false alarms.

  12. Single-visit or multiple-visit root canal treatment: systematic review, meta-analysis and trial sequential analysis.

    PubMed

    Schwendicke, Falk; Göstemeyer, Gerd

    2017-02-01

    Single-visit root canal treatment has some advantages over conventional multivisit treatment, but might increase the risk of complications. We systematically evaluated the risk of complications after single-visit or multiple-visit root canal treatment using meta-analysis and trial-sequential analysis. Controlled trials comparing single-visit versus multiple-visit root canal treatment of permanent teeth were included. Trials needed to assess the risk of long-term complications (pain, infection, new/persisting/increasing periapical lesions ≥1 year after treatment), short-term pain or flare-up (acute exacerbation of initiation or continuation of root canal treatment). Electronic databases (PubMed, EMBASE, Cochrane Central) were screened, random-effects meta-analyses performed and trial-sequential analysis used to control for risk of random errors. Evidence was graded according to GRADE. 29 trials (4341 patients) were included, all but 6 showing high risk of bias. Based on 10 trials (1257 teeth), risk of complications was not significantly different in single-visit versus multiple-visit treatment (risk ratio (RR) 1.00 (95% CI 0.75 to 1.35); weak evidence). Based on 20 studies (3008 teeth), risk of pain did not significantly differ between treatments (RR 0.99 (95% CI 0.76 to 1.30); moderate evidence). Risk of flare-up was recorded by 8 studies (1110 teeth) and was significantly higher after single-visit versus multiple-visit treatment (RR 2.13 (95% CI 1.16 to 3.89); very weak evidence). Trial-sequential analysis revealed that firm evidence for benefit, harm or futility was not reached for any of the outcomes. There is insufficient evidence to rule out whether important differences between both strategies exist. Dentists can provide root canal treatment in 1 or multiple visits. Given the possibly increased risk of flare-ups, multiple-visit treatment might be preferred for certain teeth (eg, those with periapical lesions). 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/.

  13. School-based mental health programming for children with inattentive and disruptive behavior problems: first-year treatment outcome.

    PubMed

    Owens, Julie Sarno; Richerson, Lauren; Beilstein, Elizabeth A; Crane, Anna; Murphy, Caroline E; Vancouver, Jeffrey B

    2005-08-01

    This article examines the effectiveness of an evidence-based behavioral treatment package for children with inattentive and disruptive behavior problems when delivered in the context of a school-based mental health program. Child symptomatology and functioning are assessed in a treatment group (n = 30) and a waitlist control group (n = 12) across multiple time points (fall, winter, and spring). Treatment includes a daily report card procedure, year-long teacher consultation, and parenting sessions. According to the parent report, treated children show marked reductions in hyperactive and impulsive, oppositional or defiant and aggressive behavior, and marked improvement in peer relationships. Teachers observe treatment-related group differences in inattention, academic functioning, and the student-teacher relationship. Feasibility and acceptability data have implications for transporting evidence-based treatments to community settings and for integrating mental health services into the culture of the school community.

  14. Effectiveness of rehabilitation in multiple sclerosis relapse on fatigue, self-efficacy and physical activity.

    PubMed

    Nedeljkovic, Una; Raspopovic, Emilija Dubljanin; Ilic, Nela; Vujadinovic, Sanja Tomanovic; Soldatovic, Ivan; Drulovic, Jelena

    2016-09-01

    Relapse of disease is one of the most prominent characteristics of multiple sclerosis. Effectiveness of rehabilitation programmes on fatigue, self-efficacy (SE) and physical activity (PA) has not been investigated so far in context of relapse. The aim of our study was to examine if rehabilitation programme in addition to high-dose methylprednisolone (HDMP) during relapse of disease can influence fatigue, SE and PA more than corticosteroid therapy alone. Patients were randomized in control group receiving only HDMP and experimental group which was in addition included in rehabilitation programme. Outcome measures used were Fatigue Severity Scale (FSS), Multiple Sclerosis Self- Efficacy scale (MSSES), Godin Leisure-Time Exercise Questionnaire (GLTEQ), completed on baseline, 1 and 3 months later. There was no significant change in FSS in both time points, despite different trend seen between groups. The mean MSSES for function and control improved significantly in treatment group after 1 month (807.1 ± 96.8, p = 0.005; 665.3 ± 145.1, p = 0.05) and 3 months (820 ± 83.5, p = 0.004; 720.0 ± 198.2, p = 0.016.) compared to baseline values. The mean GLTEQ score was significantly higher in the treatment group compared to the control at both follow-up time points (45.7 ± 7.6, p < 0.001; 34.3 ± 22.4, p < 0.01). Rehabilitation started along with corticosteroid treatment induced significant improvement in PA compared to HDMP therapy alone. It also influenced noticeable changes in self-efficacy, but effect on fatigue was insufficient.

  15. Multiple Free Internal Limiting Membrane Flap Insertion in the Treatment of Macular Hole-Associated Retinal Detachment in High Myopia.

    PubMed

    Chen, San-Ni; Hsieh, Yi-Ting; Yang, Chung-May

    2018-06-06

    The aim of this paper was to evaluate the efficacy of multiple free internal limiting membrane (ILM) flap insertion in the management of macular hole-associated retinal detachment in high myopia. Eyes receiving operation for macular hole-associated retinal detachment were retrospectively recruited. Those in the study group received ILM peeling and multiple free ILM flap insertion, while those in the control group received ILM peeling only. Postoperative anatomical outcomes and best-corrected visual acuity were compared between the 2 groups. Twenty-seven eyes of 27 patients were recruited in this study (13 in the study group, 14 in the control group). After the operation, the retina was reattached in all cases in both groups. The macular hole closure rate was 100% in the study group but only 42.9% in the control group (adjusted p < 0.001). The eyes in the study group had better visual improvement (logMAR -0.58 ± 0.43) than those in the control group (logMAR -0.31 ± 0.50) with borderline significance (adjusted p = 0.078). For macular hole-associated retinal detachment in highly myopic eyes, the multiple free ILM flap insertion technique offers an effective way to close macular holes. Whether this result also means better visual outcome remains to be seen. © 2018 S. Karger AG, Basel.

  16. Does Renal Artery Supply Indicate Treatment Success of Renal Denervation?

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Schmid, Axel, E-mail: axel.schmid@uk-erlangen.de; Ditting, Tilmann, E-mail: tilmann.ditting@uk-erlangen.de; Sobotka, Paul A., E-mail: sobotka@alumni.stanford.edu

    PurposeRenal denervation (RDN) emerged as an innovative interventional antihypertensive therapy. With the exception of pretreatment blood pressure (BP) level, no other clear predictor for treatment efficacy is yet known. We analyzed whether the presence of multiple renal arteries has an impact on BP reduction after RDN.MethodsFifty-three patients with treatment-resistant hypertension (office BP {>=} 140/90 mmHg and 24-h ambulatory BP monitoring ({>=}130/80 mmHg) underwent bilateral catheter-based RDN. Patients were stratified into one-vessel (OV) (both sides) and at least multivessel (MV) supply at one side. Both groups were treated on one vessel at each side; in case of multiple arteries, only themore » dominant artery was treated on each side.ResultsBaseline clinical characteristics (including BP, age, and estimated glomerular filtration rate) did not differ between patients with OV (n = 32) and MV (n = 21). Office BP was significantly reduced in both groups at 3 months (systolic: OV -15 {+-} 23 vs. MV -16 {+-} 20 mmHg; diastolic: OV -10 {+-} 12 vs. MV -8 {+-} 11 mmHg, both p = NS) as well as 6 months (systolic: OV -18 {+-} 18 vs. MV -17 {+-} 22 mmHg; diastolic: OV -10 {+-} 10 vs. -10 {+-} 12 mmHg, both p = NS) after RDN. There was no difference in responder rate (rate of patients with office systolic BP reduction of at least 10 mmHg after 6 months) between the groups.ConclusionIn patients with multiple renal arteries, RDN of one renal artery-namely, the dominant one-is sufficient to induce BP reduction in treatment-resistant hypertension.« less

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

    PubMed

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

    2016-04-01

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

  18. Roles of frequency, attitudes, and multiple intelligence modality surrounding Electricity Content-Based Reader's Theatre

    NASA Astrophysics Data System (ADS)

    Hosier, Julie Winchester

    Integration of subjects is something elementary teachers must do to insure required objectives are covered. Science-based Reader's Theatre is one way to weave reading into science. This study examined the roles of frequency, attitudes, and Multiple Intelligence modalities surrounding Electricity Content-Based Reader's Theatre. This study used quasi-experimental, repeated measures ANOVA with time as a factor design. A convenience sample of two fifth-grade classrooms participated in the study for eighteen weeks. Five Electricity Achievement Tests were given throughout the study to assess students' growth. A Student Reader's Theatre Attitudinal Survey revealed students' attitudes before and after Electricity Content-Based Reader's Theatre treatment. The Multiple Intelligence Inventory for Kids (Faris, 2007) examined whether Multiple Intelligence modality played a role in achievement on Electricity Test 4, the post-treatment test. Analysis using repeated measures ANOVA and an independent t-test found that students in the experimental group, which practiced its student-created Electricity Content-Based Reader's Theatre skits ten times versus two times for the for control group, did significantly better on Electricity Achievement Test 4, t(76) = 3.018, p = 0.003. Dependent t-tests did not find statistically significant differences between students' attitudes about Electricity Content-Based Reader's Theatre before and after treatment. A Kruskal-Wallis test found no statistically significant difference between the various Multiple Intelligence modalities score mean ranks (x2 = 5.57, df = 2, alpha = .062). Qualitative data do, however, indicate students had strong positive feelings about Electricity Content-Based Reader's Theatre after treatment. Students indicated it to be motivating, confidence-building, and a fun way to learn about science; however, they disliked writing their own scripts. Examining the frequency, attitudes, and Multiple Intelligence modalities lead to the conclusion that the role of frequency had the greatest impact on the success of Electricity Content-Based Reader's Theatre. The participating teachers, students, and research found integrating science and reading through Electricity Content-Based Reader's Theatre beneficial.

  19. Single dose parenteral hyposensitization to poison ivy urushiol in guinea pigs.

    PubMed

    Walker, L A; Watson, E S; elSohly, M A

    1995-08-01

    Studies were carried out in guinea pigs to evaluate the potential for single dose hyposensitization to poison ivy urushiol dermatitis. Sensitization was induced by topical application of 1 mg of poison ivy urushiol to the back of the neck. In the first series of studies, three different analogs of poison ivy urushiol were studied: 1) a mixture of pentadecyl and heptadecyl catechols (PDC/HDC), the saturated side chain analog of the natural urushiol mixture; 2) a mixture of the diacetate esters of PDC and HDC (PDC/HDC Ac), the esterified form of the saturated sidechain analogs; 3) 2-n-pentadecyl hydroquinone diacetate (HQ Ac). Each of these compounds was administered as 5 mg of the free catechol i.m. each week for three weeks. A vehicle group received only corn oil injections. Reactivity to poison ivy urushiol (PIU) challenge was evaluated in skin tests at 1 and 5 weeks post-treatment. PDC/HDC Ac induced a marked reduction in both the incidence and the severity of lesions induced by PIU at both 1 and at 5 weeks post-treatment. Other analogs were ineffective at 5 weeks post-treatment, and were less effective than PDC/HDC Ac at 1 week post-treatment. In a second series of experiments, the efficacy of PDC/HDC Ac was evaluated in both single and multiple dose regiments. One treatment group received 5 mg of PDC/HDC Ac intramuscularly each week for 4 weeks, while another treatment group received a single dose of 20 mg PDC/HDC Ac i.m. Corresponding vehicle control groups were also included. At 1 week post-treatment in the single dose group, the PDC/HDC Ac was only modestly effective, with some reduction of severity of lesions at the higher challenge doses of PIU. However, at 4 and 7 weeks post-treatment, both the incidence and the severity of the lesions at all challenge doses were reduced. In the multiple dose group, the incidence and severity of lesions are reduced at 1 week and 4 weeks post-treatment (4 weeks and 7 weeks after the initial dose) but were not significantly different from the single dose group. These findings indicate that the diacetate ester of PDC/HDC is an effective hyposensitizer to poison ivy urushiol, and that this hyposensitization can be reasonably accomplished in a single dose treatment regimen.

  20. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions.

    PubMed

    Hayward, Diane; Eikeseth, Svein; Gale, Catherine; Morgan, Sally

    2009-11-01

    This study examined progress after 1 year of treatment for children with autism who received a mean of 36 hours per week one-to-one University of California at Los Angeles Applied Behavior Analysis (UCLA ABA) treatment. Two types of service provision were compared: an intensive clinic based treatment model with all treatment personnel (N = 23), and an intensive parent managed treatment model with intensive supervision only (N = 21). A non-concurrent multiple baseline design across participants (N = 13) examined whether progress was associated with ABA treatment or confounders. Between intake and follow-up, children in both groups improved significantly on IQ, visual-spatial IQ, language comprehension, expressive language, social skills, motor skills and adaptive behaviour. There were no significant differences between the two groups on any of the measures at follow-up. Mean IQ for participants in both groups increased by 16 points between intake and follow-up. These findings are consistent with previous studies demonstrating the benefits of ABA treatment.

  1. Prognostic factors and outcome in anorexia nervosa: a follow-up study.

    PubMed

    Errichiello, Luca; Iodice, Davide; Bruzzese, Dario; Gherghi, Marco; Senatore, Ignazio

    2016-03-01

    Anorexia nervosa is an eating disorder characterized by food restriction, irrational fear of gaining weight and consequent weight loss. High mortality rates have been reported, mostly due to suicide and malnutrition. Good outcomes largely vary between 18 and 42%. We aimed to assess outcome and prognostic factors of a large group of patients with anorexia nervosa. Moreover we aimed to identify clusters of prognostic factors related to specific outcomes. We retrospectively reviewed data of 100 patients diagnosed with anorexia nervosa previously hospitalized in a tertiary level structure. Then we performed follow-up structured telephone interviews. We identified four dead patients, while 34% were clinically recovered. In univariate analysis, short duration of inpatient treatment (p = 0.003), short duration of disorder (p = 0.001), early age at first inpatient treatment (p = 0.025) and preserved insight (p = 0.029) were significantly associated with clinical recovery at follow-up. In multiple logistic regression analysis, duration of first inpatient treatment, duration of disorder and preserved insight maintained their association with outcome. Moreover multiple correspondence analysis and cluster analysis allowed to identify different typologies of patients with specific features. Notably, group 1 was characterized by two or more inpatient treatments, BMI ≤ 14, absence of insight, history of long-term inpatient treatments, first inpatient treatment ≥30 days. While group 4 was characterized by preserved insight, BMI ≥ 16, first inpatient treatment ≤14 days, no more than one inpatient treatment, no psychotropic drugs intake, duration of illness ≤4 years. We confirmed the association between short duration of inpatient treatment, short duration of disorder, early age at first inpatient treatment, preserved insight and clinical recovery. We also differentiated patients with anorexia nervosa in well-defined outcome groups according to specific clusters of prognostic factors. Our study might help clinicians to evaluate prognosis of patients with anorexia nervosa.

  2. A Powerful, Potential Outcomes Method for Estimating Any Estimand across Multiple Groups

    ERIC Educational Resources Information Center

    Pattanayak, Cassandra W.; Rubin, Donald B.; Zell, Elizabeth R.

    2013-01-01

    In educational research, outcome measures are often estimated across separate studies or across schools, districts, or other subgroups to assess the overall causal effect of an active treatment versus a control treatment. Students may be partitioned into such strata or blocks by experimental design, or separated into studies within a…

  3. The Dual Participants: A High Risk Drinking Driver Target Group.

    ERIC Educational Resources Information Center

    Kline, Michael V.; And Others

    1988-01-01

    Studied dual participants (N=2,525), multiple offender drinking driver program participants who also attend non-drinking driver alcohol treatment programs. Findings support need for drinking driver programs to be aware of high risk dual participants and for alcohol-related treatment programs to provide drinking and driving education to all dual…

  4. Botulinum toxin therapy for treatment of spasticity in multiple sclerosis: review and recommendations of the IAB-Interdisciplinary Working Group for Movement Disorders task force.

    PubMed

    Dressler, Dirk; Bhidayasiri, Roongroj; Bohlega, Saeed; Chahidi, Abderrahmane; Chung, Tae Mo; Ebke, Markus; Jacinto, L Jorge; Kaji, Ryuji; Koçer, Serdar; Kanovsky, Petr; Micheli, Federico; Orlova, Olga; Paus, Sebastian; Pirtosek, Zvezdan; Relja, Maja; Rosales, Raymond L; Sagástegui-Rodríguez, José Alberto; Schoenle, Paul W; Shahidi, Gholam Ali; Timerbaeva, Sofia; Walter, Uwe; Saberi, Fereshte Adib

    2017-01-01

    Botulinum toxin (BT) therapy is an established treatment of spasticity due to stroke. For multiple sclerosis (MS) spasticity this is not the case. IAB-Interdisciplinary Working Group for Movement Disorders formed a task force to explore the use of BT therapy for treatment of MS spasticity. A formalised PubMed literature search produced 55 publications (3 randomised controlled trials, 3 interventional studies, 11 observational studies, 2 case studies, 35 reviews, 1 guideline) all unanimously favouring the use of BT therapy for MS spasticity. There is no reason to believe that BT should be less effective and safe in MS spasticity than it is in stroke spasticity. Recommendations include an update of the current prevalence of MS spasticity and its clinical features according to classifications used in movement disorders. Immunological data on MS patients already treated should be analysed with respect to frequencies of MS relapses and BT antibody formation. Registration authorities should expand registration of BT therapy for spasticity regardless of its aetiology. MS specialists should consider BT therapy for symptomatic treatment of spasticity.

  5. An Examination of Fluoxetine for the Treatment of Selective Mutism Using a Nonconcurrent Multiple-Baseline Single-Case Design Across 5 Cases.

    PubMed

    Barterian, Justin A; Sanchez, Joel M; Magen, Jed; Siroky, Allison K; Mash, Brittany L; Carlson, John S

    2018-01-01

    This study examined the utility of fluoxetine in the treatment of 5 children, aged 5 to 14 years, diagnosed with selective mutism who also demonstrated symptoms of social anxiety. A nonconcurrent, randomized, multiple-baseline, single-case design with a single-blind placebo-controlled procedure was used. Parents and the study psychiatrist completed multiple methods of assessment including Direct Behavior Ratings and questionnaires. Treatment outcomes were evaluated by calculating effect sizes for each participant as an individual and for the participants as a group. Information regarding adverse effects with an emphasis on behavioral disinhibition and ratings of parental acceptance of the intervention was gathered. All 5 children experienced improvement in social anxiety, responsive speech, and spontaneous speech with medium to large effect sizes; however, children still met criteria for selective mutism at the end of the study. Adverse events were minimal, with only 2 children experiencing brief occurrences of minor behavioral disinhibition. Parents found the treatment highly acceptable.

  6. Comparing routine neurorehabilitation program with trunk exercises based on Bobath concept in multiple sclerosis: pilot study.

    PubMed

    Keser, Ilke; Kirdi, Nuray; Meric, Aydin; Kurne, Asli Tuncer; Karabudak, Rana

    2013-01-01

    This study compared trunk exercises based on the Bobath concept with routine neurorehabilitation approaches in multiple sclerosis (MS). Bobath and routine neurorehabilitation exercises groups were evaluated. MS cases were divided into two groups. Both groups joined a 3 d/wk rehabilitation program for 8 wk. The experimental group performed trunk exercises based on the Bobath concept, and the control group performed routine neurorehabilitation exercises. Additionally, both groups performed balance and coordination exercises. All patients were evaluated with the Trunk Impairment Scale (TIS), Berg Balance Scale (BBS), International Cooperative Ataxia Rating Scale (ICARS), and Multiple Sclerosis Functional Composite (MSFC) before and after the physiotherapy program. In group analysis, TIS, BBS, ICARS, and MSFC scores and strength of abdominal muscles were significantly different after treatment in both groups (p < 0.05). When the groups were compared, no significant differences were found in any parameters (p > 0.05). Although trunk exercises based on the Bobath concept are rarely applied in MS rehabilitation, the results of this study show that they are as effective as routine neurorehabilitation exercises. Therefore, trunk exercises based on the Bobath concept can be beneficial in MS rehabilitation programs.

  7. The effectiveness of transdermal opioid in the management multiple rib fractures: randomized clinical trial.

    PubMed

    Solak, Okan; Oz, Gürhan; Kokulu, Serdar; Solak, Ozlem; Doğan, Gökçen; Esme, Hıdır; Ocalan, Kubilay; Baki, Elif Doğan

    2013-09-01

    The most commonly observed pathology in chest traumas is rib fracture, and the most important clinical symptom is severe pain. To investigate the effectiveness of intramuscular opioid (IMO), intravenous patient-controlled analgesia (IVPCA) and the Fentanyl transdermal therapeutic system (TTS) in the management of rib fracture pain. Prospective randomized clinical trial. In our prospective and randomised study, we included 45 patients with a diagnosis of multiple rib fractures. There were three groups and intercostal nerve blockage (ICB) in the first day and oral paracetamol for five days was administered to each group as standard. In Group IMO (n=15), 4×40 mg pethidine HCl was administered to the patients, while in Group IVPCA (n=15) this was 5 μg/mL continuous intravenous fentanyl and was 50 μg fentanyl TTS in Group TTS (n=15). The demographics, injury data and vital signs of the patients were recorded. Pain was scored using Visual Analogue Scale (VAS). The pain during lying down (VASl) and mobilisation (VASm) was detected. There were no differences between the three groups regarding age, sex, the trauma pattern, the number and distribution of costal fracture localisations, the presence of additional pathology, complications, thoracal catheter and the duration of thoracal catheter. No significant difference between the groups regarding systolic and diastolic arterial tension, number of breaths and beats in a minute was observed (p>0.05). We observed an improvement in the mean VAS score after treatment in all three groups. The mean VASl score significantly decreased after treatment in each group (p<0.05). The mean VASl and VASm scores measured on the 1(st), 2(nd), 3(rd), 4(th) and 5(th) days were found to be higher in Group IMO than in Groups IVPCA and TTS; however, these differences were not statistically significant (p>0.05). In the analgesia of patients with multiple rib fractures, TTS administration with ICB showed similar effectiveness with IVPCA administration with ICB. In the management of pain due to multiple rib fractures, TTS administration is a safe, non-invasive and effective procedure.

  8. Hydrotherapy for the treatment of pain in people with multiple sclerosis: a randomized controlled trial.

    PubMed

    Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Lara-Palomo, Inmaculada; Saavedra-Hernández, Manuel; Arroyo-Morales, Manuel; Moreno-Lorenzo, Carmen

    2012-01-01

    Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P < 0.028) and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

  9. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    PubMed Central

    Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A.; Lara-Palomo, Inmaculada; Saavedra-Hernández, Manuel; Arroyo-Morales, Manuel; Moreno-Lorenzo, Carmen

    2012-01-01

    Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P < 0.028) and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients. PMID:21785645

  10. Pharmacokinetics of voriconazole after oral administration of single and multiple doses in African grey parrots (Psittacus erithacus timneh).

    PubMed

    Flammer, Keven; Nettifee Osborne, Julie A; Webb, Donna J; Foster, Laura E; Dillard, Stacy L; Davis, Jennifer L

    2008-01-01

    To determine the pharmacokinetics and safety of orally administered voriconazole in African grey parrots. 20 clinically normal Timneh African grey parrots (Psittacus erithacus timneh). In single-dose trials, 12 parrots were each administered 6, 12, and 18 mg of voriconazole/kg orally and plasma concentrations of voriconazole were determined via high-pressure liquid chromatography. In a multiple-dose trial, voriconazole (18 mg/kg) was administered orally to 6 birds every 12 hours for 9 days; a control group (2 birds) received tap water. Treatment effects were assessed via observation, clinicopathologic analyses (3 assessments), and measurement of trough plasma voriconazole concentrations (2 assessments). Voriconazole's elimination half-life was short (1.1 to 1.6 hours). Higher doses resulted in disproportional increases in the maximum plasma voriconazole concentration and area under the curve. Trough plasma voriconazole concentrations achieved in the multiple-dose trial were lower than those achieved after administration of single doses. Polyuria (the only adverse treatment effect) developed in treated and control birds but was more severe in the treatment group. In African grey parrots, voriconazole has dose-dependent pharmacokinetics and may induce its own metabolism. Oral administration of 12 to 18 mg of voriconazole/kg twice daily is a rational starting dose for treatment of African grey parrots infected with Aspergillus or other fungal organisms that have a minimal inhibitory concentration for voriconazole < or = 0.4 microg/mL. Higher doses may be needed to maintain plasma voriconazole concentrations during long-term treatment. Safety and efficacy of various voriconazole treatment regimens in this species require investigation.

  11. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis.

    PubMed

    Lúcio, Adélia Correia; Campos, Renata Martins; Perissinotto, Maria Carolina; Miyaoka, Ricardo; Damasceno, Benito Pereira; D'ancona, Carlos Arturo Levi

    2010-11-01

    Evaluate the role of pelvic floor muscle training (PFMT) on the treatment of lower urinary tract dysfunction (LUTD) in multiple sclerosis (MS) patients. In this randomized controlled trial, twenty seven female patients with a diagnosis of MS and LUTD complaints were randomized, in two groups: Treatment group (GI) (N = 13) and Sham group (GII) (N = 14). Evaluation included urodynamic study, 24-hr Pad testing, three day voiding diary and pelvic floor evaluation according to PERFECT scheme. Intervention was performed twice a week for 12 weeks in both groups. GI intervention consisted of PFMT with assistance of a vaginal perineometer. GII received a sham treatment consisted on the introduction of a perineometer inside the vagina with no contraction required. At the end of the treatment GI was complaining less about storage and voiding symptoms than GII. Furthermore, differences found between groups were: reduction of pad weight (P = 0.00) (Mean: 87,51 grams initial and 6,03 grams final in GI. 69,46 grams initial and 75,88 grams final in GII), number of pads (P = 0.01) (Mean: 3,61 initial and 2,15 final in GI. 3,42 initial and 3,28 final in GII) and nocturia events (P < 0.00) (Mean: 2,38 initial and 0,46 final in GI. 2,55 initial and 2,47 final in GII) and improvements of muscle power (P = 0.00), endurance (P < 0.00), resistance (P < 0.00) and fast contractions (P < 0.00), domains of PERFECT scheme. PFMT is an effective approach to treat LUTD in female with MS. © 2010 Wiley-Liss, Inc.

  12. Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy.

    PubMed

    Klement, R J; Hoerner-Rieber, J; Adebahr, S; Andratschke, N; Blanck, O; Boda-Heggemann, J; Duma, M; Eble, M J; Eich, H C; Flentje, M; Gerum, S; Hass, P; Henkenberens, C; Hildebrandt, G; Imhoff, D; Kahl, K H; Klass, N D; Krempien, R; Lohaus, F; Petersen, C; Schrade, E; Wendt, T G; Wittig, A; Guckenberger, M

    2018-03-03

    Stereotactic body radiotherapy (SBRT) for oligometastatic disease is characterized by an excellent safety profile; however, experiences are mostly based on treatment of one single metastasis. It was the aim of this study to evaluate safety and efficacy of SBRT for multiple pulmonary metastases. This study is based on a retrospective database of the DEGRO stereotactic working group, consisting of 637 patients with 858 treatments. Cox regression and logistic regression were used to analyze the association between the number of SBRT treatments or the number and the timing of repeat SBRT courses with overall survival (OS) and the risk of early death. Out of 637 patients, 145 patients were treated for multiple pulmonary metastases; 88 patients received all SBRT treatments within one month whereas 57 patients were treated with repeat SBRT separated by at least one month. Median OS for the total patient population was 23.5 months and OS was not significantly influenced by the overall number of SBRT treatments or the number and timing of repeat SBRT courses. The risk of early death within 3 and 6 months was not increased in patients treated with multiple SBRT treatments, and no grade 4 or grade 5 toxicity was observed in these patients. In appropriately selected patients, synchronous SBRT for multiple pulmonary oligometastases and repeat SBRT may have a comparable safety and efficacy profile compared to SBRT for one single oligometastasis. Copyright © 2018 Elsevier B.V. All rights reserved.

  13. Therapeutic effects of multiple nutritional supplements on the hypertensive indices of cardiovascular distress

    NASA Astrophysics Data System (ADS)

    Okereke, Emmanuel O.

    2000-09-01

    This quasi-experiment study examined the therapeutic effects of multiple nutritional supplements on the hypertensive indices of cardiovascular distress. By utilizing drug interventions that reduced cardiovascular distress through changes in the hypertensive indices, previous studies have shown that improvements in life expectancy, lowering of health care costs in later years, and reduction in all-cause mortality were achieved. In fact, individuals without risk factors or with low risk factors for cardiovascular disease in young adulthood or middle age were healthier, had a greater life expectancy, and incurred lower health care costs in later years. The hypertensive indices of interest include elevated heart rate (HR), systolic blood pressure (Ps), diastolic blood pressure (PD), mean arterial blood pressure (MABP), pulse pressure (PP), and mechanical disadvantages of the heart MDH. Mechanical disadvantage of the heart is a term that has been developed for the purposes of this study. The alternative hypotheses for this study proposed to show a significant change in the relevant hypertensive indices of cardiovascular distress in volunteers after a minimum of 45 days treatment with multiple nutritional supplements. The target population was all middle-aged (30 to 65 years) volunteer hypertensives in Nigeria (West Africa), who were randomly assigned to either the experimental group or control group, controlling for individuals who were on any form of medication, smokers, alcoholics, and those who were pregnant or on contraceptives. Treatment involved multiple doses of the various vitamins, minerals, essential amino acids, essential fatty acids, and accessory nutrients in their complementary combinations that influence various levels of cardiovascular function. After 45 days of treatment, the differences between the mean sores of the experimental group and control group on Ps, PD, MABP, and PP were found to be statistically significant, at p ≤ .05 cut-off level for rejecting the null hypothesis for each dependent variable on a one-tailed student's t test. The same results were not demonstrated for HR and MDH. In summary, the therapeutic effects of multiple nutritional supplements on the hypertensive indices of cardiovascular distress could provide a cost-effective, safe, healthy, and reliable way of preventing cardiovascular disease.

  14. Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

    PubMed

    Rixen, Dieter; Steinhausen, Eva; Sauerland, Stefan; Lefering, Rolf; Maegele, Marc G; Bouillon, Bertil; Grass, Guido; Neugebauer, Edmund A M

    2016-01-25

    Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of "damage control orthopedics" (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains. Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.

  15. 77 FR 64768 - Regulations Regarding the Application of Section 172(h) Including Consolidated Groups; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... treatment of multiple step plans for the acquisition of stock and CERTs involving members of a consolidated... language ``Service, 1111 Constitution Avenue NW.,'' is corrected to read ``Service, 1111 Constitution... from the bottom of the page, the language ``return group; (4) application of these'' is corrected to...

  16. Evaluation of Bully-Proofing Your School as an Elementary School Antibullying Intervention

    ERIC Educational Resources Information Center

    Menard, Scott; Grotpeter, Jennifer K.

    2014-01-01

    Bully-Proofing Your School (BPYS), a school-based intervention program designed to reduce bullying and school violence, is evaluated for its impact on bullying and related aggressive behaviors in a multiple nonequivalent control group, pretest-posttest design with ex ante selection of treatment and comparison groups. Outcome measures included…

  17. Increasing the Athletic Group Play of Children with Autism

    ERIC Educational Resources Information Center

    Miltenberger, Catherine A.; Charlop, Marjorie H.

    2014-01-01

    A multiple baseline design across three children with autism and within child across activity was used to assess the effects of interventions designed to teach children with autism to play two common athletic group games, handball and 4-square. Treatment consisted of two phases. In Phase I, athletic skills training, the children participated in…

  18. Vorinostat or placebo in combination with bortezomib in patients with multiple myeloma (VANTAGE 088): a multicentre, randomised, double-blind study.

    PubMed

    Dimopoulos, Meletios; Siegel, David S; Lonial, Sagar; Qi, Junyuan; Hajek, Roman; Facon, Thierry; Rosinol, Laura; Williams, Catherine; Blacklock, Hilary; Goldschmidt, Hartmut; Hungria, Vania; Spencer, Andrew; Palumbo, Antonio; Graef, Thorsten; Eid, Joseph E; Houp, Jennifer; Sun, Linda; Vuocolo, Scott; Anderson, Kenneth C

    2013-10-01

    We aimed to assess efficacy and tolerability of vorinostat in combination with bortezomib for treatment of patients with relapsed or refractory multiple myeloma. In our randomised, double-blind, placebo-controlled, phase 3 trial, we enrolled adults (≥18 years) at 174 university hospitals in 31 countries worldwide. Eligible patients had to have non-refractory multiple myeloma that previously responded to treatment (one to three regimens) but were currently progressing, ECOG performance statuses of 2 or less, and no continuing toxic effects from previous treatment. We excluded patients with known resistance to bortezomib. We randomly allocated patients (1:1) using an interactive voice response system to receive 21 day cycles of bortezomib (1·3 mg/m(2) intravenously on days 1, 4, 8, and 11) in combination with oral vorinostat (400 mg) or matching placebo once-daily on days 1-14. We stratified patients by baseline tumour stage (International Staging System stage 1 or stage ≥2), previous bone-marrow transplantation (yes or no), and number of previous regimens (1 or ≥2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed adverse events in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number 00773747. Between Dec 24, 2008, and Sept 8, 2011, we randomly allocated 317 eligible patients to the vorinostat group (315 of whom received at least one dose) and 320 to the placebo group (all of whom received at least one dose). Median PFS was 7·63 months (95% CI 6·87-8·40) in the vorinostat group and 6·83 months (5·67-7·73) in the placebo group (hazard ratio [HR] 0·77, 95% CI 0·64-0·94; p=0·0100). 312 (99%) of 315 patients in the vorinostat group and 315 (98%) of 320 patients in the placebo group had adverse events (300 [95%] adverse events in the vorinostat group and 282 [88%] in the control group were regarded as related to treatment). The most common grade 3-4 adverse events were thrombocytopenia (143 [45%] patients in the vorinostat group vs 77 [24%] patients in the placebo group), neutropenia (89 [28%] vs 80 [25%]), and anaemia (53 [17%] vs 40 [13%]). Although the combination of vorinostat and bortezomib prolonged PFS relative to bortezomib and placebo, the clinical relevance of the difference in PFS between the two groups is not clear. Different treatment schedules of bortezomib and vorinostat might improve tolerability and enhance activity. Merck. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. Treatment Efficacy of Multiple Family Therapy for Chinese Families of Children with Attention Deficit Hyperactivity Disorder.

    PubMed

    Ma, Joyce L C; Lai, Kelly Y C; Xia, Lily Li Li

    2018-06-01

    The treatment efficacy of multiple family therapy (MFT) for Chinese families of children with attention deficit hyperactivity disorder (ADHD) has not been studied in the past. In this paper, the effect of MFT on different aspects of the lives of the parents in the experimental group (n = 61) was compared with the effect of only the psychoeducational talks on parents in the control group (n = 53). The results of a MANOVA have shown that by the time they reached the posttreatment phase, the parents who had completed the full 42 hours of the MFT program perceived their children's ADHD symptoms as being less serious and less pathological than they had originally thought compared to the parents in the control group. The effect of MFT on parent-child relationships, parenting stress, parental efficacy, hope, and perceived social support was statistically insignificant. Contributions and limitations of our study are discussed. © 2017 Family Process Institute.

  20. Evaluation of Gastrointestinal Leakage in Multiple Enteric Inflammation Models in Chickens.

    PubMed

    Kuttappan, Vivek A; Vicuña, Eduardo A; Latorre, Juan D; Wolfenden, Amanda D; Téllez, Guillermo I; Hargis, Billy M; Bielke, Lisa R

    2015-01-01

    Enteric inflammation models can help researchers' study methods to improve health and performance and evaluate various growth promoters and dietary formulations targeted to improve performance in poultry. Oral administration of fluorescein isothiocyanate-dextran (FITC-d; 3-5 kDa) and its pericellular mucosal epithelial leakage are an established marker to evaluate enteric inflammation in multiple species. The present study evaluated different methods to induce gut inflammation in poultry based on FITC-d leakage. Four independent experiments were completed with different inflammation treatment groups, and serum FITC-d and/or retention of FITC-d in GI tract were determined. In experiment 1 (n = 10 birds/treatment, broilers, processed at 14 days), groups included control (CON), dextran sodium sulfate (DSS; drinking water at 0.75%) and feed restriction (FRS; 24 h before processing). Experiment 2 (n = 14 birds/treatment, leghorns, processed at 7 days) included CON, DSS, FRS, and rye-based diet (RBD). In experiments 3 and 4 (n = 15 birds/treatment, broilers, processed at 7 days), groups were CON, DSS, high fat diet (HFD), FRS, and RBD. In all experiments, FRS and RBD treatments showed significantly higher serum FITC-d levels compared to the respective CON. This indicates that FRS and RBD results in disruption of the intact barrier of the gastrointestinal tract (GIT), resulting in increased gut permeability. DSS and HFD groups showed elevation of serum FITC-d levels although the magnitude of difference from respective CON was inconsistent between experiments. FRS was the only treatment which consistently showed elevated retention of FITC-d in GIT in all experiments. The results from present studies showed that FRS and RBD, based on serum FITC-d levels, can be robust models to induce gut leakage in birds in different age and species/strains.

  1. The Children’s Attention-deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study: Methodology for Conducting a Trial of Telemental Health in Multiple Underserved Communities

    PubMed Central

    Stoep, Ann Vander; Myers, Kathleen

    2013-01-01

    Background Children who live in non-metropolitan communities are underserved by evidence-based mental health care and underrepresented in clinical trials of mental health services. Telemental Health (TMH), the use of videoteleconferencing (VTC) to provide care that is usually delivered in person, shows promise for helping to rectify these service disparities. Purpose The Children’s ADHD Telemental Health Treatment Study (CATTS) is a randomized controlled trial designed to test the effectiveness of TMH in providing treatment to children diagnosed with attention-deficit hyperactivity disorder (ADHD) who are living in underserved communities. In this paper we describe the methodologies we developed for the trial and lessons learned. Methods Children ages 5.5-12 years of age with ADHD were referred to CATTS by their primary care physicians (PCP’s). The test intervention group (Group A) received six telepsychiatry sessions followed by in-person caregiver behavioral training delivered by a local therapist who was trained and supervised remotely. A secure website was used to support decision-making by the telepsychiatrists, to facilitate real-time collaboration between the telepsychiatrists and community therapists, and communication with the PCP’s. The control group (Group B) received a single telepsychiatry consultation followed by treatment with their PCP’s who implemented the telepsychiatrists’ recommendations at their discretion. Caregivers completed five sets of questionnaires about children’s symptoms and functioning and their own levels of distress. Older children (aged 10-12 years) completed questionnaires about their symptoms and functioning. Teachers completed ADHD rating scales. Questionnaires were completed online through a secure portal from personal computers. Results Eighty-eight PCP’s in seven communities referred the 223 children who participated in the trial. Attrition was low (3%). Children in Group A completed an average of 5.3 of 6 scheduled sessions; 96% of children in Group B completed their telepsychiatry consultation. Parents in both groups completed an average of 4.8 of 5 assessments. Telepsychiatrists and therapists showed high adherence to treatment protocols. Lessons Learned TMH proved to be a viable means of providing evidence-based pharmacological services to children and of training local therapists in evidence-based caregiver behavioral management. Recruitment was enhanced by offering the control group a telepsychiatry consultation. To meet recruitment targets across multiple dispersed sites, we developed community-specific strategies. A dedicated scheduler was a critical staff role to coordinate the multiple sites, sessions, and clinicians. Trial implementation was easier with sites that shared an electronic medical record system with our research hub. Conclusions The CATTS study used methods and procedures to optimize inclusion of children living in multiple dispersed and underserved areas. These experiences should advance the development of technologies needed to recruit underserved populations into research projects with the goal of reducing disparities in access to quality mental health care. PMID:23897950

  2. Perfectionism Group Treatment for Eating Disorders in an Inpatient, Partial Hospitalization, and Outpatient Setting.

    PubMed

    Levinson, Cheri A; Brosof, Leigh C; Vanzhula, Irina A; Bumberry, Laura; Zerwas, Stephanie; Bulik, Cynthia M

    2017-11-01

    Perfectionism is elevated in individuals with eating disorders and is posited to be a risk factor, maintaining factor, and treatment barrier. However, there has been little literature testing the feasibility and effectiveness of perfectionism interventions in individuals specifically with eating disorders in an open group format. In the current study, we tested the feasibility of (a) a short cognitive behavioural therapy for perfectionism intervention delivered in an inpatient, partial hospitalization, and outpatient for eating disorders setting (combined N = 28; inpatient n = 15; partial hospital n = 9; outpatient n = 4), as well as (b) a training for disseminating the treatment in these settings (N = 9). Overall, we found that it was feasible to implement a perfectionism group in each treatment setting, with both an open and closed group format. This research adds additional support for the implementation of perfectionism group treatment for eating disorders and provides information on the feasibility of implementing such interventions across multiple settings. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

  3. Efficacy of Human Umbilical Stem Cells Cultured on Polylactic/ Polyglycolic Acid Membrane in the Treatment of Multiple Gingival Recession Defects: a Randomized Controlled Clinical Study

    PubMed Central

    Zanwar, Kushal; Kumar Ganji, Kiran; Bhongade, Manohar L

    2017-01-01

    Statement of the Problem: Recently allogenic mesenchymal stem cells are proposed to have multipotential progenitor cell capabilities to differentiate into cementoblasts, osteoblasts, and periodontal ligament fibroblasts. Purpose: The aim of the present study was to compare the efficacy of human umbilical stem cells cultured on polylactic acid (PLA), polyglycolic acid (PGA) membrane with PLA/PGA membrane alone in the treatment of multiple gingival recession defects. Materials and Method: A total number of 14 cases of multiple gingival recession (Miller’s Class I or II) located in the anterior region were randomly selected and divided into test (stem cells in combination with PLA/PGA membrane) and control group (PLA/PGA membrane alone). Clinical parameters including gingival recession, probing pocket depth, clinical attachment level, and width of keratinized gingiva were recorded at baseline, and at 6 months postoperative. Results: At baseline, there was 2.28 mm and 2.14mm mean gingival recession at 16 sites and 14 sites in test and control groups respectively. At 6 months post-surgery, test group showed 1.57 mm mean reduction of gingival recession indicating 66% root coverage, while the control group showed 1.24mm mean reduction of gingival recession indicating 57% root coverage. Conclusion: In the present study, the stem cell with PLA/PGA membrane showed significantly higher mean root coverage compared to only PLA/PGA membrane group. PMID:28620633

  4. Natalizumab Modifies Catecholamines Levels Present in Patients with Relapsing- Remitting Multiple Sclerosis.

    PubMed

    Escribano, Begona M; Aguilar-Luque, Macarena; Bahamonde, Carmen; Conde, Cristina; Lillo, Rafael; Sanchez-Lopez, Fernando; Giraldo, Ana I; Cruz, Antonio H; Luque, Evelio; Gascon, Felix; Aguera, Eduardo; Tunez, Isaac

    2016-01-01

    The main aim of this study was to verify the effect of natalizumab on the levels of circulating catecholamines and indolamine and their possible relation with MS. For this purpose, 12 healthy individuals (control group) and 12 relapsing-remitting multiple sclerosis patients (RR-MS) were selected. The patients were treated with 300 mg of natalizumab during 56 weeks (1 dose/4 weeks) (MS-56). This selection was based on the McDonalds revision criterion and scheduled to star treatment with natalizumab. Blood samples were taken before treatment (basal level) and after 56 weeks of using natalizumab. Melatonin was measured in serum and in plasma, catecholamines (dopamine, epinephrine, and norepinephrine), carbonylated proteins, 8-hydroxy-2'deoxyguanosine (8OH-dG) and the ratio reduced glutathione/oxidised glutathione (GSH/GSSG). The epinephrine and dopamine levels diminished in the basal group with respect to the control and did not recover normal levels with the treatment. The melatonin was decreased in RR-MS patients and went back to its normal levels with natalizumab. Norepinephrine was increased in RR-MS and decreased in MS-56 until it equalled the control group. Natalizumab normalizes altered melatonin and norepinephrine levels in MS.

  5. A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis.

    PubMed

    Kiropoulos, Litza A; Kilpatrick, Trevor; Holmes, Alex; Threader, Jennifer

    2016-12-07

    To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis. The current study presents a pilot, parallel group randomized controlled trial (RCT) with an allocation ratio of 1:1 conducted in a large research and teaching hospital in Melbourne, Australia. 30 individuals with a mean age of 36.93 years (SD = 9.63) who were newly diagnosed with multiple sclerosis (MS) (X = 24.87 months, SD = 15.61) were randomized to the CBT intervention (n = 15) or treatment as usual (TAU) (n = 15). The primary outcome was level of depressive symptoms using the Beck Depression Inventory-II (BDI-II). Secondary outcomes were level of anxiety, fatigue and pain impact, sleep quality, coping, acceptance of MS illness, MS related quality of life, social support, and resilience. Tertiary outcomes were acceptability and adherence to the intervention. Large between group treatment effects were found for level of depressive symptoms at post and at 20 weeks follow-up (d = 1.66-1.34). There were also small to large group treatment effects for level of anxiety, fatigue and pain impact, sleep quality, MS related quality of life, resilience, and social support at post and at 20 weeks follow-up (d = 0.17-1.63). There were no drop-outs and participants completed all treatment modules. All participants reported the treatment as 'very useful', and most (73.4%) reported that the intervention had addressed their problems 'completely'. These data suggest that the tailored early intervention is appropriate and clinically effective for the treatment of depressive symptoms in those newly diagnosed with MS. A larger RCT comparing the CBT intervention with an active comparative treatment with longer term follow-up and cost effectiveness analyses is warranted. The pilot trial has been retrospectively registered on 28/04/2016 with the ISRCTN registry (trial ID ISRCTN10423371).

  6. Improvement in C-reactive protein and advanced glycosylation end-products in poorly controlled diabetics is independent of glucose control.

    PubMed

    Md Isa, S H; Najihah, I; Nazaimoon, W M Wan; Kamarudin, N A; Umar, N A; Mat, N H; Khalid, B A K

    2006-04-01

    We studied the efficacy of four different treatment regimens (sulphonylurea and metformin+/-acarbose versus glimepiride and rosiglitazone versus glimepiride and bedtime NPH insulin versus multiple actrapid and NPH insulin injections) in poorly controlled type 2 diabetes subjects on hs-CRP, VCAM-1 and AGE at 4, 8 and 12 weeks of treatment. Multiple insulin injections rapidly improved HbA(1c) by 0.6+/-0.9% (p<0.005), 1.2+/-1.3% (p<0.0005) and 1.3+/-1.4% (p<0.0005) at week 4, at week 8 and week 12, respectively. Subjects who continued their existing combination treatment of sulphonylurea, metformin+/-acarbose also showed a significant reduction in HbA(1c) (p<0.05). Although effective in reducing glycemic parameters, there was no reduction in CRP levels in either treatment group. The treatment regimen consisting of rosiglitazone and glimepiride significantly lowered hs-CRP by -2.6 (3.9) mg/L (p<0.05) at week 12 in spite of no improvement in blood glucose. AGE improved in all groups irrespective of type of treatment, glycaemic control and CRP levels. Our data indicate rapid glycaemic control alone does not necessarily result in improvement in markers of inflammation in type 2 diabetes patients.

  7. Ovulation induction with clomiphene citrate and metformin in women with polycystic ovary syndrome.

    PubMed

    Leanza, V; Coco, L; Grasso, F; Leanza, G; Zarbo, G; Palumbo, M

    2014-06-01

    Polycystic ovary syndrome (PCOS) is one of the most common causes of ovulatory infertility. It is an endocrine disorders characterized by a high level of male hormones (androgens) and frequent anovulatory cycles associated with multiple ovarian microcysts. The aim of this paper was to evaluate effects of a Clomiphene citrate alone versus a combined treatment (Metformin and Clomiphene citrate). A total of 60 women with PCOS and infertility were evaluated. Inclusions criteria were: age 26-34 years, nulliparity, above 3 years of sterility, multiple ovarian microcysts, BMI>27.5, oligomenorrhea/amenorrhea, hyperandrogenism and normal male fertility. Four patients were excluded (renal damage 2, tubal occlusion 1 and Pelvic Inflammatory Disease 1). The remaining 56 were divided into 2 groups: group A were inducted with Clomiphene Citrate alone, while group B were inducted with Clomiphene citrate and Metformin. In group A we obtained ovulation in 20 women (71.4%), 8 pregnancies (28.5%) and one (3.5%) spontaneous abortion. In group B we obtained ovulation in 24 women (85.7%), 15 pregnancies (53.5%) and no spontaneous abortions. Combined treatment was found to be more effective (53.5) in improving pregnancy rate compared to monotherapy (28.5%).

  8. Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.

    PubMed

    Haupts, Michael; Vila, Carlos; Jonas, Anna; Witte, Kerstin; Álvarez-Ossorio, Lourdes

    2016-01-01

    Sativex® (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients. Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2). Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID ≥18% improvement vs. baseline) and clinically important difference (CID, ≥30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history. THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history. © 2016 S. Karger AG, Basel.

  9. Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.

    PubMed

    Warke, Kim; Al-Smadi, Jamal; Baxter, David; Walsh, Deirdre M; Lowe-Strong, Andrea S

    2006-01-01

    This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population.

  10. Experiences in anti-tuberculosis treatment in patients with multiple previous treatments and its impact on drug resistant tuberculosis epidemics

    PubMed Central

    Xu, Biao; Zhao, Qi; Hu, Yi; Shi, Ying; Wang, Weibing; Diwan, Vinod K.

    2014-01-01

    Background Tuberculosis (TB) patients with a history of multiple anti-TB treatments are the ‘neglected’ group to the free anti-TB treatment policy in China. Objective To understand the experiences of TB patients with multiple previous treatments with regard to bacteriological diagnosis and treatment regimens, especially for second-line anti-TB drugs, and how this might influence the risks of multidrug and extensively drug-resistant TB (M/XDR-TB). Design A cross-sectional study was conducted in 10 county/district TB clinics in five provinces of China. The study participants were TB patients that had at least two previous treatment episodes that lasted longer than 1 month each. Face-to-face interviews and drug susceptibility testing (DST) were conducted with the consenting participants. Results A total of 328 TB patients were recruited. The proportion of multidrug-resistant tuberculosis (MDR-TB) was 58.2% in the 287 DST-confirmed patients. Forty-two percent of the patients did not complete their first treatment course. About 23.8% of the participants had a history of taking second-line drugs, and more than 77.8% of them were treated in county TB dispensaries where only sputum microscopy was applied. Multivariate analysis found that the use of second-line drugs was significantly associated with frequency of previous treatments (p<0.01), but not with drug resistance profiles of patients. Conclusions Patients with multiple previous treatments are at extremely high risk of MDR-TB in China. The unregulated use of second-line drugs bring about the threat of XDR-TB epidemic. DST-guided treatment and strict regulations of anti-TB treatment should be assured for the high-risk TB patients for the prevention and control of M/XDR-TB. PMID:25138531

  11. Effects of dextromethorphan/quinidine on auditory event-related potentials in multiple sclerosis patients with pseudobulbar affect.

    PubMed

    Haiman, Guy; Pratt, Hillel; Miller, Ariel

    2009-10-01

    The purpose of this study was to characterize the brain activity and associated cortical structures involved in pseudobulbar affect (PBA), a condition characterized by uncontrollable episodes of laughing and/or crying in patients with multiple sclerosis before and after treatment with dextromethorphan/quinidine (DM/Q). Behavioral responses and event-related potentials (ERPs) in response to subjectively significant and neutral verbal stimuli were recorded from 2 groups: 6 multiple sclerosis patients with PBA before (PBA-preTx) and after (PBA-DM/Q) treatment with DM/Q and 6 healthy control (HC) subjects. Statistical nonparametric mapping comparisons of ERP source current density distributions between groups were conducted for subjectively significant and neutral stimuli separately before and after treatment with DM/Q. Treatment with DM/Q had a normalizing effect on the behavioral responses of PBA patients. Event-related potential waveform comparisons of PBA-preTx and PBA-DM/Q with HC, for both neutral and subjectively significant stimuli, revealed effects on early ERP components. Comparisons between PBA-preTx and HC, in response to subjectively significant stimuli, revealed both early and late effects. Source analysis comparisons between PBA-preTx and PBA-DM/Q indicated distinct activations in areas involved in emotional processing and high-level and associative visual processing in response to neutral stimuli and in areas involved in emotional, somatosensory, primary, and premotor processing in response to subjectively significant stimuli. In most cases, stimuli evoked higher current density in PBA-DM/Q compared with the other groups. In conclusion, differences in brain activity were observed before and after medication. Also, DM/Q administration resulted in normalization of behavioral and electrophysiological measures.

  12. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis.

    PubMed

    Montalban, X; Gold, R; Thompson, A J; Otero-Romero, S; Amato, M P; Chandraratna, D; Clanet, M; Comi, G; Derfuss, T; Fazekas, F; Hartung, H P; Havrdova, E; Hemmer, B; Kappos, L; Liblau, R; Lubetzki, C; Marcus, E; Miller, D H; Olsson, T; Pilling, S; Selmaj, K; Siva, A; Sorensen, P S; Sormani, M P; Thalheim, C; Wiendl, H; Zipp, F

    2018-02-01

    Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus. © 2018 European Academy of Neurology and European Committee of Treatment of Research in Multiple Sclerosis.

  13. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial.

    PubMed

    Lind, Marcus; Polonsky, William; Hirsch, Irl B; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Schwarz, Erik; Ólafsdóttir, Arndís Finna; Frid, Anders; Wedel, Hans; Ahlén, Elsa; Nyström, Thomas; Hellman, Jarl

    2017-01-24

    The majority of individuals with type 1 diabetes do not meet recommended glycemic targets. To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections. Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections. Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks. Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied. Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia. Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Further research is needed to assess clinical outcomes and longer-term adverse effects. clinicaltrials.gov Identifier: NCT02092051.

  14. Cross-reactions to desoximetasone and mometasone furoate in a patient with multiple topical corticosteroid allergies.

    PubMed

    Donovan, Jeffrey C H; Dekoven, Joel G

    2006-09-01

    A 60-year-old man developed a bullous contact dermatitis after topical corticosteroid treatment of dermatitis on his lower leg. Subsequent patch testing showed cross-reactions to numerous group B and group D corticosteroids as well as cross-reactions to group C desoximetasone and group D1 mometasone furoate. His patch-test result was negative for the group A corticosteroids hydrocortisone and tixocortol pivalate. We discuss the uncommon finding of cross-reactions to desoximetasone and mometasone furoate.

  15. Risk of symptomatic heterotopic ossification following plate osteosynthesis in multiple trauma patients: an analysis in a level-1 trauma centre

    PubMed Central

    Zeckey, Christian; Hildebrand, Frank; Mommsen, Philipp; Schumann, Julia; Frink, Michael; Pape, Hans-Christoph; Krettek, Christian; Probst, Christian

    2009-01-01

    Background Symptomatic heterotopic ossification (HO) in multiple trauma patients may lead to follow up surgery, furthermore the long-term outcome can be restricted. Knowledge of the effect of surgical treatment on formation of symptomatic heterotopic ossification in polytrauma is sparse. Therefore, we test the effects of surgical treatment (plate osteosynthesis or intramedullary nailing) on the formation of heterotopic ossification in the multiple trauma patient. Methods We retrospectively analysed prospectively documented data of blunt multiple trauma patients with long bone fractures which were treated at our level-1 trauma centre between 1997 and 2005. Patients were distributed to 2 groups: Patients treated by intramedullary nails (group IMN) or plate osteosynthesis (group PLATE) were compared. The expression and extension of symptomatic heterotopic ossifications on 3-6 months follow-up x-rays in antero-posterior (ap) and lateral views were classified radiologically and the maximum expansion was measured in millimeter (mm). Additionally, ventilation time, prophylactic medication like indomethacine and incidence and correlation of head injuries were analysed. Results 101 patients were included in our study, 79 men and 22 women. The fractures were treated by intramedullary nails (group IMN n = 50) or plate osteosynthesis (group PLATE n = 51). Significantly higher radiologic ossification classes were detected in group PLATE (2.9 ± 1.3) as compared to IMN (2.2 ± 1.1; p = 0.013). HO size in mm ap and lateral showed a tendency towards larger HOs in the PLATE group. Additionally PLATE group showed a higher rate of articular fractures (63% vs. 28% in IMN) while IMN demonstrated a higher rate of diaphyseal fractures (72% vs. 37% in PLATE; p = 0.003). Ventilation time, indomethacine and incidence of head injuries showed no significant difference between groups. Conclusion Fracture care with plate osteosynthesis in polytrauma patients is associated with larger formations of symptomatic heterotopic ossifications (HO) while intramedullary nailing was associated with a higher rate of remote HO. For future fracture care of multiply injured patients these facts may be considered by the responsible surgeon. PMID:19825174

  16. A Multiple Indicators Multiple Causes (MIMIC) model of internal barriers to drug treatment in China.

    PubMed

    Qi, Chang; Kelly, Brian C; Liao, Yanhui; He, Haoyu; Luo, Tao; Deng, Huiqiong; Liu, Tieqiao; Hao, Wei; Wang, Jichuan

    2015-03-01

    Although evidence exists for distinct barriers to drug abuse treatment (BDATs), investigations of their inter-relationships and the effect of individual characteristics on the barrier factors have been sparse, especially in China. A Multiple Indicators Multiple Causes (MIMIC) model is applied for this target. A sample of 262 drug users were recruited from three drug rehabilitation centers in Hunan Province, China. We applied a MIMIC approach to investigate the effect of gender, age, marital status, education, primary substance use, duration of primary drug use, and drug treatment experience on the internal barrier factors: absence of problem (AP), negative social support (NSS), fear of treatment (FT), and privacy concerns (PC). Drug users of various characteristics were found to report different internal barrier factors. Younger participants were more likely to report NSS (-0.19, p=0.038) and PC (-0.31, p<0.001). Compared to other drug users, ice users were more likely to report AP (0.44, p<0.001) and NSS (0.25, p=0.010). Drug treatment experiences related to AP (0.20, p=0.012). In addition, differential item functioning (DIF) occurred in three items when participant from groups with different duration of drug use, ice use, or marital status. Individual characteristics had significant effects on internal barriers to drug treatment. On this basis, BDAT perceived by different individuals could be assessed before tactics were utilized to successfully remove perceived barriers to drug treatment. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Trichuris suis ova therapy in relapsing multiple sclerosis is safe but without signals of beneficial effect.

    PubMed

    Voldsgaard, A; Bager, P; Garde, E; Åkeson, P; Leffers, A M; Madsen, C G; Kapel, C; Roepstorff, A; Thamsborg, S M; Melbye, M; Siebner, H; Søndergaard, H B; Sellebjerg, F; Sørensen, P Soelberg

    2015-11-01

    An observational study has suggested that relapsing-remitting multiple sclerosis patients with helminth infections have lower disease activity and progression than uninfected multiple sclerosis patients. To evaluate the safety and efficacy on MRI activity of treatment with TSO in relapsing MS. The study was an open-label, magnetic resonance imaging assessor-blinded, baseline-to-treatment study including ten patients with relapsing forms of multiple sclerosis. Median (range) age was 41 (24-55) years, disease duration 9 (4-34) years, Expanded Disability Status Scale score 2.5 (1-5.0), and number of relapses within the last two years 3 (2-5). Four patients received no disease modifying therapy, while six patients received IFN-β. After an observational period of 8 weeks, patients received 2500 ova from the helminth Trichuris suis orally every second week for 12 weeks. Patients were followed with serial magnetic resonance imaging, neurological examinations, laboratory safety tests and expression of immunological biomarker genes. Treatment with Trichuris suis orally was well-tolerated apart from some gastrointestinal symptoms. Magnetic resonance imaging revealed 6 new or enlarged T2 lesions in the run-in period, 7 lesions in the early period and 21 lesions in the late treatment period. Two patients suffered a relapse before treatment and two during treatment. Eight patients developed eosinophilia. The expression of cytokines and transcription factors did not change. In a small group of relapsing multiple sclerosis patients, Trichuris suis oral therapy was well tolerated but without beneficial effect. © The Author(s), 2015.

  18. Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study.

    PubMed

    Lisi, Franco; Carfagna, Piero; Oliva, Mario Montanino; Rago, Rocco; Lisi, Rosella; Poverini, Roberta; Manna, Claudio; Vaquero, Elena; Caserta, Donatella; Raparelli, Valeria; Marci, Roberto; Moscarini, Massimo

    2012-07-23

    Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n=50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients.

  19. Pre-treatment red blood cell distribution width provides prognostic information in multiple myeloma.

    PubMed

    Zhou, Di; Xu, Peipei; Peng, Miaoxin; Shao, Xiaoyan; Wang, Miao; Ouyang, Jian; Chen, Bing

    2018-06-01

    The red blood cell distribution width (RDW), a credible marker for abnormal erythropoiesis, has recently been studied as a prognostic factor in oncology, but its role in multiple myeloma (MM) hasn't been thoroughly investigated. We performed a retrospective study in 162 patients with multiple myeloma. Categorical parameters were analyzed using Pearson chi-squared test. The Mann-Whitney and Wilcoxon tests were used for group comparisons. Comparisons of repeated samples data were analyzed with the general linear model repeated-measures procedure. The Kaplan-Meier product-limit method was used to determine OS and PFS, and the differences were assessed by the log-rank test. High RDW baseline was significantly associated with indexes including haemoglobin, bone marrow plasma cell infiltration, and cytogenetics risk stratification. After chemotherapy, the overall response rate (ORR) decreased as RDW baseline increased. In 24 patients with high RDW baseline, it was revealed RDW value decreased when patients achieved complete remission (CR), but increased when the disease progressed. The normal-RDW baseline group showed both longer overall survival (OS) and progression-free survival (PFS) than the high-RDW baseline group. Our study suggests pre-treatment RDW level is a prognostic factor in MM and should be regarded as an important parameter for assessment of therapeutic efficiency. Copyright © 2018. Published by Elsevier B.V.

  20. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta.

    PubMed

    Wynn, Daniel; Kaufman, Michael; Montalban, Xavier; Vollmer, Timothy; Simon, Jack; Elkins, Jacob; O'Neill, Gilmore; Neyer, Lauri; Sheridan, James; Wang, Chungchi; Fong, Alice; Rose, John W

    2010-04-01

    Daclizumab, a humanised monoclonal antibody, reduced multiple sclerosis disease activity in previous non-randomised studies. We aimed to assess whether daclizumab reduces disease activity in patients with active relapsing multiple sclerosis who are receiving interferon beta treatment. We did a phase 2, randomised, double-blind, placebo-controlled study at 51 centres in the USA, Canada, Germany, Italy, and Spain. Patients with active relapsing multiple sclerosis who were taking interferon beta were randomly assigned to receive add-on subcutaneous daclizumab 2 mg/kg every 2 weeks (interferon beta and high-dose daclizumab group), daclizumab 1 mg/kg every 4 weeks (interferon beta and low-dose daclizumab group), or interferon beta and placebo for 24 weeks. The randomisation scheme was generated by Facet Biotech. All patients and assessors were masked to treatment with the exception of Facet Biotech bioanalysts who prepared data for the data safety monitoring board or generated pharmacokinetic or pharmacodynamic data, a drug accountability auditor, and the site pharmacist. The primary endpoint was total number of new or enlarged gadolinium contrast-enhancing lesions measured on brain MRI scans every 4 weeks between weeks 8 and 24. Effects of daclizumab on prespecified subsets of lymphocytes and quantitative T-cell proliferative response were assessed in an exploratory pharmacodynamic substudy. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00109161. From May, 2005, to March, 2006, 288 patients were assessed for eligibility, and 230 were randomly assigned to receive interferon beta and high-dose daclizumab (n=75), interferon beta and low-dose daclizumab (n=78), or interferon beta and placebo (n=77). The adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 4.75 in the interferon beta and placebo group compared with 1.32 in the interferon beta and high-dose daclizumab group (difference 72%, 95% CI 34% to 88%; p=0.004) and 3.58 in the interferon beta and low-dose daclizumab group (25%, -76% to 68%; p=0.51). In the pharmacodynamic substudy, daclizumab was not associated with significant changes in absolute numbers of T cells, B cells, or natural killer cells, or T-cell proliferative response compared with interferon beta alone. The number of CD56(bright) natural killer cells was seven to eight times higher in both daclizumab groups than in the interferon beta and placebo group (interferon beta and low-dose daclizumab group p=0.002; interferon beta and high-dose daclizumab group p<0.0001). Common adverse events were equally distributed across groups. Add-on daclizumab treatment reduced the number of new or enlarged gadolinium contrast-enhancing lesions compared with interferon beta alone and might reduce multiple sclerosis disease activity to a greater extent than interferon beta alone. Facet Biotech and Biogen Idec. 2010 Elsevier Ltd. All rights reserved.

  1. Long-term Outcome of Multiple Small-diameter Drilling Decompression Combined with Hip Arthroscopy versus Drilling Alone for Early Avascular Necrosis of the Femoral Head.

    PubMed

    Li, Ji; Li, Zhong-Li; Zhang, Hao; Su, Xiang-Zheng; Wang, Ke-Tao; Yang, Yi-Meng

    2017-06-20

    Avascular necrosis of femoral head (AVNFH) typically presents in the young adults and progresses quickly without proper treatments. However, the optimum treatments for early stage of AVNFH are still controversial. This study was conducted to evaluate the therapeutic effects of multiple small-diameter drilling decompression combined with hip arthroscopy for early AVNFH compared to drilling alone. This is a nonrandomized retrospective case series study. Between April 2006 and November 2010, 60 patients (98 hips) with early stage AVNFH participated in this study. The patients underwent multiple small-diameter drilling decompression combined with hip arthroscopy in 26 cases/43 hips (Group A) or drilling decompression alone in 34 cases/55 hips (Group B). Patients were followed up at 6, 12, and 24 weeks, and every 6 months thereafter. Radiographs were taken at every follow-up, Harris scores were recorded at the last follow-up, the paired t-test was used to compare the postoperative Harris scores. Surgery effective rate of the two groups was compared using the Chi-square test. All patients were followed up for an average of 57.6 months (range: 17-108 months). Pain relief and improvement of hip function were assessed in all patients at 6 months after the surgery. At the last follow-up, Group A had better outcome with mean Harris' scores improved from 68.23 ± 11.37 to 82.07 ± 2.92 (t = -7.21, P = 0.001) than Group B with mean Harris' scores improved from 69.46 ± 9.71 to 75.79 ± 4.13 (t = -9.47, P = 0.037) (significantly different: t = -2.54, P = 0.017). The total surgery effective rate was also significantly different between Groups A and B (86.0% vs. 74.5%; χ2 = 3.69, P = 0.02). For early stage of AVNFH, multiple small-diameter drilling decompression combined with hip arthroscopy is more effective than drilling decompression alone.

  2. Anterior midline point stop device (AMPS) in the treatment of myogenous TMDs: comparison with the stabilization splint and control group.

    PubMed

    Al Quran, Firas A M; Kamal, Mudar S

    2006-06-01

    Two occlusal splints, the full-arch stabilization splint and the anterior midline point stop (AMPS) device, were evaluated for their efficiency in relieving myogenous temporomandibular disorders (TMD). One hundred and fourteen patients with myogenous TMD were distributed into 3 groups. The first group was treated with the AMPS device, the second with the stabilization splint, and the third group was the control group. Pain intensity was scored using the visual analogue scale before treatment and 1 month and 3 months after treatment. Statistical Package for the Social Sciences (SPSS, Chicago, Ill) and multiple comparisons tests were used to compare results before and after treatment and to compare the groups. The use of AMPS device in the first group resulted in a significant improvement after 1 month and 3 months (P < or = .001) and showed a 56.66% pain reduction. A significant improvement was also noticed in the second group (P = .001) with a 47.71% pain reduction. Although pain reduction percentage appeared more in the first group, this was not statistically significant. There was a highly significant difference between groups treated with both kinds of splints and the control group. It was concluded that both types of occlusal splints are beneficial to patients with myogenous TMD.

  3. Surgical excision and immediate postoperative radiotherapy versus cryotherapy and intralesional steroids in the management of keloids: a prospective clinical trial.

    PubMed

    Emad, Maryam; Omidvari, Shapour; Dastgheib, Ladan; Mortazavi, Afshin; Ghaem, Haleh

    2010-01-01

    To compare the efficacy and tolerability of surgical excision and radiotherapy with those of cryotherapy and intralesional steroid treatment of keloids. Twenty-six patients with a total of 76 keloids were enrolled in this study. Nineteen patients with 44 keloids underwent surgical excision combined with immediate 12-Gy irradiation (group A) while the remaining 9 patients with 32 keloids received multiple sessions of intralesional steroid treatment after cryotherapy which continued until flattening of lesion(s) occurred (group B). Two patients were included in both treatment groups. All patients were followed up at regular intervals for at least 1 year. In both treatment groups, keloids responded well without any major side effect. While patients of group A were all satisfied, those of group B (with a mean number of treatment sessions of 5.84 +/- 2.51) experienced more side effects, a more prolonged course, a higher recurrence rate and less satisfaction. This study showed that surgery plus immediate postoperative irradiation was an effective and relatively safe choice for treatment of keloids. Although cryotherapy combined with intralesional steroids was associated with more side effects and higher relapse rates, it could be a good choice for small and newly formed keloids. Copyright 2010 S. Karger AG, Basel.

  4. Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers with PTSD

    DTIC Science & Technology

    2014-06-01

    Type I alpha should be discussed in relation to the findings for multiple primary hypothesis tests conducted . o The hypotheses indicated in the...memory during exposure. However, there is limited research on the effectiveness of either treatment with active duty military personnel and there are...VRE or were assigned to a minimal attention wait list. All assessments were conducted by a psychologist blind to treatment group. External

  5. Population based study of rates of multiple pregnancies in Denmark, 1980-94.

    PubMed Central

    Westergaard, T.; Wohlfahrt, J.; Aaby, P.; Melbye, M.

    1997-01-01

    OBJECTIVE: To study trends in multiple pregnancies not explained by changes in maternal age and parity patterns. DESIGN: Trends in population based figures for multiple pregnancies in Denmark studied from complete national records on parity history and vital status. POPULATION: 497,979 Danish women and 803,019 pregnancies, 1980-94. MAIN OUTCOME MEASURES: National rates of multiple pregnancies, infant mortality, and stillbirths controlled for maternal age and parity. Special emphasis on primiparous women > or = 30 years of age, who are most likely to undergo fertility treatment. RESULTS: The national incidence of multiple pregnancies increased 1.7-fold during 1980-94, the increase primarily in 1989-94 and almost exclusively in primiparous women aged > or = 30 years, for whom the adjusted population based twinning rate increased 2.7-fold and the triplet rate 9.1-fold. During 1989-94, the adjusted yearly increase in multiple pregnancies for these women was 19% (95% confidence interval 16% to 21%) and in dizygotic twin pregnancies 25% (21% to 28%). The proportion of multiple births among infant deaths in primiparous women > or = 30 years increased from 11.5% to 26.9% during the study period. The total infant mortality, however, did not increase for these women because of a simultaneous significant decrease in infant mortality among singletons. CONCLUSIONS: A relatively small group of women has drastically changed the overall national rates of multiple pregnancies. The introduction of new treatments to enhance fertility has probably caused these changes and has also affected the otherwise decreasing trend in infant mortality. Consequently, the resources, both economical and otherwise, associated with these treatments go well beyond those invested in specific fertility enhancing treatments. PMID:9080993

  6. Injection of demineralized bone matrix with bone marrow concentrate improves healing in unicameral bone cyst.

    PubMed

    Di Bella, Claudia; Dozza, Barbara; Frisoni, Tommaso; Cevolani, Luca; Donati, Davide

    2010-11-01

    Unicameral bone cysts are benign lesions that usually spontaneously regress with skeletal maturity; however, the high risk of pathologic fractures often justifies treatment that could reinforce a weakened bone cortex. Various treatments have been proposed but there is no consensus regarding the best procedure. We compared the healing rates and failures of two methods of cure based on multiple injections of corticosteroid or a single injection of demineralized bone matrix (DBM) in association with bone marrow concentrate (BMC). We retrospectively reviewed 184 patients who had one of the two treatments for unicameral bone cysts with cortical erosion. Clinical records were reviewed for treatment failures and radiographs for healing in all patients. The minimum followup was 12 months for the Steroids Group (mean, 48 months; range, 12-120 months) and 12 months for the DBM + BMC Group (mean, 20 months; range, 12-28 months). After one treatment we observed a lower healing rate of cysts treated with multiple injections of steroids compared with the healing after the first injection of DBM + BMC (21% versus 58%, respectively). At last followup, 38% healed with steroids and 71% with DBM + BMC. The rate of failure after one steroid injection was higher than after a single injection of BDM + BMC (63% versus 24%, respectively). We observed no difference in fracture rates after treatment between the two groups. A single injection of DBM added with autologous bone marrow concentrate appears to provide a higher healing rate with a lower number of failures compared with a single injection of steroids.

  7. Correlates of motivation to change in pathological gamblers completing cognitive-behavioral group therapy.

    PubMed

    Gómez-Peña, Mónica; Penelo, Eva; Granero, Roser; Fernández-Aranda, Fernando; Alvarez-Moya, Eva; Santamaría, Juan José; Moragas, Laura; Neus Aymamí, Maria; Gunnard, Katarina; Menchón, José M; Jimenez-Murcia, Susana

    2012-07-01

    The present study analyzes the association between the motivation to change and the cognitive-behavioral group intervention, in terms of dropouts and relapses, in a sample of male pathological gamblers. The specific objectives were as follows: (a) to estimate the predictive value of baseline University of Rhode Island Change Assessment scale (URICA) scores (i.e., at the start of the study) as regards the risk of relapse and dropout during treatment and (b) to assess the incremental predictive ability of URICA scores, as regards the mean change produced in the clinical status of patients between the start and finish of treatment. The relationship between the URICA and the response to treatment was analyzed by means of a pre-post design applied to a sample of 191 patients who were consecutively receiving cognitive-behavioral group therapy. The statistical analysis included logistic regression models and hierarchical multiple linear regression models. The discriminative ability of the models including the four URICA scores regarding the likelihood of relapse and dropout was acceptable (area under the receiver operating haracteristic curve: .73 and .71, respectively). No significant predictive ability was found as regards the differences between baseline and posttreatment scores (changes in R(2) below 5% in the multiple regression models). The availability of useful measures of motivation to change would enable treatment outcomes to be optimized through the application of specific therapeutic interventions. © 2012 Wiley Periodicals, Inc.

  8. Comparison of clinical features and 3-month treatment response among three different choroidal thickness groups in polypoidal choroidal vasculopathy.

    PubMed

    Kong, Mingui; Kim, Sung Min; Ham, Don-Il

    2017-01-01

    Eyes with polypoidal choroidal vasculopathy (PCV) were recently reported to have various choroidal thickness, and choroidal thickness might be associated with visual outcome in the treatment of many retinal disorders. The range of subfoveal choroidal thickness (SFCT), clinical features, and 3-month treatment response among three groups having different range of SFCT were investigated in PCV eyes. In 78 treatment-naïve eyes with PCV, SFCT was measured using optical coherence tomography. Eyes were classified into thin, medium, and thick groups, using mean and one standard deviation of SFCT. Clinical features and imaging findings were compared among the three groups. Some eyes were treated with three consecutive monthly injection of anti-vascular endothelial growth factor (VEGF) as an initial treatment. They were also classified into three thickness groups, and the short-term post-treatment improvement in visual acuity and central retinal thickness were compared among groups. The mean SFCT was 271.9 ± 135.6 μm. Twelve, 53, and 13 eyes were classified into thin (<136.3 μm), medium (136.3-407.5 μm), and thick (>407.5 μm) groups, respectively. The thin group showed older age, lower visual acuity, and a higher prevalence of fundus tessellation than the other two groups (P <0.05). In multiple linear regression analyses, baseline BCVA was correlated with baseline SFCT. Forty-six eyes completed three consecutive anti-VEGF treatments. The thin group showed no visual improvement after treatment (P = 0.141), unlike the other two groups showing visual improvement (P<0.05). Eyes with PCV have a broad range of SFCT, and PCV eyes with a thin choroid manifest worse visual function than eyes with a medium or thick choroid.

  9. The influence of cognitive dysfunction on benefit from learning and memory rehabilitation in MS: A sub-analysis of the MEMREHAB trial.

    PubMed

    Chiaravalloti, Nancy D; DeLuca, John

    2015-10-01

    This study examined the influence of processing speed (PS) on benefit from treatment with the modified Story Memory Technique(©) (mSMT), a behavioral intervention shown to improve new learning and memory in multiple sclerosis (MS). This double-blind, placebo-controlled, randomized clinical trial included 85 participants with clinically definite MS, 45 assigned to the treatment group and 40 to the placebo-control group. Participants completed baseline and follow-up neuropsychological assessment. The present study represents a post-hoc analysis to examine the role of PS on treatment efficacy. The treatment group showed a significantly improved CVLT learning slope relative to the placebo group post-treatment, after co-varying PS performance. SDMT performance was a significant predictor of benefit from mSMT treatment, beyond group assignment. Post-hoc analysis indicated a significant correlation between the SDMT and overall cognition, indicating that the SDMT may be serving as a proxy for overall cognitive impairment. Performance on measures of cognitive dysfunction aside from learning and memory impact the benefit of mSMT treatment. While the current study focused on PS as a critical factor, PS may be serving as a marker for generalized cognitive dysfunction. Implications for cognitive rehabilitation in MS are discussed. © The Author(s), 2015.

  10. Local infiltration of the surgical wounds with levobupivacaine, dexibuprofen, and norepinephrine to reduce postoperative pain: A randomized, vehicle-controlled, and preclinical study.

    PubMed

    Gao, Zongwen; Cui, Feng; Cao, Xuemei; Wang, Dejun; Li, Xiao; Li, Tianzuo

    2017-08-01

    Postoperative pain may lead to poor wound healing, insomnia, and increased postoperative hospitalization. The objective of the study was to explore the effect of local infiltration of the surgical wound with levobupivacaine, dexibuprofen, and norepinephrine in postoperative pain. A randomized, parallel experimental design was applied in 40, 9-11-week-old Wister albino rats. A laparotomy was performed in all groups of 10 rats each. During surgery, the sutured muscle was infiltrated with 40μL of a normal saline (vehicle group), a normal saline containing 0.25% v/v levobupivacaine, 0.2mg/mL dexibuprofen, and 0.1mg/mL norepinephrine (treatment group) before skin closure. The same combination (negative control group) and a 10-fold higher dose (positive control group) were administered systematically. Rat Grimace Scale scores, based on facial expression, 24h after suturing of the tissues, histopathology and tensile strength of the surgical wound, two weeks after suturing of the tissues were measured. The one-way ANOVA and the two-tailed paired t-test/the Dunnett multiple comparisons test were used to compare the Rat Grimace Scale scores for pain within the group and between groups. The Kruskal-Wallis test and the one-way ANOVA/the Dunnett multiple comparisons test were used to compare the histopathology study and the tensile strength. The difference for statistical analysis was considered significant at the 95% of confidence level. The mean Rat Grimace Scale score at 24h for the treatment, negative control, and positive control groups was 1.945 (p=0.0025; q=3.257), 1.1 (p=0.1), and 1.95 (p=0.0021 q=3.547) respectively. The reduction in postoperative pain started within 1h after the suturing of the tissues in the treatment group. There were significant difference for epidermal and dermal regeneration (p=0.043), granulation tissue thickness (p=0.025), and angiogenesis (p=0.002) between treatment group and vehicle group. Tensile strength for the treatment group was 0.82±0.013N/cm 2 (p=0.003; q=5.231). The rapid infiltration of surgical wounds with a low-dose levobupivacaine, dexibuprofen, and norepinephrine may reduce postoperative pain and increase the wound regeneration process. Copyright © 2017. Published by Elsevier Masson SAS.

  11. Statistical approaches to assessing single and multiple outcome measures in dry eye therapy and diagnosis.

    PubMed

    Tomlinson, Alan; Hair, Mario; McFadyen, Angus

    2013-10-01

    Dry eye is a multifactorial disease which would require a broad spectrum of test measures in the monitoring of its treatment and diagnosis. However, studies have typically reported improvements in individual measures with treatment. Alternative approaches involve multiple, combined outcomes being assessed by different statistical analyses. In order to assess the effect of various statistical approaches to the use of single and combined test measures in dry eye, this review reanalyzed measures from two previous studies (osmolarity, evaporation, tear turnover rate, and lipid film quality). These analyses assessed the measures as single variables within groups, pre- and post-intervention with a lubricant supplement, by creating combinations of these variables and by validating these combinations with the combined sample of data from all groups of dry eye subjects. The effectiveness of single measures and combinations in diagnosis of dry eye was also considered. Copyright © 2013. Published by Elsevier Inc.

  12. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial.

    PubMed

    Dimopoulos, Meletios A; Goldschmidt, Hartmut; Niesvizky, Ruben; Joshua, Douglas; Chng, Wee-Joo; Oriol, Albert; Orlowski, Robert Z; Ludwig, Heinz; Facon, Thierry; Hajek, Roman; Weisel, Katja; Hungria, Vania; Minuk, Leonard; Feng, Shibao; Zahlten-Kumeli, Anita; Kimball, Amy S; Moreau, Philippe

    2017-10-01

    The phase 3 ENDEAVOR trial was a head-to-head comparison of two proteasome inhibitors in patients with relapsed or refractory multiple myeloma. Progression-free survival was previously reported to be significantly longer with carfilzomib administered in combination with dexamethasone than with bortezomib and dexamethasone in an interim analysis. The aim of this second interim analysis was to compare overall survival between the two treatment groups. ENDEAVOR was a phase 3, open-label, randomised controlled trial in patients with relapsed or refractory multiple myeloma. Patients were recruited from 198 hospitals and outpatient clinics in 27 countries in Europe, North America, South America, and the Asia-Pacific region. Patients were aged 18 years or older, had relapsed or refractory multiple myeloma, and had received between one and three previous lines of therapy. Patients were randomly assigned (1:1) to receive carfilzomib and dexamethasone (carfilzomib group) or bortezomib and dexamethasone (bortezomib group) through a blocked randomisation scheme (block size of four), stratified by International Staging System stage, previous lines of treatment, previous proteasome inhibitor therapy, and planned route of bortezomib delivery if assigned to the bortezomib group. Carfilzomib (20 mg/m 2 on days 1 and 2 of cycle 1; 56 mg/m 2 thereafter) was given as a 30-min intravenous infusion on days 1, 2, 8, 9, 15, and 16 of 28-day cycles; bortezomib (1·3 mg/m 2 ) was given as an intravenous bolus or subcutaneous injection on days 1, 4, 8, and 11 of 21-day cycles. Dexamethasone (20 mg oral or intravenous infusion) was given on days 1, 2, 8, 9, 15, 16, 22, and 23 in the carfilzomib group and on days 1, 2, 4, 5, 8, 9, 11, and 12 in the bortezomib group. The primary endpoint of ENDEAVOR, progression-free survival, has been previously reported. A stratified log-rank test was used to compare overall survival between treatment groups for this prospectively planned second interim analysis. Efficacy assessments were done in all randomly assigned patients (the intention-to-treat population) and the safety analysis included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01568866, and is no longer enrolling patients. Between June 20, 2012, and June 30, 2014, 1096 patients were assessed for eligibility, of whom 929 were randomly assigned (464 to the carfilzomib group and 465 to the bortezomib group). The cutoff date for this prespecified interim analysis was Jan 3, 2017. Median overall survival was 47·6 months (95% CI 42·5-not evaluable) in the carfilzomib group versus 40·0 months (32·6-42·3) in the bortezomib group (hazard ratio 0·791 [95% CI 0·648-0·964], one-sided p=0·010). Grade 3 or worse adverse events were reported in 377 (81%) of 463 patients in the carfilzomib group and 324 (71%) of 456 patients in the bortezomib group, and serious adverse events in 273 (59%) patients in the carfilzomib group and 182 (40%) in the bortezomib group. The most frequent grade 3 or worse adverse events were anaemia (76 [16%] of 463 patients in the carfilzomib group vs 46 [10%] of 456 patients in the bortezomib group), hypertension (67 [15%] vs 15 [3%]), pneumonia (42 [9%] vs 39 [9%]), thrombocytopenia (41 [9%] vs 43 [9%]), fatigue (31 [7%] vs 35 [8%]), dyspnoea (29 [6%] vs ten [2%]), decreased lymphocyte count (29 [6%] vs nine [2%]), diarrhoea (18 [4%] vs 39 [9%]), and peripheral neuropathy (six [1%] vs 28 [6%]). Treatment-related deaths occurred in five (1%) of 463 patients in the carfilzomib group (pneumonia [n=2], interstitial lung disease [n=1], septic shock [n=1], and unknown [n=1]) and two (<1%) of 456 patients in the bortezomib group (cardiac arrest [n=1] and pneumonia [n=1]). Carfilzomib provided a significant and clinically meaningful reduction in the risk of death compared with bortezomib. To our knowledge, carfilzomib is the first and only multiple myeloma treatment that extends overall survival in the relapsed setting over the current standard of care. This study is informative for deciding which proteasome inhibitor to use for treating this disease. Onyx Pharmaceuticals Inc, an Amgen Inc subsidiary. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Fundamentals in the management of multiple myeloma.

    PubMed

    Fadilah, S A W

    2010-09-01

    Progress in our understanding of multiple myeloma and its treatment has resulted in a more tailored approach to patient management, with different therapeutics regimens for different patient populations. The decision to initiate therapy depends primarily on the presence of symptoms which has to balance the chance of tumor clearance and against the risks of treatment related mortality. Selection of appropriate initial treatment should be based primarily on patient's characteristics (biologic age, co-morbidities), the disease characteristics (tumor burden and genetic risk profile) and the expected toxicity profile of the different regimens. When treatment begins, in younger transplant eligible patients the goal is to achieve high quality responses with intensive therapies as the quality of response appears to be important surrogates for long-term outcome. In the majority of myeloma patients in whom intensive treatment is not an option due to advanced age and co-morbidities, treatment should emphasize on optimal disease control to obtain symptomatic relief and to maintain a satisfactory quality of life. The introduction of novel agents has substantially changed the treatment paradigm of this otherwise incurable disease. The utilization of these drugs has moved from relapse setting to the front line setting and has benefited all patient groups. Because of these rapid developments and many treatment options we need good quality clinical studies to guide clinical practice in the management of patients with multiple myeloma. This review presents an update on current concepts of diagnosis and treatment of patients with multiple myeloma and provides recommendations on tailored therapies with particular reference to the local practice. The information presented herein may be used by the health care providers caring for myeloma patients as a guideline to counsel patients to understand their disease and the treatment better.

  14. Incidence of Postoperative Pain after Single Visit and Two Visit Root Canal Therapy: A Randomized Controlled Trial

    PubMed Central

    Joshi, Sonal B.; Bhagwat, S.V; Patil, Sanjana A

    2016-01-01

    Introduction Root Canal Treatment (RCT) has become a mainstream procedure in dentistry. A successful RCT is presented by absence of clinical signs and symptoms in teeth without any radiographic evidence of periodontal involvement. Completing this procedure in one visit or multiple visits has long been a topic of discussion. Aim To evaluate the incidence of postoperative pain after root canal therapy performed in single visit and two visits. Material and Methods An unblinded/ open label randomized controlled trial was carried out in the endodontic department of the Dental Institute, where 78 patients were recruited from the regular pool of patients. A total of 66 maxillary central incisors requiring root canal therapy fulfilled the inclusion and exclusion criteria. Using simple randomization by biased coin randomization method, the selected patients were assigned into two groups: group A (n=33) and group B (n=33). Single visit root canal treatment was performed for group A and two visit root canal treatment for group B. Independent sample t-test was used for statistical analysis. Results Thirty three patients were allotted to group A where endodontic treatment was completed in single visit while 33 patients were allotted to group B where endodontic treatment was completed in two visits. One patient dropped-out from Group A. Hence in Group A, 32 patients were analysed while in Group B, 33 patients were analysed. After 6 hours, 12 hours and 24 hours of obturation, pain was significantly higher in Group B as compared to Group A. However, there was no significant difference in the pain experienced by the patients 48 hours after treatment in both the groups. Conclusion Incidence of pain after endodontic treatment being performed in one-visit or two-visits is not significantly different. PMID:27437339

  15. Combination of robot-assisted and conventional body-weight-supported treadmill training improves gait in persons with multiple sclerosis: a pilot study.

    PubMed

    Ruiz, Jennifer; Labas, Michele P; Triche, Elizabeth W; Lo, Albert C

    2013-12-01

    The majority of persons with multiple sclerosis (MS) experience problems with gait, which they characterize as highly disabling impairments that adversely impact their quality of life. Thus, it is crucial to develop effective therapies to improve mobility for these individuals. The purpose of this study was to determine whether combination gait training, using robot-assisted treadmill training followed by conventional body-weight-supported treadmill training within the same session, improved gait and balance in individuals with MS. This study tested combination gait training in 7 persons with MS. The participants were randomized into the immediate therapy group (IT group) or the delayed therapy group (DT group). In phase I of the trial, the IT group received treatment while the DT group served as a concurrent comparison group. In phase II of the trial, the DT group received treatment identical to the treatment received by the IT group in phase I. Outcome measures included the 6-Minute Walk Test (6MWT), the Timed 25-Foot Walk Test, velocity, cadence, and the Functional Reach Test (FRT). Nonparametric statistical techniques were used for analysis. Combination gait training resulted in significantly greater improvements in the 6MWT for the IT group (median change = +59 m) compared with Phase I DT group (median change = -8 m) (P = 0.08) and FRT (median change = +3.3 cm in IT vs -0.8 cm in the DT group phase I; P = 0.03). Significant overall pre-post improvements following combination gait training were found in 6MWT (+32 m; P = 0.02) and FRT (+3.3 cm; P = 0.06) for IT and Phase II DT groups combined. Combination of robot with body-weight-supported treadmill training gait training is feasible and improved 6MWT and FRT distances in persons with MS.Video Abstract available (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A62) for more insights from the authors.

  16. [The overall assessment of psychological well - being of patients with multiple sclerosis after the application of physical therapy. Part 2].

    PubMed

    Kubsik-Gidlewska, Anna; Klimkiewicz, Robert; Klimkiewicz, Paulina; Janczewska, Katarzyna; Jankowska, Agnieszka; Nowakowski, Tomasz; Woldańska-Okońska, Marta

    2017-01-01

    Multiple sclerosis is a chronic demyelinating disease of the central nervous system, which results a progressive disability. The disease reduces the quality of life of patients, changes the general health perceptions, and also limits performing social roles because of emotional problems. Evaluation of the impact of the methods of rehabilitation to improve the mental health of patients with multiple sclerosis, and also to change individual parameters included in the overall assessment of mental health. The study was conducted in 2010-2014 at the Department of Physical Medicine and Rehabilitation in Lodz. The study included 120 patients with multiple sclerosis. Patients were classified into 4 test groups: in the first was used the laser, in the second - laser and magnetostimulation, in the third - kinesiotherapy, and in the fourth - magnetostimulation. The tests were carried out three times. To evaluate the quality of life was used Quality of Life Questionnaire (MSQOL-54), analyzed the overall assessment of mental health. The improvement in a range of parameters, an overall assessment of the quality of mental health has allowed to get a better overall psychological well-being. ,There was oserved a statistically significant difference at the level of p<0.001 between groups in 4/5 investigated parameters, statistically significant differences weren't obserwed at the evaluation of cognitive functions. The greatest improvement was observed in Group II and Group IV. In the examination it was confirmed an effectiveness of physical treatment, such a the laser radiation and magnetostimulation. Synergism of both methods in their biological activity, allows for evoke of hysteresis fenomenon, resulting in the maintenance of the treatment effects after cessation of rehabilitation. Applying the classical kinesiotherapy only doesn't allow to get long-term effects.

  17. Role of endoscopic retrograde cholangiopancreatography in the management of benign biliary strictures: What’s new?

    PubMed Central

    Ferreira, Rosa; Loureiro, Rui; Nunes, Nuno; Santos, António Alberto; Maio, Rui; Cravo, Marília; Duarte, Maria Antónia

    2016-01-01

    Benign biliary strictures comprise a heterogeneous group of diseases. The most common strictures amenable to endoscopic treatment are post-cholecystectomy, post-liver transplantation, related to primary sclerosing cholangitis and to chronic pancreatitis. Endoscopic treatment of benign biliary strictures is widely used as first line therapy, since it is effective, safe, noninvasive and repeatable. Endoscopic techniques currently used are dilation, multiple plastic stents insertion and fully covered self-expandable metal stents. The main indication for dilation alone is primary sclerosing cholangitis related strictures. In the vast majority of the remaining cases, temporary placement of multiple plastic stents with/without dilation is considered the treatment of choice. Although this approach is effective, it requires multiple endoscopic sessions due to the short duration of stent patency. Fully covered self-expandable metal stents appear as a good alternative to plastic stents, since they have an increased radial diameter, longer stent patency, easier insertion technique and similar efficacy. Recent advances in endoscopic technique and various devices have allowed successful treatment in most cases. The development of novel endoscopic techniques and devices is still ongoing. PMID:26962404

  18. A multi-stage drop-the-losers design for multi-arm clinical trials.

    PubMed

    Wason, James; Stallard, Nigel; Bowden, Jack; Jennison, Christopher

    2017-02-01

    Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cause problems when applying for funding as the cost will also be generally highly variable. This motivates a type of design that provides the efficiency advantages of a group-sequential multi-arm multi-stage design, but has a fixed sample size. One such design is the two-stage drop-the-losers design, in which a number of experimental treatments, and a control treatment, are assessed at a prescheduled interim analysis. The best-performing experimental treatment and the control treatment then continue to a second stage. In this paper, we discuss extending this design to have more than two stages, which is shown to considerably reduce the sample size required. We also compare the resulting sample size requirements to the sample size distribution of analogous group-sequential multi-arm multi-stage designs. The sample size required for a multi-stage drop-the-losers design is usually higher than, but close to, the median sample size of a group-sequential multi-arm multi-stage trial. In many practical scenarios, the disadvantage of a slight loss in average efficiency would be overcome by the huge advantage of a fixed sample size. We assess the impact of delay between recruitment and assessment as well as unknown variance on the drop-the-losers designs.

  19. A qualitative study of methamphetamine users' perspectives on barriers and facilitators of drug abstinence.

    PubMed

    Herbeck, Diane M; Brecht, Mary-Lynn; Christou, Dayna; Lovinger, Katherine

    2014-01-01

    To better understand methamphetamine (MA) use patterns and the process of recovery, qualitative interviews were conducted with adult MA users (n = 20), comparing a sample that received substance abuse treatment with those who had not received treatment. Respondents provided detailed information on why and how they changed from use to abstinence and factors they considered to be barriers to abstinence. Audio recordings and transcripts were reviewed for common themes. Participants reported a range of mild/moderate to intensely destructive problems, including loss of important relationships and profound changes to who they felt they were at their core; e.g., "I didn't realize how dark and mean I was … I was like a different person." Initial abstinence was often facilitated by multiple external forces (e.g., drug testing, child custody issues, prison, relocation), but sustained abstinence was attributed to shifts in thinking and salient realizations about using. The treatment group reported using more and different resources to maintain their abstinence than the no-treatment group. Findings indicate individualized interventions and multiple, simultaneous approaches and resources were essential in reaching stable abstinence. Understanding long-term users' experiences with MA use, addiction, and abstinence can inform strategies for engaging and sustaining MA users in treatment and recovery.

  20. A Qualitative Study of Methamphetamine Users’ Perspectives on Barriers and Facilitators of Drug Abstinence

    PubMed Central

    Herbeck, Diane M.; Brecht, Mary-Lynn; Christou, Dayna; Lovinger, Katherine

    2014-01-01

    To better understand methamphetamine (MA) use patterns and the process of recovery, qualitative interviews were conducted with adult MA users (n=20), comparing a sample that received substance abuse treatment with those who had not received treatment. Respondents provided detailed information on why and how they changed from use to abstinence, and factors they considered to be barriers to abstinence. Audio recordings and transcripts were reviewed for common themes. Participants reported a range of mild/moderate to intensely destructive problems, including loss of important relationships and profound changes to who they felt they were at their core, e.g., “I didn’t realize how dark and mean I was... I was like a different person.” Initial abstinence was often facilitated by multiple external forces (e.g., drug testing, child custody issues, prison, relocation), but sustained abstinence was attributed to shifts in thinking and salient realizations about using. The treatment group reported using more and different resources to maintain their abstinence than the no treatment group. Findings indicate individualized interventions and multiple, simultaneous approaches and resources were essential in reaching stable abstinence. Understanding long-term users’ experiences with MA use, addiction and abstinence can inform strategies for engaging and sustaining MA users in treatment and recovery. PMID:25052880

  1. Long-term multiple risk factor interventions in Japanese elderly diabetic patients: the Japanese Elderly Diabetes Intervention Trial--study design, baseline characteristics and effects of intervention.

    PubMed

    Araki, Atsushi; Iimuro, Satoshi; Sakurai, Takashi; Umegaki, Hiroyuki; Iijima, Katsuya; Nakano, Hiroshi; Oba, Kenzo; Yokono, Koichi; Sone, Hirohito; Yamada, Nobuhiro; Ako, Junya; Kozaki, Koichi; Miura, Hisayuki; Kashiwagi, Atsunori; Kikkawa, Ryuichi; Yoshimura, Yukio; Nakano, Tadasumi; Ohashi, Yasuo; Ito, Hideki

    2012-04-01

    To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups. This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients. © 2012 Japan Geriatrics Society.

  2. Effect of the cooling suit method applied to individuals with multiple sclerosis on fatigue and activities of daily living.

    PubMed

    Özkan Tuncay, Fatma; Mollaoğlu, Mukadder

    2017-12-01

    To determine the effects of cooling suit on fatigue and activities of daily living of individuals with multiple sclerosis. Fatigue is one of the most common symptoms in people with multiple sclerosis and adversely affects their activities of daily living. Studies evaluating fatigue associated with multiple sclerosis have reported that most of the fatigue cases are related to the increase in body temperature and that cooling therapy is effective in coping with fatigue. This study used a two sample, control group design. The study sample comprised 75 individuals who met the inclusion criteria. Data were collected with study forms. After the study data were collected, cooling suit treatment was administered to the experimental group. During home visits paid at the fourth and eighth weeks after the intervention, the aforementioned scales were re-administered to the participants in the experimental and control groups. The analyses performed demonstrated that the severity levels of fatigue experienced by the participants in the experimental group wearing cooling suit decreased. The experimental group also exhibited a significant improvement in the participants' levels of independence in activities of daily living. The cooling suit worn by individuals with multiple sclerosis was determined to significantly improve the participants' levels of fatigue and independence in activities of daily living. The cooling suit therapy was found to be an effective intervention for the debilitating fatigue suffered by many multiple sclerosis patients, thus significantly improving their level of independence in activities of daily living. © 2017 John Wiley & Sons Ltd.

  3. Safety and benefit of curative surgical resection for esophageal squamous cell cancer associated with multiple primary cancers.

    PubMed

    Otowa, Y; Nakamura, T; Takiguchi, G; Yamamoto, M; Kanaji, S; Imanishi, T; Oshikiri, T; Suzuki, S; Tanaka, K; Kakeji, Y

    2016-03-01

    Enhancements in surgical techniques have led to improved outcomes for esophageal cancer. Recent findings have showed that esophageal cancer is frequently associated with multiple primary cancers, and surgical resection is usually complicated in such cases. The aim of this study was to clarify the clinical significance of surgery for patients with esophageal squamous cell cancer associated with multiple primary cancers. The clinical outcomes of surgical resection for esophageal cancer were compared among 79 patients with antecedent and/or synchronous cancers (Multiple cancer group) and 194 patients without antecedent and/or synchronous cancers (Single cancer group). The most common site of multiple primary cancers was the pharynx (36 patients; 29.7%), followed by the stomach (24 patients; 19.8%). The reconstruction method was more complicated in the Multiple cancer group as a result of the prolonged surgery time and increased blood loss. However, postoperative morbidity and overall survival (OS) did not differ between the two groups. After esophagectomy, metachronous cancers were observed in 26 patients, with 30 regions in total, and 93.1% were found to be curable. Sex was the only independent risk factors for developing metachronous cancer after esophagectomy. The presence of antecedent and synchronous cancers complicates the surgical resection of esophageal cancer; however, no differences were found in the OS and postoperative morbidity between the two groups. Therefore, surgical intervention should be selected as a first-line treatment. Because second primary cancers are often observed in esophageal cancer, we recommend a close follow-up using esophagogastroduodenoscopy and contrast-enhanced computed tomography. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Direct manipulation of physiological arousal in induced anxiety therapy - biofeedback approach.

    PubMed

    Sappington, A A

    1977-10-01

    This study investigated the role of physiological arousal in the affect induction phase of Induced Anxiety therapy by using biofeedback to facilitate arousal. Twenty-one college students who were suffering from free-floating anxiety were assigned randomly to one of three groups: (1) a no-treatment control group simply completed the measures before and after therapy; (2) a conventional Induced Anxiety group went through five standard Induced Anxiety sessions; and (3) biofeedback Induced Anxiety group went through a similar procedure except that biofeedback was used in the affect induction phase to facilitate heart rate increase. It was found that the biofeedback procedure did result in a greater heart rate increase during the affect induction phase arousal than did the conventional procedure (.01 level of significance), but did not facilitate subjective emotional arousal. Biofeedback Induced Anxiety resulted in a greater reduction of trait anxiety as measured by the Multiple Affect Adjective Check List than did the no-treatment group or the conventonal Induced Anxiety group. The conventional Induced Anxiety group did not differ significantly from the no-treatment control group.

  5. The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial.

    PubMed

    Schädler, Dirk; Pausch, Christine; Heise, Daniel; Meier-Hellmann, Andreas; Brederlau, Jörg; Weiler, Norbert; Marx, Gernot; Putensen, Christian; Spies, Claudia; Jörres, Achim; Quintel, Michael; Engel, Christoph; Kellum, John A; Kuhlmann, Martin K

    2017-01-01

    We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.

  6. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop.

    PubMed

    Tatakis, Dimitris N; Chambrone, Leandro; Allen, Edward P; Langer, Burton; McGuire, Michael K; Richardson, Christopher R; Zabalegui, Ion; Zadeh, Homayoun H

    2015-02-01

    Management of gingival recession defects, a common periodontal condition, using root coverage procedures is an important aspect of periodontal regenerative therapy. The goal of the periodontal soft tissue root coverage procedures group was to develop a consensus report based on the accompanying systematic review of root coverage procedures, including priorities for future research and identification of the best evidence available to manage different clinical scenarios. The group reviewed and discussed the accompanying systematic review, which covered treatment of single-tooth recession defects, multiple-tooth recession defects, and additional focused questions on relevant clinical topics. The consensus group members submitted additional material for consideration by the group in advance and at the time of the meeting. The group also identified priorities for future research. All reviewed root coverage procedures provide significant reduction in recession depth, especially for Miller Class I and II recession defects. Subepithelial connective tissue graft (SCTG) procedures provide the best root coverage outcomes. Acellular dermal matrix graft (ADMG) or enamel matrix derivative (EMD) in conjunction with a coronally advanced flap (CAF) can serve as alternatives to autogenous donor tissue. Additional research is needed to do the following: 1) assess the treatment outcomes for multiple-tooth recession defects, oral sites other than maxillary canine and premolar teeth, and Miller Class III and IV defects; 2) assess the role of patient- and site-specific factors on procedure outcomes; and 3) obtain evidence on patient-reported outcomes. Predictable root coverage is possible for single-tooth and multiple-tooth recession defects, with SCTG procedures providing the best root coverage outcomes. Alternatives to SCTG are supported by evidence of varying strength. Additional research is needed on treatment outcomes for specific oral sites. Clinical Recommendation: For Miller Class I and II single-tooth recession defects, SCTG procedures provide the best outcomes, whereas ADMG or EMD in conjunction with CAF may be used as an alternative.

  7. The effects of a multiple family therapy on adolescents with eating disorders: an outcome study.

    PubMed

    Gelin, Zoé; Fuso, Silvana; Hendrick, Stephan; Cook-Darzens, Solange; Simon, Yves

    2015-03-01

    Multiple Family Therapy (MFT) has gained increasing popularity in the treatment of eating disorders and many programs have been developed over the past decade. Still, there is little evidence in the literature on the effectiveness on MFT for treating eating disorders. The present study examines the effects of a particular model of Multiple Family Therapy on eating disorder symptoms, quality of life, and percentage of Expected Body Weight (%EBW) in adolescents with eating disorders (ED). Eighty-two adolescents with ED, aged between 11 and 19 years, were assessed before and after treatment using the Eating Disorders Inventory 2 (EDI-2), the Outcome Questionnaire 45 (OQ-45) and %EBW. Results showed a significant increase in %EBW between the beginning and end of treatment, with a large effect size. 52.4% of patients achieved an EBW above 85%. Symptoms relative to all EDI dimensions (except for bulimia) significantly decreased during treatment. The three dimensions related to quality of life assessment also improved over the course of MFT. At the end of treatment, 70.7% of patients had a total OQ-45 score below clinical significance. This study suggests that Multiple Family Therapy may benefit adolescents with eating disorders, with improvement on several outcome measures (%EBW, ED symptoms, and quality of life). However, the lack of a comparison group entails caution when drawing conclusions. © 2014 Family Process Institute.

  8. Endodontic flare-ups: comparison of incidence between single and multiple visit procedures in patients attending a Nigerian teaching hospital.

    PubMed

    Oginni, Adeleke O; Udoye, Christopher I

    2004-11-26

    BACKGROUND: Until recently the most accepted technique of doing root canal treatment stresses multiple visit procedure. Most schools also concentrated upon teaching the multi-visit concept. However, it has now been reported that the procedure of single visit treatment is advocated by at least 70% of schools in all geographical areas. It was therefore the aims of the present study to find the incidence of post-obturation flare-ups following single and multiple visit endodontic treatment procedures, and to establish the relationship between pre-operative and post-obturation pain in patients referred for endodontic therapy in a Nigerian teaching Hospital. METHODS: Data collected included pulp vitality status, the presence or absence of pre-operative, inter-appointment and post-obturation pain. Pain was recorded as none, slight, or moderate/severe. Flare-ups were defined as either patient's report of pain not controlled with over the counter medication or as increasing swelling. The patients were recalled at three specific post-obturation periods, 1st, 7th and 30th day. The presence or absence of pain, or the appropriate degree of pain was recorded for each recall visits and the interval between visits. The compiled data were analysed using chi-square where applicable. P level

  9. Parent perspectives on the decision to initiate medication treatment of attention-deficit/hyperactivity disorder.

    PubMed

    Coletti, Daniel J; Pappadopulos, Elizabeth; Katsiotas, Nikki J; Berest, Alison; Jensen, Peter S; Kafantaris, Vivian

    2012-06-01

    Despite substantial evidence supporting the efficacy of stimulant medication for children with attention-deficit/hyperactivity disorder (ADHD), adherence to stimulant treatment is often suboptimal. Applying social/cognitive theories to understanding and assessing parent attitudes toward initiating medication may provide insight into factors influencing parent decisions to follow ADHD treatment recommendations. This report describes results from formative research that used focus groups to obtain parent input to guide development of a provider-delivered intervention to improve adherence to stimulants. Participants were caregivers of children with ADHD who were given a stimulant treatment recommendation. Focus groups were recorded and transcribed verbatim. Data were analyzed by inductive, grounded theory methods as well as a deductive analytic strategy using an adapted version of the Unified Theory of Behavior Change to organize and understand parent accounts. Five groups were conducted with 27 parents (mean child age=9.35 years; standard deviation [SD]=2.00), mean time since diagnosis=3.33 years (SD=2.47). Most parents (81.5%) had pursued stimulant treatment. Inductive analysis revealed 17 attitudes facilitating adherence and 25 barriers. Facilitators included parent beliefs that medication treatment resulted in multiple functional gains and that treatment was imperative for their children's safety. Barriers included fears of personality changes and medication side effects. Complex patterns of parent adherence to medication regimens were also identified, as well as preferences for psychiatrists who were diagnostically expert, gave psychoeducation using multiple modalities, and used a chronic illness metaphor to explain ADHD. Theory-based analyses revealed conflicting expectancies about treatment risks and benefits, significant family pressures to avoid medication, guilt and concern that their children required medication, and distorted ideas about treatment risks. Parents, however, took pride in successfully pursuing efforts to manage their child behaviorally and to avoid medication when possible. Focus group data identified social, cognitive, and affective influences on treatment decision making. Results support prior research comparing family/social functioning, physician characteristics, and adherence. Findings suggest that parent attitudes to psychiatric care need to be assessed comprehensively at initial evaluation to aid the development of psychoeducational messages, and a more careful consideration about how parents interpret and respond to adherence-related questioning.

  10. The influence of individual, group, and relative self-esteem on outcome for patients undergoing group cognitive-behavioural therapy treatment.

    PubMed

    Parker, Thomas J; Page, Andrew C; Hooke, Geoff R

    2013-11-01

    Despite a strong association between individual self-esteem and treatment outcome in group cognitive-behavioural therapy (GCBT), no study has investigated how patient outcomes might be influenced by an individual's self-esteem relative to other group members. The study comprised a retrospective examination of patients' data and used a multiple regression analysis to identify predictors of treatment outcome. Patients' pre-treatment self-esteem scores were assessed on a continuum and assigned to be low, medium, or high. Therapy groups were assigned to be either low, balanced or high self-esteem groups based on averaged self-esteem scores of participants. In this study, 3,878 patients who had completed a 10-day intensive cognitive behavioural group therapy programme at a private psychiatric facility were included in the study. The Rosenberg Self-Esteem measure was chosen to assess self-esteem. The three subscales of the Depression Anxiety Stress Scales were used as the outcome measures. Patient outcomes were influenced by pre-treatment self-esteem scores, such that higher initial self-esteem was associated with better treatment outcomes. Low group self-esteem was predictive of significantly better outcomes for depression, relative to higher self-esteem groups. Additionally, the combined influence of high individual self-esteem and low group self-esteem was associated with significantly enhanced depression improvement. High self-esteem patients perform better on outcome measures following completion of GCBT. Low self-esteem groups show greater improvement in depression symptoms. Similar results for depression are achieved when patients with high self-esteem complete treatment in low self-esteem groups. © 2013 The British Psychological Society.

  11. Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial.

    PubMed

    Innerhofer, Petra; Fries, Dietmar; Mittermayr, Markus; Innerhofer, Nicole; von Langen, Daniel; Hell, Tobias; Gruber, Gottfried; Schmid, Stefan; Friesenecker, Barbara; Lorenz, Ingo H; Ströhle, Mathias; Rastner, Verena; Trübsbach, Susanne; Raab, Helmut; Treml, Benedikt; Wally, Dieter; Treichl, Benjamin; Mayr, Agnes; Kranewitter, Christof; Oswald, Elgar

    2017-06-01

    Effective treatment of trauma-induced coagulopathy is important; however, the optimal therapy is still not known. We aimed to compare the efficacy of first-line therapy using fresh frozen plasma (FFP) or coagulation factor concentrates (CFC) for the reversal of trauma-induced coagulopathy, the arising transfusion requirements, and consequently the development of multiple organ failure. This single-centre, parallel-group, open-label, randomised trial was done at the Level 1 Trauma Center in Innsbruck Medical University Hospital (Innsbruck, Austria). Patients with trauma aged 18-80 years, with an Injury Severity Score (ISS) greater than 15, bleeding signs, and plasmatic coagulopathy identified by abnormal fibrin polymerisation or prolonged coagulation time using rotational thromboelastometry (ROTEM) were eligible. Patients with injuries that were judged incompatible with survival, cardiopulmonary resuscitation on the scene, isolated brain injury, burn injury, avalanche injury, or prehospital coagulation therapy other than tranexamic acid were excluded. We used a computer-generated randomisation list, stratification for brain injury and ISS, and closed opaque envelopes to randomly allocate patients to treatment with FFP (15 mL/kg of bodyweight) or CFC (primarily fibrinogen concentrate [50 mg/kg of bodyweight]). Bleeding management began immediately after randomisation and continued until 24 h after admission to the intensive care unit. The primary clinical endpoint was multiple organ failure in the modified intention-to-treat population (excluding patients who discontinued treatment). Reversal of coagulopathy and need for massive transfusions were important secondary efficacy endpoints that were the reason for deciding the continuation or termination of the trial. This trial is registered with ClinicalTrials.gov, number NCT01545635. Between March 3, 2012, and Feb 20, 2016, 100 out of 292 screened patients were included and randomly allocated to FFP (n=48) and CFC (n=52). Six patients (four in the FFP group and two in the CFC group) discontinued treatment because of overlooked exclusion criteria or a major protocol deviation with loss of follow-up. 44 patients in the FFP group and 50 patients in the CFC group were included in the final interim analysis. The study was terminated early for futility and safety reasons because of the high proportion of patients in the FFP group who required rescue therapy compared with those in the CFC group (23 [52%] in the FFP group vs two [4%] in the CFC group; odds ratio [OR] 25·34 [95% CI 5·47-240·03], p<0·0001) and increased needed for massive transfusion (13 [30%] in the FFP group vs six [12%] in the CFC group; OR 3·04 [0·95-10·87], p=0·042) in the FFP group. Multiple organ failure occurred in 29 (66%) patients in the FFP group and in 25 (50%) patients in the CFC group (OR 1·92 [95% CI 0·78-4·86], p=0·15). Our results underline the importance of early and effective fibrinogen supplementation for severe clotting failure in multiple trauma. The available sample size in our study appears sufficient to make some conclusions that first-line CFC is superior to FFP. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Effect of special Hungarian probiotic kefir on faecal microflora.

    PubMed

    Figler, Mária; Mózsik, Gyula; Schaffer, Béla; Gasztonyi, Beáta; Acs, Pongrác; Szili, Béla; Rab, Regina; Szakály, Sándor

    2006-02-21

    To investigate the effect of a four-week consumption of a special Hungarian probiotic agent (Biofir) on the faecal microflora in human healthy subjects. The effect of Biofir with 10(6)/cm3 initial germs on the faecal microflora was studied in 120 healthy volunteers (71 females, 49 males). The traditional Russian type kefir was used as control. The various germ groups and pH values were determined in wk 2, 4 and 6. The number of all microbes increased during the 4-week probiotic treatment. The number of microbes increased 4.3-fold in the control group and 6.8-fold in Biofir-treated group. The probiotic kefir caused multiplication of the probiotic flora, meanwhile the undesired bacteria multiplied in the control group. No significant change of pH values of the faeces was found in both groups. The Hungarian probiotic kefir (Biofir) is capable of promoting multiplication of probiotic bacterial flora in the large bowel.

  13. Qualitative analysis of patient-centered decision attributes associated with initiating hepatitis C treatment.

    PubMed

    Zuchowski, Jessica L; Hamilton, Alison B; Pyne, Jeffrey M; Clark, Jack A; Naik, Aanand D; Smith, Donna L; Kanwal, Fasiha

    2015-10-01

    In this era of a constantly changing landscape of antiviral treatment options for chronic viral hepatitis C (CHC), shared clinical decision-making addresses the need to engage patients in complex treatment decisions. However, little is known about the decision attributes that CHC patients consider when making treatment decisions. We identify key patient-centered decision attributes, and explore relationships among these attributes, to help inform the development of a future CHC shared decision-making aid. Semi-structured qualitative interviews with CHC patients at four Veterans Health Administration (VHA) hospitals, in three comparison groups: contemplating CHC treatment at the time of data collection (Group 1), recently declined CHC treatment (Group 2), or recently started CHC treatment (Group 3). Participant descriptions of decision attributes were analyzed for the entire sample as well as by patient group and by gender. Twenty-nine Veteran patients participated (21 males, eight females): 12 were contemplating treatment, nine had recently declined treatment, and eight had recently started treatment. Patients on average described eight (range 5-13) decision attributes. The attributes most frequently reported overall were: physical side effects (83%); treatment efficacy (79%), new treatment drugs in development (55%); psychological side effects (55%); and condition of the liver (52%), with some variation based on group and gender. Personal life circumstance attributes (such as availability of family support and the burden of financial responsibilities) influencing treatment decisions were also noted by all participants. Multiple decision attributes were interrelated in highly complex ways. Participants considered numerous attributes in their CHC treatment decisions. A better understanding of these attributes that influence patient decision-making is crucial in order to inform patient-centered clinical approaches to care (such as shared decision-making augmented with relevant decision-making aids) that respond to patients' needs, preferences, and circumstances.

  14. Repeated doses of cardiac mesenchymal cells are therapeutically superior to a single dose in mice with old myocardial infarction.

    PubMed

    Guo, Yiru; Wysoczynski, Marcin; Nong, Yibing; Tomlin, Alex; Zhu, Xiaoping; Gumpert, Anna M; Nasr, Marjan; Muthusamy, Senthikumar; Li, Hong; Book, Michael; Khan, Abdur; Hong, Kyung U; Li, Qianhong; Bolli, Roberto

    2017-03-01

    We have recently demonstrated that repeated administrations of c-kit POS cardiac progenitor cells (CPCs) have cumulative beneficial effects in rats with old myocardial infarction (MI), resulting in markedly greater improvement in left ventricular (LV) function compared with a single administration. To determine whether this paradigm applies to other species and cell types, mice with a 3-week-old MI received one or three doses of cardiac mesenchymal cells (CMCs), a novel cell type that we have recently described. CMCs or vehicle were infused percutaneously into the LV cavity, 14 days apart. Compared with vehicle-treated mice, the single-dose group exhibited improved LV ejection fraction (EF) after the 1st infusion (consisting of CMCs) but not after the 2nd and 3rd (vehicle). In contrast, in the multiple-dose group, LV EF improved after each CMC infusion, so that at the end of the study, LV EF averaged 35.5 ± 0.7% vs. 32.7 ± 0.6% in the single-dose group (P < 0.05). The multiple-dose group also exhibited less collagen in the non-infarcted region vs. the single-dose group. Engraftment and differentiation of CMCs were negligible in both groups, indicating paracrine effects. These results demonstrate that, in mice with ischemic cardiomyopathy, the beneficial effects of three doses of CMCs are significantly greater than those of one dose, supporting the concept that multiple treatments are necessary to properly evaluate the full therapeutic potential of cell therapy. Thus, the repeated-treatment paradigm is not limited to c-kit POS CPCs or to rats, but applies to other cell types and species. The generalizability of this concept dramatically augments its significance.

  15. The IPSO study: ibuprofen, paracetamol study in osteoarthritis. A randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip

    PubMed Central

    Boureau, F; Schneid, H; Zeghari, N; Wall, R; Bourgeois, P

    2004-01-01

    Objective: To compare the analgesic efficacy of single and multiple doses of ibuprofen with that of paracetamol in patients with knee or hip osteoarthritis (IPSO study). Method: 222 patients were randomised in a double blind, multicentre study—156 (70%) had a painful knee joint and 66 (30%) a painful hip joint. The main efficacy criterion was pain intensity assessment after a single dose (ibuprofen 400 mg, paracetamol 1000 mg). Functional disability assessment and patient global assessment were carried out over 14 days. Results: The sum of the pain intensity difference over 6 hours after the first administration was significantly higher (p = 0.046) in the ibuprofen group than in the paracetamol group. Over 14 days pain intensity decreased from the first day and was significantly lower in the ibuprofen group than in the paracetamol group (p<0.05). The functional disability of the patient was assessed using the WOMAC; the ibuprofen group improved significantly over 2 weeks compared with the paracetamol group for each of the subscales: stiffness (p<0.002), pain (p<0.001), physical function (p<0.002). The drugs were equally safe. Conclusion: The IPSO study shows that for the treatment of osteoarthritic pain, ibuprofen 400 mg at a single and multiple dose (1200 mg/day) for 14 days is more effective than paracetamol, either as a single dose of 1000 mg or a multiple dose (3000 mg/day). Because ibuprofen and paracetamol have similar tolerability, this study indicates that the efficacy/tolerability ratio of ibuprofen is better than that of paracetamol in this indication over 14 days. PMID:15308513

  16. Physiotherapy Research Priorities in Switzerland: Views of the Various Stakeholders.

    PubMed

    Nast, Irina; Tal, Amir; Schmid, Stefan; Schoeb, Veronika; Rau, Barbara; Barbero, Marco; Kool, Jan

    2016-09-01

    Research priorities, defined by multiple stakeholders, can proximally facilitate the coordination of research projects and national and international cooperation and distally further improve the quality of physiotherapy practice. The aim of this study was therefore to establish physiotherapy research priorities in Switzerland considering multiple stakeholders' opinions. A mixed methods design was chosen. For a qualitative identification of physiotherapy research topics, 18 focus group discussions and 23 semi-structured interviews/written commentaries were conducted. For the quantitative analysis, 420 participants prioritized research topics using a two-round Delphi questionnaire survey. The following stakeholder groups were surveyed in the German-speaking, French-speaking and Italian-speaking regions of Switzerland: physiotherapy researchers, practitioners and educators, representatives of patient organizations, public health organizations, health insurers, physicians, nurses, occupational therapists and other health professionals, as well as physical educators. The top five overall physiotherapy research priorities identified were as follows: physiotherapy treatment, physiotherapy assessment and diagnosis, prevention, physiotherapist-patient interaction and physiotherapy professional education at the bachelor level. With regard to diagnostic groups, the highest priorities were placed on musculoskeletal disorders, neurology, orthopaedics, geriatrics and ergonomics/occupational health. Consensus was moderate to high, and only few differences between stakeholder groups were revealed. Research directly related to physiotherapy treatment is of highest priority. It should focus on diagnostic groups related to chronicity in anticipation of demographic changes. Multidisciplinary networks for research and practice, alongside sound coordination of research projects, should increase the impact of physiotherapy research. An accurate dissemination of research priorities, defined and supported by multiple stakeholder groups, might strengthen their impact on research and practice. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  17. A single blind randomized control trial on support groups for Chinese persons with mild dementia.

    PubMed

    Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

    2014-01-01

    Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

  18. Ethics of placebo-controlled clinical trials in multiple sclerosis: a reassessment.

    PubMed

    Polman, C H; Reingold, S C; Barkhof, F; Calabresi, P A; Clanet, M; Cohen, J A; Cutter, G R; Freedman, M S; Kappos, L; Lublin, F D; McFarland, H F; Metz, L M; Miller, A E; Montalban, X; O'Connor, P W; Panitch, H; Richert, J R; Petkau, J; Schwid, S R; Sormani, M P; Thompson, A J; Weinshenker, B G; Wolinsky, J S

    2008-03-25

    The increasing number of established effective therapies for relapsing multiple sclerosis (MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes.

  19. Teriflunomide: a once-daily oral medication for the treatment of relapsing forms of multiple sclerosis.

    PubMed

    Miller, Aaron E

    2015-10-01

    The purpose was to summarize US prescribing information for teriflunomide in the treatment of patients with relapsing forms of multiple sclerosis (RMS), with reference to clinical efficacy and safety outcomes. In September 2012, the US Food and Drug Administration granted approval for the use of teriflunomide, 14 mg and 7 mg once daily, to treat RMS on the basis of the results of a Phase II study and the Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) trial. After recent updates to the prescribing information (October 2014), key findings from these and 2 other Phase III clinical trials, TOWER (Teriflunomide Oral in People With Relapsing Multiple Sclerosis) and TOPIC (Oral Teriflunomide for Patients with a First Clinical Episode Suggestive of Multiple Sclerosis), and practical considerations for physicians are summarized. Teriflunomide, 14 mg and 7 mg, significantly reduced mean number of unique active lesions on magnetic resonance imaging (MRI; P < 0.05 for both doses) in the Phase II study. In the TEMSO and TOWER studies, the 14-mg dose of teriflunomide significantly reduced annualized relapse rate (31% and 36% relative risk reduction compared with placebo, respectively; both P < 0.001) and risk of disability progression sustained for 12 weeks (hazard ratio vs placebo 0.70 and 0.69, respectively; both P < 0.05). The 7-mg dose significantly (P < 0.02) reduced annualized relapse rate in both studies, although the reduction in risk of disability progression was not statistically significant. Teriflunomide treatment was also associated with significant efficacy on MRI measures of disease activity in TEMSO; both doses significantly reduced total lesion volume and number of gadolinium-enhancing T1 lesions. TOPIC evaluated patients with a first clinical event consistent with acute demyelination and brain MRI lesions characteristic of multiple sclerosis. More patients were free of relapse in the teriflunomide 14-mg and 7-mg groups than in the placebo group (P < 0.05 for both comparisons). In safety data pooled from the 4 studies, adverse events occurring in ≥2% of patients and ≥2% higher than in the placebo group were headache, alanine aminotransferase increase, diarrhea, alopecia (hair thinning), nausea, paresthesia, arthralgia, neutropenia, and hypertension. Routine monitoring procedures before and on treatment are recommended to assess potential safety issues. Women of childbearing potential must use effective contraception and, in the event of pregnancy, undergo an accelerated elimination procedure to reduce plasma concentrations of teriflunomide. Clinical evidence suggests that teriflunomide is an effective therapeutic choice for patients with RMS, both as an initial treatment and as an alternative for patients who may have experienced intolerance or inadequate response to a previous or current disease-modifying therapy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Chronic bacterial prostatitis and irritable bowel syndrome: effectiveness of treatment with rifaximin followed by the probiotic VSL#3.

    PubMed

    Vicari, Enzo; La Vignera, Sandro; Castiglione, Roberto; Condorelli, Rosita A; Vicari, Lucia O; Calogero, Aldo E

    2014-01-01

    This study was undertaken to evaluate the influence of treatment with rifaximin followed by the probiotic VSL#3 versus no treatment on the progression of chronic prostatitis toward chronic microbial prostate-vesiculitis (PV) or prostate-vesiculo-epididymitis (PVE). A total of 106 selected infertile male patients with bacteriologically cured chronic bacterial prostatitis (CBP) and irritable bowel syndrome (IBS) were randomly prescribed rifaximin (200 mg, 2 tablets bid, for 7 days monthly for 12 months) and probiotic containing multiple strains VSL#3 (450 × 10(9) FU per day) or no treatment. Ninety-five of them (89.6%) complied with the therapeutic plan and were included in this study. Group A = "6Tx/6-": treatment for the initial 6 and no treatment for the following 6 months (n = 26); Group B = "12Tx": 12 months of treatment (n = 22); Group C = "6-/6Tx": no treatment for the initial 6 months and treatment in the last 6 months (n = 23); Group D = "12-": no treatment (n = 24). The patients of Groups A = "6Tx/6-" and B = "12Tx" had the highest frequency of chronic prostatitis (88.5% and 86.4%, respectively). In contrast, group "12-": patients had the lowest frequency of prostatitis (33.4%). The progression of prostatitis into PV in groups "6Tx/6-" (15.5%) and "6-/6Tx" (13.6%) was lower than that found in the patients of group "12-" (45.8%). Finally, no patient of groups "6Tx/6-" and "6-/6Tx" had PVE, whereas it was diagnosed in 20.8% of group "12-" patients. Long-term treatment with rifaximin and the probiotic VSL#3 is effective in lowering the progression of prostatitis into more complicated forms of male accessory gland infections in infertile patients with bacteriologically cured CBP plus IBS.

  1. Chronic bacterial prostatitis and irritable bowel syndrome: effectiveness of treatment with rifaximin followed by the probiotic VSL#3

    PubMed Central

    Vicari, Enzo; Vignera, La Sandro; Castiglione, Roberto; Condorelli, Rosita A; Vicari, Lucia O; Calogero, Aldo E

    2014-01-01

    This study was undertaken to evaluate the influence of treatment with rifaximin followed by the probiotic VSL#3 versus no treatment on the progression of chronic prostatitis toward chronic microbial prostate-vesiculitis (PV) or prostate-vesiculo-epididymitis (PVE). A total of 106 selected infertile male patients with bacteriologically cured chronic bacterial prostatitis (CBP) and irritable bowel syndrome (IBS) were randomly prescribed rifaximin (200 mg, 2 tablets bid, for 7 days monthly for 12 months) and probiotic containing multiple strains VSL#3 (450 × 109 CFU per day) or no treatment. Ninety-five of them (89.6%) complied with the therapeutic plan and were included in this study. Group A = “6Tx/6-”: treatment for the initial 6 and no treatment for the following 6 months (n = 26); Group B = “12Tx”: 12 months of treatment (n = 22); Group C = “6-/6Tx”: no treatment for the initial 6 months and treatment in the last 6 months (n = 23); Group D = “12-”: no treatment (n = 24). The patients of Groups A = “6Tx/6-” and B = “12Tx” had the highest frequency of chronic prostatitis (88.5% and 86.4%, respectively). In contrast, group “12-”: patients had the lowest frequency of prostatitis (33.4%). The progression of prostatitis into PV in groups “6Tx/6-” (15.5%) and “6-/6Tx” (13.6%) was lower than that found in the patients of group “12-” (45.8%). Finally, no patient of groups “6Tx/6-” and “6-/6Tx” had PVE, whereas it was diagnosed in 20.8% of group “12-” patients. Long-term treatment with rifaximin and the probiotic VSL#3 is effective in lowering the progression of prostatitis into more complicated forms of male accessory gland infections in infertile patients with bacteriologically cured CBP plus IBS. PMID:24969056

  2. Frequent intravenous pulses of growth hormone together with alanylglutamine supplementation in prolonged critical illness after multiple trauma: effects on glucose control, plasma IGF-I and glutamine.

    PubMed

    Duska, Frantisek; Fric, Michal; Pazout, Jaroslav; Waldauf, Petr; Tůma, Petr; Pachl, Jan

    2008-02-01

    We aim to demonstrate that low dose growth hormone (GH) administered in i.v. pulses every 3h is able to normalize IGF-I levels in subjects with prolonged critical illness, after multiple trauma. We also ask whether it is possible to control glycaemia during such a treatment and how alanylglutamine (AG) supplementation influences plasma glutamine concentration. We used a prospective double-blind (group 1 vs. 2), randomized trial with an open-label control arm (group 3). Thirty multiple trauma patients (median age: 36, 42, 46 years) were randomized on day 4 after trauma to receive (group 1, n=10) i.v. AG supplementation (0.3 g/kg day from day 4 till 17) and i.v. GH (0.05 mg/kg day divided into 8 boluses, maximum dose at 3 AM, administered on days 7-17) or AG and placebo (group 2, n=10). Group 3 (n=10) received isocaloric isonitrogenous (proteins 1.5 g/kg day) nutrition without AG. Glycaemia was controlled by i.v. insulin infusion according to a routine protocol. GH treatment caused an increase of IGF-I (from median 169 on day 4 to 493 ng/ml on day 17), IGFBP-3 (from 2.4 to 3.2 microg/ml) and a fall in IGFBP-1 (from 11.5 to 3.1 microg/ml), whilst in both groups 2 and 3 these indices remained unchanged. At the end of the study (day 17) IGF-I and IGFBP-1 differed significantly among groups (p=0.008 resp. p=0.010, Kruskal-Wallis). Plasma glutamine remained below the normal range through the study in all groups (median: 0.18-0.30 mM), but had a tendency to rise in group 2 in contrast with a fall in groups 1 and 3 (NS). Group 1 required more insulin (p<0.01) than did the control group but median glycaemia was only 0.4-0.5 mM higher in group 1 (6.5 mM) than in groups 2 and 3 (6.1 resp. 6.0 mM). GH (0.05 g/kg day) administered in i.v. pulses is able to normalize IGF-I levels in subjects with prolonged critical illness after trauma. During this treatment, the standard dose of AG prevents worsening of plasma glutamine deficiency and glucose control is possible using routine algorithms, but it requires higher insulin doses.

  3. Development of Biomarkers for Screening Hepatocellular Carcinoma Using Global Data Mining and Multiple Reaction Monitoring

    PubMed Central

    Yu, Su Jong; Jang, Eun Sun; Yu, Jiyoung; Cho, Geunhee; Yoon, Jung-Hwan; Kim, Youngsoo

    2013-01-01

    Hepatocellular carcinoma (HCC) is one of the most common and aggressive cancers and is associated with a poor survival rate. Clinically, the level of alpha-fetoprotein (AFP) has been used as a biomarker for the diagnosis of HCC. The discovery of useful biomarkers for HCC, focused solely on the proteome, has been difficult; thus, wide-ranging global data mining of genomic and proteomic databases from previous reports would be valuable in screening biomarker candidates. Further, multiple reaction monitoring (MRM), based on triple quadrupole mass spectrometry, has been effective with regard to high-throughput verification, complementing antibody-based verification pipelines. In this study, global data mining was performed using 5 types of HCC data to screen for candidate biomarker proteins: cDNA microarray, copy number variation, somatic mutation, epigenetic, and quantitative proteomics data. Next, we applied MRM to verify HCC candidate biomarkers in individual serum samples from 3 groups: a healthy control group, patients who have been diagnosed with HCC (Before HCC treatment group), and HCC patients who underwent locoregional therapy (After HCC treatment group). After determining the relative quantities of the candidate proteins by MRM, we compared their expression levels between the 3 groups, identifying 4 potential biomarkers: the actin-binding protein anillin (ANLN), filamin-B (FLNB), complementary C4-A (C4A), and AFP. The combination of 2 markers (ANLN, FLNB) improved the discrimination of the before HCC treatment group from the healthy control group compared with AFP. We conclude that the combination of global data mining and MRM verification enhances the screening and verification of potential HCC biomarkers. This efficacious integrative strategy is applicable to the development of markers for cancer and other diseases. PMID:23717429

  4. Development of biomarkers for screening hepatocellular carcinoma using global data mining and multiple reaction monitoring.

    PubMed

    Kim, Hyunsoo; Kim, Kyunggon; Yu, Su Jong; Jang, Eun Sun; Yu, Jiyoung; Cho, Geunhee; Yoon, Jung-Hwan; Kim, Youngsoo

    2013-01-01

    Hepatocellular carcinoma (HCC) is one of the most common and aggressive cancers and is associated with a poor survival rate. Clinically, the level of alpha-fetoprotein (AFP) has been used as a biomarker for the diagnosis of HCC. The discovery of useful biomarkers for HCC, focused solely on the proteome, has been difficult; thus, wide-ranging global data mining of genomic and proteomic databases from previous reports would be valuable in screening biomarker candidates. Further, multiple reaction monitoring (MRM), based on triple quadrupole mass spectrometry, has been effective with regard to high-throughput verification, complementing antibody-based verification pipelines. In this study, global data mining was performed using 5 types of HCC data to screen for candidate biomarker proteins: cDNA microarray, copy number variation, somatic mutation, epigenetic, and quantitative proteomics data. Next, we applied MRM to verify HCC candidate biomarkers in individual serum samples from 3 groups: a healthy control group, patients who have been diagnosed with HCC (Before HCC treatment group), and HCC patients who underwent locoregional therapy (After HCC treatment group). After determining the relative quantities of the candidate proteins by MRM, we compared their expression levels between the 3 groups, identifying 4 potential biomarkers: the actin-binding protein anillin (ANLN), filamin-B (FLNB), complementary C4-A (C4A), and AFP. The combination of 2 markers (ANLN, FLNB) improved the discrimination of the before HCC treatment group from the healthy control group compared with AFP. We conclude that the combination of global data mining and MRM verification enhances the screening and verification of potential HCC biomarkers. This efficacious integrative strategy is applicable to the development of markers for cancer and other diseases.

  5. Two Years Follow up of Domain Specific Cognitive Training in Relapsing Remitting Multiple Sclerosis: A Randomized Clinical Trial

    PubMed Central

    Mattioli, Flavia; Bellomi, Fabio; Stampatori, Chiara; Provinciali, Leandro; Compagnucci, Laura; Uccelli, Antonio; Pardini, Matteo; Santuccio, Giuseppe; Fregonese, Giuditta; Pattini, Marianna; Allegri, Beatrice; Clerici, Raffaella; Lattuada, Annalisa; Montomoli, Cristina; Corso, Barbara; Gallo, Paolo; Riccardi, Alice; Ghezzi, Angelo; Roscio, Marco; Tola, Maria Rosaria; Calanca, Chiara; Baldini, Daria; Trafficante, Debora; Capra, Ruggero

    2016-01-01

    Cognitive rehabilitation in multiple sclerosis (MS) has been reported to induce neuropsychological improvements, but the persistence of these effects has been scarcely investigated over long follow ups. Here, the results of a multicenter randomized clinical trial are reported, in which the efficacy of 15 week domain specific cognitive training was evaluated at 2 years follow up in 41 patients. Included patients were randomly assigned either to domain specific cognitive rehabilitation, or to aspecific psychological intervention. Patients who still resulted to be cognitively impaired at 1 year follow up were resubmitted to the same treatment, whereas the recovered ones were not. Neuropsychological tests and functional scales were administered at 2 years follow up to all the patients. Results revealed that both at 1 and at 2 years follow up more patients in the aspecific group (18/19, 94% and 13/17, 76% respectively) than in the specific group (11/22, 50% and 5/15, 33% respectively) resulted to be cognitively impaired. Furthermore patients belonging to the specific group showed significantly less impaired tests compared with the aspecific group ones (p = 0.02) and a significant amelioration in the majority of the tests. On the contrary patients in the aspecific group did not change. The specific group subjects also perceived a subjective improvement in their cognitive performance, while the aspecific group patients did not. These results showed that short time domain specific cognitive rehabilitation is a useful treatment for patients with MS, shows very long lasting effects, compared to aspecific psychological interventions. Also subjective cognitive amelioration was found in patients submitted to domain specific treatment after 2 years. PMID:26941630

  6. International Myeloma Working Group recommendations for global myeloma care.

    PubMed

    Ludwig, H; Miguel, J S; Dimopoulos, M A; Palumbo, A; Garcia Sanz, R; Powles, R; Lentzsch, S; Ming Chen, W; Hou, J; Jurczyszyn, A; Romeril, K; Hajek, R; Terpos, E; Shimizu, K; Joshua, D; Hungria, V; Rodriguez Morales, A; Ben-Yehuda, D; Sondergeld, P; Zamagni, E; Durie, B

    2014-05-01

    Recent developments have led to remarkable improvements in the assessment and treatment of patients with multiple myeloma (MM). New technologies have become available to precisely evaluate the biology and extent of the disease, including information about cytogenetics and genetic abnormalities, extramedullary manifestations and minimal residual disease. New, more effective drugs have been introduced into clinical practice, which enable clinicians to significantly improve the outcome of patients but also pose new challenges for the prevention and management of their specific side effects. Given these various new options and challenges, it is important to identify the minimal requirements for diagnosis and treatment of patients, as access to the most sophisticated advances may vary depending on local circumstances. Here, we propose the minimal requirements and possible options for diagnosis, monitoring and treatment of patients with multiple myeloma.

  7. MEASURING EVERYDAY RACIAL/ETHNIC DISCRIMINATION IN HEALTH SURVEYS: How Best to Ask the Questions, in One or Two Stages, Across Multiple Racial/Ethnic Groups?

    PubMed

    Shariff-Marco, Salma; Breen, Nancy; Landrine, Hope; Reeve, Bryce B; Krieger, Nancy; Gee, Gilbert C; Williams, David R; Mays, Vickie M; Ponce, Ninez A; Alegría, Margarita; Liu, Benmei; Willis, Gordon; Johnson, Timothy P

    2011-01-01

    While it is clear that self-reported racial/ethnic discrimination is related to illness, there are challenges in measuring self-reported discrimination or unfair treatment. In the present study, we evaluate the psychometric properties of a self-reported instrument across racial/ ethnic groups in a population-based sample, and we test and interpret findings from applying two different widely-used approaches to asking about discrimination and unfair treatment. Even though we found that the subset of items we tested tap into a single underlying concept, we also found that different groups are more likely to report on different aspects of discrimination. Whether race is mentioned in the survey question affects both frequency and mean scores of reports of racial/ethnic discrimination. Our findings suggest caution to researchers when comparing studies that have used different approaches to measure racial/ethnic discrimination and allow us to suggest practical empirical guidelines for measuring and analyzing racial/ethnic discrimination. No less important, we have developed a self-reported measure of recent racial/ethnic discrimination that functions well in a range of different racial/ethnic groups and makes it possible to compare how racial/ethnic discrimination is associated with health disparities among multiple racial/ethnic groups.

  8. [Infiltration of tumor associated macrophages in multiple myeloma and its clinical significance].

    PubMed

    Gui, Q L; Wang, Y S; Huang, S; Wan, Y; Wang, H P; Zhu, Z G; Li, M M; Zhu, H Y; Tao, Q S; Shen, Y Y; Zhang, Q; Qin, H

    2018-02-14

    Objective: To investigate the clinical significance of tumor associated macrophages (TAM) in multiple myeloma (MM) and the relationship with angiogenesis and immunosuppression. Methods: Seventy cases of MM patients diagnosed from August 2015 to June 2017 were enrolled in the study as experimental group, 20 cases of benign hematological diseases (13 with iron deficiency anemia and 7 with megaloblastic anemia) patients as control group. Immunohistochemical method was used to detect the expression of CD163, CD34 and VEGF in bone marrow samples, and flow cytometry was used to detect the proportion of regulatory T cell (Treg cells), ELISA was used to detect the level of IL-10, and the clinical features were analyzed. Results: ①Among the 70 patients, there were 31 males and 39 females with a median age of 65 (50~78) years old. TAM infiltration density, microvascular density (MVD), VEGF expression level, Treg ratio and IL-10 level in bone marrow samples of 70 MM patients were significantly higher than those of benign hematological diseases ( P <0.05). ②In the MM group, the above indexes of the patients with disease stabilized (15 cases) were lower than those of the newly diagnosed group (35 cases) and the relapse refractory group (20 cases) ( P <0.05), those of relapse refractory group were higher than those of newly diagnosed group ( P >0.05). ③Of the 35 newly diagnosed MM patients, 27 completed 4 courses of treatment. In the effective group (15 cases), the TAM infiltration density after treatment was significantly lower than that before treatment, the difference was statistically significant[(20.20±7.66) vs (28.87±11.97), t =2.362, P =0.025]; while in the ineffective group of 12 cases, the difference of the TAM infiltration density before and after treatment was not statistically significant[(42.00±13.76) vs (48.25±13.59), t =1.119, P =0.275]. ④TAM infiltration density in the effective group after bortezomib treatment (21 cases) were lower than those in the non-bortezomib treatment group (18 cases)[(16.52 ±4.26) vs (19.27 ±5.82), t =1.662, P =0.170]. ⑤The TAM infiltration density in MM patients was positively correlated with MVD, VEGF expression level, Treg cell ratio and IL-10 level ( P <0.001). Conclusion: The infiltration of TAM in the microenvironment of MM, which may promoting angiogenesis and inhibiting immune response, is related to the occurrence, development, therapeutic effect and drug resistance of MM.

  9. The effects of computer simulation versus hands-on dissection and the placement of computer simulation within the learning cycle on student achievement and attitude

    NASA Astrophysics Data System (ADS)

    Hopkins, Kathryn Susan

    The value of dissection as an instructional strategy has been debated, but not evidenced in research literature. The purpose of this study was to examine the efficacy of using computer simulated frog dissection as a substitute for traditional hands-on frog dissection and to examine the possible enhancement of achievement by combining the two strategies in a specific sequence. In this study, 134 biology students at two Central Texas schools were divided into the five following treatment groups: computer simulation of frog dissection, computer simulation before dissection, traditional hands-on frog dissection, dissection before computer simulation, and textual worksheet materials. The effects on achievement were evaluated by labeling 10 structures on three diagrams, identifying 11 pinned structures on a prosected frog, and answering 9 multiple-choice questions over the dissection process. Attitude was evaluated using a thirty item survey with a five-point Likert scale. The quasi-experimental design was pretest/post-test/post-test nonequivalent group for both control and experimental groups, a 2 x 2 x 5 completely randomized factorial design (gender, school, five treatments). The pretest/post-test design was incorporated to control for prior knowledge using analysis of covariance. The dissection only group evidenced a significantly higher performance than all other treatments except dissection-then-computer on the post-test segment requiring students to label pinned anatomical parts on a prosected frog. Interactions between treatment and school in addition to interaction between treatment and gender were found to be significant. The diagram and attitude post-tests evidenced no significant difference. Results on the nine multiple-choice questions about dissection procedures indicated a significant difference between schools. The interaction between treatment and school was also found to be significant. On a delayed post-test, a significant difference in gender was found on the diagram labeling segment of the post-test. Males were reported to have the higher score. Since existing research conflicts with this study's results, additional research using authentic assessment is recommended. Instruction should be aligned with dissection content and process objectives for each treatment group, and the teacher variable should be controlled.

  10. Recommendations for the detection and therapeutic management of cognitive impairment in multiple sclerosis.

    PubMed

    Bensa, C; Bodiguel, E; Brassat, D; Laplaud, D; Magy, L; Ouallet, J-C; Zephir, H; De Seze, J; Blanc, F

    2012-11-01

    The aim of the Multiple Sclerosis Think Tank (Groupe de réflexion sur la sclérose en plaques [GRESEP]) is to prescribe recommendations following a systematic literature search and using a Rand Corporation and California University (RAND/UCLA) appropriateness derived method, in response to practical questions that are raised in the management of patients with multiple sclerosis (MS). The topics of this working program were chosen because they were not addressed in the French recommendations and because of the few data in the literature that enabled practices to be based on validated data. Following the theme on useful serum testing with suspected multiple sclerosis, the subjects of the present work concern the detection and management of cognitive impairment in the beginning stages of the disease course. Two clinical questions were asked: which complementary exams (besides physical examination and neuropsychological tests) would help in the screening of cognitive impairment at the beginning of the disease? What care management should the person with MS and cognitive impairment be offered (treatments and neurocognitive rehabilitation)? The recommendations are the result of a consensus amongst a working group, a rating group and a reading group comprised of hospital neurologists involved in the management of patients with multiple sclerosis. Each recommendation is presented with the degree of consensus that it was accorded. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  11. Survey of Latin American Neuroimmunologists on the Treatment of Multiple Sclerosis with Monoclonal Antibodies.

    PubMed

    Fragoso, Yara Dadalti

    2015-01-01

    Natalizumab and alemtuzumab are monoclonal antibodies approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). A third monoclonal antibody, daclizumab, should soon become another alternative for RRMS therapy. A group of 26 doctors working at specific MS Units in seven different Latin American countries participated in the present study. All 26 neurologists had experience with natalizumab for the treatment of MS and were willing to discuss strategies for improving this treatment. Most neurologists had no confidence in starting a patient on natalizumab and alemtuzumab, which are new and efficient drugs approved by North American, European and most Latin American health agencies. The Latin American specialists felt they were not properly informed on daclizumab. Specific pharmacovigilance programs for each of these monoclonal antibodies were considered very important by the neurologists, who were also willing to discuss these therapeutic options with peers from other countries.

  12. [Living in hemodialysis without social insurance: The voices of renal sick people and their families].

    PubMed

    Mercado-Martínez, Francisco J; Correa-Mauricio, Mauricio E

    2015-01-01

    To examine the perspectives and practices of renal sick people and their families without social insurance regarding problems faced while on dialysis treatment. A qualitative research was developed in Guadalajara, Mexico. Thirty-seven renal sick people on hemodialysis and 50 relatives participated; all affiliated to Seguro Popular. Information was gathered through individual and group interviews. Directed content analysis was carried out. Renal sick people and their families face multiple difficulties while on hemodialysis treatment; nevertheless, economic ones are perceived as a priority due to treatment expenses, lack of financial resources and non-coverage of kidney disease by Seguro Popular. Multiple actions are combined in a circular searching for help process to face the economic burden. Hemodialysis treatment is an unbearable economic burden for renal sick people and their families without social insurance. Universal access to renal therapies should be implemented urgently.

  13. Developing an integrated treatment for substance use and depression using cognitive-behavioral therapy.

    PubMed

    Osilla, Karen Chan; Hepner, Kimberly A; Muñoz, Ricardo F; Woo, Stephanie; Watkins, Katherine

    2009-12-01

    Providing a unified treatment approach to meet the substance abuse and mental health needs of clients is the preferred model for addressing co-occurring disorders. We developed a group-based cognitive-behavioral (CBT) integrated treatment for depression and substance use disorders (SUD) that could be delivered by counselors in SUD treatment settings and evaluated its feasibility and acceptability. We conducted an in-depth case study examining one implementation of the treatment using 15 focus groups with clients (n = 7) and semistructured interviews with counselors (n = 2) and administrators (n = 3). Using CBT as a treatment approach to integrate the treatment was widely accepted by clients, counselors, and administrators. Clients stated the treatment was applicable to multiple aspects of their lives and allowed them to recognize their clinical improvements over time. Counselors and administrators discussed challenges for long-term feasibility. Key decisions used to develop the treatment and recommendations for implementing integrated care in SUD settings are discussed.

  14. Evaluation of the role of 8-iso-PGF levels at multiple sites during intracranial hemorrhage in pediatric patients.

    PubMed

    Qi, B-X; Yao, H; Shang, L; Sheng, L-P; Wang, X-C; Zhu, L; Zhang, X-X; Wang, J-P; Fang, D-H

    2017-09-01

    The present study was planned to explore the role of 8-isomeric-prostaglandinF2α (8-iso-PGF2α) levels at the multiple sites of cerebrospinal fluid in children with intracranial hemorrhage. 90 children with intracranial hemorrhage were admitted to Surgery Intensive Care Unit (SICU) of our hospital from January to December 2013 and were selected as study subjects. They were divided into group A (n=30), group B (n=30) and group C (n=30). The group A was given conventional treatment, the group B was treated with minimally invasive puncture and the group C was treated with cerebrospinal fluid decompression. After 1 d, 2 d, 3 d, and 7 d of hospitalization, enzyme-linked immunosorbent assay (ELISA) was used to detect the 8-iso-PGF2α levels in peripheral blood of children in all groups. On the day of admission and 10 d after treatment, 3 groups of children were implemented with brain nuclear magnetic resonance spectroscopy for metabolite analyses. On the day of admission there were no significant differences in the 8-iso-PGF2α levels among group A, B and C. Further, after 1 d, 3 d, 7 d of hospital stay, the 8-iso-PGF2α levels in peripheral blood showed a gradual downward trend, and decline range of the group C was greater than that of group A and B (p < 0.05). After 10 days of treatment, there were significant differences in the bilateral temporal lobe and hippocampal NAA/Creatinine (Cr), Cho/Cr, mI/Cr and NAA/mI among group A, B, and C. The survival rate of group C was higher than that of group A and B (p < 0.05). On the other hand, the prevalence of sequelae was significantly lower than that of group A and B (p < 0.05). The amount of blood loss in children with intracranial hemorrhage was positively correlated with the levels of 8-iso-PGF2α in peripheral blood (r = 0.546, p < 0.05) as observed by Spearman correlation analysis. 8-iso-PGF2α plays an important role in the pathogenesis of intracranial hemorrhage, and could be utilized as a biomarker of oxidative stress in children with intracranial hemorrhage. Further, cerebrospinal fluid decompression is a better method of treatment for intracranial hemorrhage.

  15. Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial.

    PubMed

    Duggleby, Wendy; Ploeg, Jenny; McAiney, Carrie; Peacock, Shelley; Fisher, Kathryn; Ghosh, Sunita; Markle-Reid, Maureen; Swindle, Jennifer; Williams, Allison; Triscott, Jean Ac; Forbes, Dorothy; Jovel Ruiz, Kathya

    2018-06-29

    My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer's disease and related dementia and multiple chronic conditions through their transition experiences. The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer's disease and related dementia and multiple chronic conditions. A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h). ©Wendy Duggleby, Jenny Ploeg, Carrie McAiney, Shelley Peacock, Kathryn Fisher, Sunita Ghosh, Maureen Markle-Reid, Jennifer Swindle, Allison Williams, Jean AC Triscott, Dorothy Forbes, Kathya Jovel Ruiz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.06.2018.

  16. Palatability and oral cavity tolerability of THC:CBD oromucosal spray and possible improvement measures in multiple sclerosis patients with resistant spasticity: a pilot study.

    PubMed

    Lus, Giacomo; Cantello, Roberto; Danni, Maura Chiara; Rini, Agusto; Sarchielli, Paola; Tassinari, Tiziana; Signoriello, Elisabetta

    2018-04-01

    Complaints about Δ 9 -tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex ® ; GW Pharma Ltd, Salisbury, UK) in the management of multiple sclerosis spasticity include unpleasant taste and oral mucosal anomalies. This pilot study assessed the use of sugar-free chewing gum and/or a refrigerated bottle of THC:CBD oromucosal spray to mitigate these effects. Patients with multiple sclerosis spasticity (n = 52) at six sites in Italy who were receiving THC:CBD oromucosal spray and had associated oral mucosal effects were randomized into Group A (chewing gum; n = 15); Group B (cold bottle; n = 20); and Group C (cold bottle + chewing gum; n = 17). Taste perception in patients receiving chewing gum ± cold bottle intervention (Groups A and C combined) was significantly (p = 0.0001) improved from baseline to week 4 while maintaining spasticity control. Patient comfort, satisfaction and treatment adherence may benefit from these interventions.

  17. Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) is a registered, double-blinded, randomized, controlled trial designed to assess the efficacy of osteopathic manipulative treatment (OMT) as an adjunctive treatment in elderly patients with pneumonia. Methods 406 subjects aged ≥ 50 years hospitalized with pneumonia at 7 community hospitals were randomized using concealed allocation to conventional care only (CCO), light-touch treatment (LT), or OMT groups. All subjects received conventional treatment for pneumonia. OMT and LT groups received group-specific protocols for 15 minutes, twice daily until discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The primary outcomes were hospital length of stay (LOS), time to clinical stability, and a symptomatic and functional recovery score. Results Intention-to-treat (ITT) analysis (n = 387) found no significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant difference between groups (P = 0.01) in LOS. Multiple comparisons indicated a reduction in median LOS (95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5 [3.9-4.9] days), but not versus the LT group (3.9 [3.5-4.8] days). Secondary outcomes of duration of intravenous antibiotics and treatment endpoint were also significantly different between groups (P = 0.05 and 0.006, respectively). Duration of intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the CCO group, but not versus the LT group. Conclusions ITT analysis found no differences between groups. PP analysis found significant reductions in LOS, duration of intravenous antibiotics, and respiratory failure or death when OMT was compared to CCO. Given the prevalence of pneumonia, adjunctive OMT merits further study. PMID:20302619

  18. Neural Correlates of Alerting and Orienting Impairment in Multiple Sclerosis Patients

    PubMed Central

    Vázquez-Marrufo, Manuel; Galvao-Carmona, Alejandro; González-Rosa, Javier J.; Hidalgo-Muñoz, Antonio R.; Borges, Mónica; Ruiz-Peña, Juan Luis; Izquierdo, Guillermo

    2014-01-01

    Background A considerable percentage of multiple sclerosis patients have attentional impairment, but understanding its neurophysiological basis remains a challenge. The Attention Network Test allows 3 attentional networks to be studied. Previous behavioural studies using this test have shown that the alerting network is impaired in multiple sclerosis. The aim of this study was to identify neurophysiological indexes of the attention impairment in relapsing-remitting multiple sclerosis patients using this test. Results After general slowing had been removed in patients group to isolate the effects of each condition, some behavioral differences between them were obtained. About Contingent Negative Variation, a statistically significant decrement were found in the amplitude for Central and Spatial Cue Conditions for patient group (p<0.05). ANOVAs showed for the patient group a significant latency delay for P1 and N1 components (p<0.05) and a decrease of P3 amplitude for congruent and incongruent stimuli (p<0.01). With regard to correlation analysis, PASAT-3s and SDMT showed significant correlations with behavioral measures of the Attention Network Test (p<0.01) and an ERP parameter (CNV amplitude). Conclusions Behavioral data are highly correlated with the neuropsychological scores and show that the alerting and orienting mechanisms in the patient group were impaired. Reduced amplitude for the Contingent Negative Variation in the patient group suggests that this component could be a physiological marker related to the alerting and orienting impairment in relapsing-remitting multiple sclerosis. P1 and N1 delayed latencies are evidence of the demyelination process that causes impairment in the first steps of the visual sensory processing. Lastly, P3 amplitude shows a general decrease for the pathological group probably indexing a more central impairment. These results suggest that the Attention Network Test give evidence of multiple levels of attention impairment, which could help in the assessment and treatment of relapsing-remitting multiple sclerosis patients. PMID:24820333

  19. Neural correlates of alerting and orienting impairment in multiple sclerosis patients.

    PubMed

    Vázquez-Marrufo, Manuel; Galvao-Carmona, Alejandro; González-Rosa, Javier J; Hidalgo-Muñoz, Antonio R; Borges, Mónica; Ruiz-Peña, Juan Luis; Izquierdo, Guillermo

    2014-01-01

    A considerable percentage of multiple sclerosis patients have attentional impairment, but understanding its neurophysiological basis remains a challenge. The Attention Network Test allows 3 attentional networks to be studied. Previous behavioural studies using this test have shown that the alerting network is impaired in multiple sclerosis. The aim of this study was to identify neurophysiological indexes of the attention impairment in relapsing-remitting multiple sclerosis patients using this test. After general slowing had been removed in patients group to isolate the effects of each condition, some behavioral differences between them were obtained. About Contingent Negative Variation, a statistically significant decrement were found in the amplitude for Central and Spatial Cue Conditions for patient group (p<0.05). ANOVAs showed for the patient group a significant latency delay for P1 and N1 components (p<0.05) and a decrease of P3 amplitude for congruent and incongruent stimuli (p<0.01). With regard to correlation analysis, PASAT-3s and SDMT showed significant correlations with behavioral measures of the Attention Network Test (p<0.01) and an ERP parameter (CNV amplitude). Behavioral data are highly correlated with the neuropsychological scores and show that the alerting and orienting mechanisms in the patient group were impaired. Reduced amplitude for the Contingent Negative Variation in the patient group suggests that this component could be a physiological marker related to the alerting and orienting impairment in relapsing-remitting multiple sclerosis. P1 and N1 delayed latencies are evidence of the demyelination process that causes impairment in the first steps of the visual sensory processing. Lastly, P3 amplitude shows a general decrease for the pathological group probably indexing a more central impairment. These results suggest that the Attention Network Test give evidence of multiple levels of attention impairment, which could help in the assessment and treatment of relapsing-remitting multiple sclerosis patients.

  20. A controlled study of the effect of a mindfulness-based stress reduction technique in women with multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia

    PubMed Central

    Sampalli, Tara; Berlasso, Elizabeth; Fox, Roy; Petter, Mark

    2009-01-01

    Background: The objective of this study was to examine the effect of a mindfulness-based stress reduction (MBSR) program on women diagnosed with conditions such as multiple chemical sensitivity (MCS), chronic fatigue syndrome (CFS), and fibromyalgia (FM). Methods: The intervention group underwent a 10-week MBSR program. Symptoms Checklist Inventory (SCL-90R) was used as outcome measure and was administered before the start of the program (pre-), immediately upon completion (post-) and at three-month follow-up. Women on the wait list to receive treatment at the Nova Scotia Environmental Health Centre were used as control subjects for the study. Results: A total of 50 participants in the intervention group and 26 in the wait-list controls group were recruited for this study. Global scores in the intervention group reached statistical significance pre-post (<0.0001) and at pre-follow-up (<0.0001) while the global scores in the control group remained the same. Five of nine and eight of nine subscales of the SCL-90R showed improvement of statistical significance in MBSR group following treatment and at three-month follow-up. Conclusions: The study showed the importance of complementary interventions such as MBSR techniques in the reduction of psychological distress in women with chronic conditions. PMID:21197347

  1. Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial.

    PubMed

    Yang, Jin-Ji; Zhou, Caicun; Huang, Yisheng; Feng, Jifeng; Lu, Sun; Song, Yong; Huang, Cheng; Wu, Gang; Zhang, Li; Cheng, Ying; Hu, Chengping; Chen, Gongyan; Zhang, Li; Liu, Xiaoqing; Yan, Hong Hong; Tan, Fen Lai; Zhong, Wenzhao; Wu, Yi-Long

    2017-09-01

    For patients with non-small-cell lung cancer (NSCLC) and multiple brain metastases, whole-brain irradiation (WBI) is a standard-of-care treatment, but its effects on neurocognition are complex and concerning. We compared the efficacy of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), icotinib, versus WBI with or without chemotherapy in a phase 3 trial of patients with EGFR-mutant NSCLC and multiple brain metastases. We did a multicentre, open-label, parallel randomised controlled trial (BRAIN) at 17 hospitals in China. Eligible participants were patients with NSCLC with EGFR mutations, who were naive to treatment with EGFR-TKIs or radiotherapy, and had at least three metastatic brain lesions. We randomly assigned participants (1:1) to either icotinib 125 mg orally (three times per day) or WBI (30 Gy in ten fractions of 3 Gy) plus concurrent or sequential chemotherapy for 4-6 cycles, until unacceptable adverse events or intracranial disease progression occurred. The randomisation was done by the Chinese Thoracic Oncology Group with a web-based allocation system applying the Pocock and Simon minimisation method; groups were stratified by EGFR gene mutation status, treatment line (first line or second line), brain metastases only versus both intracranial and extracranial metastases, and presence or absence of symptoms of intracranial hypertension. Clinicians and patients were not masked to treatment assignment, but individuals involved in the data analysis did not participate in the treatments and were thus masked to allocation. Patients receiving icotinib who had intracranial progression only were switched to WBI plus either icotinib or chemotherapy until further progression; those receiving icotinib who had extracranial progression only were switched to icotinib plus chemotherapy. Patients receiving WBI who progressed were switched to icotinib until further progression. Icotinib could be continued beyond progression if a clinical benefit was observed by the investigators (eg, an improvement in cognition or intracranial pressure). The primary endpoint was intracranial progression-free survival (PFS), defined as the time from randomisation to either intracranial disease progression or death from any cause. We assessed efficacy and safety in the intention-to-treat population (all participants who received at least one dose of study treatment), hypothesising that intracranial PFS would be 40% longer (hazard ratio [HR] 0·60) with icotinib compared with WBI. This trial is registered with ClinicalTrials.gov, number NCT01724801. Between Dec 10, 2012, and June 30, 2015, we assigned 176 participants to treatment: 85 to icotinib and 91 to WBI. 18 withdrew from the WBI group before treatment, leaving 73 for assessment. Median follow-up was 16·5 months (IQR 11·5-21·5). Median intracranial PFS was 10·0 months (95% CI 5·6-14·4) with icotinib versus 4·8 months (2·4-7·2) with WBI (equating to a 44% risk reduction with icotinib for an event of intracranial disease progression or death; HR 0·56, 95% CI 0·36-0·90; p=0·014). Adverse events of grade 3 or worse were reported in seven (8%) of 85 patients in the icotinib group and 28 (38%) of 73 patients in the WBI group. Raised concentrations of alanine aminotransferase and rash were the most common adverse events of any grade in both groups, occurring in around 20-30% of each group. At the time of final analysis, 42 (49%) patients in the icotinib group and 37 (51%) in the WBI group had died. 78 of these patients died from disease progression, and one patient in the WBI group died from thrombogenesis related to chemotherapy. In patients with EGFR-mutant NSCLC and multiple brain metastases, icotinib was associated with significantly longer intracranial PFS than WBI plus chemotherapy, indicating that icotinib might be a better first-line therapeutic option for this patient population. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine, National Health and Family Planning Commission of China, Guangzhou Science and Technology Bureau, Betta Pharmaceuticals, and the Chinese Thoracic Oncology Group. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Efficacy and safety profile of memantine in patients with cognitive impairment in multiple sclerosis: A randomized, placebo-controlled study.

    PubMed

    Peyro Saint Paul, Laure; Creveuil, Christian; Heinzlef, Olivier; De Seze, Jerome; Vermersch, Patrick; Castelnovo, Giovanni; Cabre, Philippe; Debouverie, Marc; Brochet, Bruno; Dupuy, Benoit; Lebiez, Pierre; Sartori, Éric; Clavelou, Pierre; Brassat, David; Lebrun-Frenay, Christine; Daplaud, David; Pelletier, Jean; Coman, Irène; Hautecoeur, Patrick; Tourbah, Ayman; Defer, Gilles

    2016-04-15

    Memantine, an uncompetitive antagonist of N-methyl-D-aspartate (NMDA)-type glutamate receptors that was approved for the treatment of moderate to severe Alzheimer's disease, has been negatively evaluated for the treatment of cognitive disorders of multiple sclerosis, but these studies were conducted only during short-term administration and on a heterogeneous group of patients with different forms of the disease. In addition, many adverse reactions were observed in these patients. The purpose of the "EMERITE" (NCT01074619) study was to examine the efficacy and safety of the long-term administration of memantine as a symptomatic treatment for cognitive disorders in patients with relapsing-remitting multiple sclerosis (RR-MS). The study was supported by the French Ministry of Health and received additional support from Lundbeck. In this double-blind, placebo-controlled, parallel group, randomized trial, the participants were assigned to receive memantine (20 mg/day) or a placebo for 52 weeks. The participants included males and females, 18-60 years of age, with a diagnosis of RR-MS and presenting with a cognitive complaint and/or demonstrating moderate cognitive impairment. The data were collected in the Department of Neurology in 19 French centers. The primary outcome was the Paced Auditory Serial Addition Test (PASAT) score at week 52. Secondary measurements included additional neuropsychological tests and the annualized relapse rate. The scores were adjusted according to the baseline scores in the analysis. The safety was assessed by the number of adverse events. The random sequence was generated using the Excel software. At each center, only the pharmacist had access to the allocation sequence and could be asked to unblind the trial. Fifty patients were allocated to the memantine group, and 43 to the placebo group. The intent-to-treat (ITT) population included 31 patients in each group. After adjusting for the PASAT scores at baseline, the PASAT scores at the end point did not differ between the memantine and the placebo groups (p=0.88). Adjusted mean score difference (memantine minus placebo), was -0.40 (95% confidence interval: -5.5; +4.7). No significant differences were observed for the secondary outcomes (short term memory and attention scores, EDSS, and relapse rate). The findings remained unchanged after multiple imputation of the missing values. Neurological and psychiatric adverse events were significantly higher in the memantine group than in the placebo group, and these parameters were higher than those reported in the product literature of memantine. No differences between the placebo and memantine groups were observed. Nevertheless, the tolerability of memantine was significantly worse than expected. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain.

    PubMed

    Chye, Cien-Leong; Liang, Cheng-Loong; Lu, Kang; Chen, Ya-Wen; Liliang, Po-Chou

    2015-01-01

    Chronic hip pain is a common symptom experienced by many people. Often, surgery is not an option for patients with multiple comorbidities, and conventional drugs either have many side effects or are ineffective. Pulsed radiofrequency (PRF) is a new method in the treatment of pain. We attempt to compare the efficacy of PRF relative to conservative management for chronic hip pain. Between August 2011 and July 2013, 29 patients with chronic hip pain were divided into two groups (PRF and conservative treatment) according to consent or refusal to undergo PRF procedure. Fifteen patients received PRF of the articular branches of the femoral and obturator nerves, and 14 patients received conservative treatment. Visual analog scale (VAS), Oxford hip scores (OHS), and pain medications were used for outcome measurement before treatment and at 1 week, 4 weeks, and 12 weeks after treatment. At 1 week, 4 weeks, and 12 weeks after treatment initiation, improvements in VAS were significantly greater with PRF. Improvements in OHS were significantly greater in the PRF group at 1 week, 4 weeks, and 12 weeks. Patients in the PRF group also used less pain medications. Eight subjects in the conservative treatment group switched to the PRF group after 12 weeks, and six of them had >50% improvement. When compared with conservative treatment, PRF of the articular branches of the femoral and obturator nerves offers greater pain relief for chronic hip pain and can augment physical functioning.

  4. Treatment strategies for women with WHO group II anovulation: systematic review and network meta-analysis

    PubMed Central

    Kim, Bobae V; van Wely, Madelon; Johnson, Neil P; Costello, Michael F; Zhang, Hanwang; Ng, Ernest Hung Yu; Legro, Richard S; Bhattacharya, Siladitya; Norman, Robert J; Mol, Ben Willem J

    2017-01-01

    Objective To compare the effectiveness of alternative first line treatment options for women with WHO group II anovulation wishing to conceive. Design Systematic review and network meta-analysis. Data sources Cochrane Central Register of Controlled Trials, Medline, and Embase, up to 11 April 2016. Study selection Randomised controlled trials comparing eight ovulation induction treatments in women with WHO group II anovulation: clomiphene, letrozole, metformin, clomiphene and metformin combined, tamoxifen, gonadotropins, laparoscopic ovarian drilling, and placebo or no treatment. Study quality was measured on the basis of the methodology and categories described in the Cochrane Collaboration Handbook. Pregnancy, defined preferably as clinical pregnancy, was the primary outcome; live birth, ovulation, miscarriage, and multiple pregnancy were secondary outcomes. Results Of 2631 titles and abstracts initially identified, 57 trials reporting on 8082 women were included. All pharmacological treatments were superior to placebo or no intervention in terms of pregnancy and ovulation. Compared with clomiphene alone, both letrozole and the combination of clomiphene and metformin showed higher pregnancy rates (odds ratio 1.58, 95% confidence interval 1.25 to 2.00; 1.81, 1.35 to 2.42; respectively) and ovulation rates (1.99, 1.38 to 2.87; 1.55, 1.02 to 2.36; respectively). Letrozole led to higher live birth rates when compared with clomiphene alone (1.67, 1.11 to 2.49). Both letrozole and metformin led to lower multiple pregnancy rates compared with clomiphene alone (0.46, 0.23 to 0.92; 0.22, 0.05 to 0.92; respectively). Conclusions In women with WHO group II anovulation, letrozole and the combination of clomiphene and metformin are superior to clomiphene alone in terms of ovulation and pregnancy. Compared with clomiphene alone, letrozole is the only treatment showing a significantly higher rate of live birth. Systematic review registration PROSPERO CRD42015027579. PMID:28143834

  5. Evaluation of Gastrointestinal Leakage in Multiple Enteric Inflammation Models in Chickens

    PubMed Central

    Kuttappan, Vivek A.; Vicuña, Eduardo A.; Latorre, Juan D.; Wolfenden, Amanda D.; Téllez, Guillermo I.; Hargis, Billy M.; Bielke, Lisa R.

    2015-01-01

    Enteric inflammation models can help researchers’ study methods to improve health and performance and evaluate various growth promoters and dietary formulations targeted to improve performance in poultry. Oral administration of fluorescein isothiocyanate-dextran (FITC-d; 3–5 kDa) and its pericellular mucosal epithelial leakage are an established marker to evaluate enteric inflammation in multiple species. The present study evaluated different methods to induce gut inflammation in poultry based on FITC-d leakage. Four independent experiments were completed with different inflammation treatment groups, and serum FITC-d and/or retention of FITC-d in GI tract were determined. In experiment 1 (n = 10 birds/treatment, broilers, processed at 14 days), groups included control (CON), dextran sodium sulfate (DSS; drinking water at 0.75%) and feed restriction (FRS; 24 h before processing). Experiment 2 (n = 14 birds/treatment, leghorns, processed at 7 days) included CON, DSS, FRS, and rye-based diet (RBD). In experiments 3 and 4 (n = 15 birds/treatment, broilers, processed at 7 days), groups were CON, DSS, high fat diet (HFD), FRS, and RBD. In all experiments, FRS and RBD treatments showed significantly higher serum FITC-d levels compared to the respective CON. This indicates that FRS and RBD results in disruption of the intact barrier of the gastrointestinal tract (GIT), resulting in increased gut permeability. DSS and HFD groups showed elevation of serum FITC-d levels although the magnitude of difference from respective CON was inconsistent between experiments. FRS was the only treatment which consistently showed elevated retention of FITC-d in GIT in all experiments. The results from present studies showed that FRS and RBD, based on serum FITC-d levels, can be robust models to induce gut leakage in birds in different age and species/strains. PMID:26697435

  6. Applying Metabolomics to differentiate amphibian responses ...

    EPA Pesticide Factsheets

    Introduction/Objectives/Methods One of the biggest challenges in ecological risk assessment is determining the impact of multiple stressors on individual organisms and populations in ‘real world’ scenarios. Emerging ‘omic technologies, notably, metabolomics, provides an opportunity to address the uncertainties surrounding ecological risk assessment of multiple stressors. The objective of this study was to use a metabolomics biomarker approach to investigate the effect of multiple stressors on amphibian metamorphs. To this end, metamorphs of Rana pipiens (northern leopard frogs) were exposed to the insecticide Carbaryl (0.32 μg/L), a conspecific predator alarm call (Lithobates catesbeianus), Carbaryl and the predator alarm call, and a control with no stressor. In addition to metabolomic fingerprinting, we measured corticosterone levels in each treatment to assess general stress response. We analyzed relative abundances of endogenous metabolites collected in liver tissue with gas chromatography coupled with mass spectrometry. Support vector machine (SVM) methods with recursive feature elimination (RFE) were applied to rank the metabolomic profiles produced. Results/Conclusions SVM-RFE of the acquired metabolomic spectra demonstrated 85-96% classification accuracy among control and all treatment groups when using the top 75 ranked retention time bins. Biochemical fluxes observed in the groups exposed to carbaryl, predation threat, and the combined treatmen

  7. One session treatment for specific phobias in children: Comorbid anxiety disorders and treatment outcome.

    PubMed

    Ryan, Sarah M; Strege, Marlene V; Oar, Ella L; Ollendick, Thomas H

    2017-03-01

    One-Session Treatment (OST) for specific phobias has been shown to be effective in reducing phobia severity; however, the effect of different types of co-occurring anxiety disorders on OST outcomes is unknown. The present study examined (1) the effects of co-occurring generalized anxiety disorder (GAD), social anxiety disorder (SAD), or another non-targeted specific phobia (OSP) on the efficacy of OST for specific phobias, and (2) the effects of OST on these co-occurring disorders following treatment. Three groups of 18 youth (7-15 years) with a specific phobia and comorbid GAD, SAD, or OSP were matched on age, gender, and phobia type. Outcome measures included diagnostic status and severity, and clinician rated improvement. All groups demonstrated an improvement in their specific phobia following treatment. Treatment was equally effective regardless of co-occurring anxiety disorder. In addition, comorbid anxiety disorders improved following OST; however, this effect was not equal across groups. The SAD group showed poorer improvement in their comorbid disorder than the GAD group post-treatment. However, the SAD group continued to improve and this differential effect was not evident six-months following treatment. The current study sample was small, with insufficient power to detect small and medium effect sizes. Further, the sample only included a portion of individuals with primary GAD or SAD, which may have attenuated the findings. The current study demonstrated that co-occurring anxiety disorders did not interfere with phobia treatment. OST, despite targeting a single specific phobia type, significantly reduced comorbid symptomatology across multiple anxiety disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Comparison of inguinal approach, scrotal sclerotherapy and subinguinal antegrade sclerotherapy in varicocele treatment: a randomized prospective study.

    PubMed

    Fayez, A; El Shantaly, K M; Abbas, M; Hauser, S; Müller, S C; Fathy, A

    2010-01-01

    We compared outcome and complications of three simple varicocelectomy techniques. Groups were divided according to whether they would receive the Ivanissevich technique (n = 55), Tauber's technique (n = 51) or subinguinal sclerotherapy (n = 49). Selection criteria were: infertility >1 year, subnormal semen, sonographic diameter of veins >3 mm and time of regurge >2 s. Patients were randomly assigned to the groups of treatment, with follow-up every 3 months for 1 year. Improvement was only in sperm count and total motility for all groups. Pregnancy rates were 20, 13.73 and 12.24%, respectively, with no significant difference between groups. Hydrocele occurred only in the group which received the Ivanissevich technique (5.5%). Tauber's technique is simple; however, it has the disadvantage of multiple branching of small veins. Copyright © 2010 S. Karger AG, Basel.

  9. A geometrically based method for automated radiosurgery planning.

    PubMed

    Wagner, T H; Yi, T; Meeks, S L; Bova, F J; Brechner, B L; Chen, Y; Buatti, J M; Friedman, W A; Foote, K D; Bouchet, L G

    2000-12-01

    A geometrically based method of multiple isocenter linear accelerator radiosurgery treatment planning optimization was developed, based on a target's solid shape. Our method uses an edge detection process to determine the optimal sphere packing arrangement with which to cover the planning target. The sphere packing arrangement is converted into a radiosurgery treatment plan by substituting the isocenter locations and collimator sizes for the spheres. This method is demonstrated on a set of 5 irregularly shaped phantom targets, as well as a set of 10 clinical example cases ranging from simple to very complex in planning difficulty. Using a prototype implementation of the method and standard dosimetric radiosurgery treatment planning tools, feasible treatment plans were developed for each target. The treatment plans generated for the phantom targets showed excellent dose conformity and acceptable dose homogeneity within the target volume. The algorithm was able to generate a radiosurgery plan conforming to the Radiation Therapy Oncology Group (RTOG) guidelines on radiosurgery for every clinical and phantom target examined. This automated planning method can serve as a valuable tool to assist treatment planners in rapidly and consistently designing conformal multiple isocenter radiosurgery treatment plans.

  10. Mesenchymal stem cells can modulate longitudinal changes in cortical thickness and its related cognitive decline in patients with multiple system atrophy

    PubMed Central

    Sunwoo, Mun Kyung; Yun, Hyuk Jin; Song, Sook K.; Ham, Ji Hyun; Hong, Jin Yong; Lee, Ji E.; Lee, Hye S.; Sohn, Young H.; Lee, Jong-Min; Lee, Phil Hyu

    2014-01-01

    Multiple system atrophy (MSA) is an adult-onset, sporadic neurodegenerative disease. Because the prognosis of MSA is fatal, neuroprotective or regenerative strategies may be invaluable in MSA treatment. Previously, we obtained clinical and imaging evidence that mesenchymal stem cell (MSC) treatment could have a neuroprotective role in MSA patients. In the present study, we evaluated the effects of MSC therapy on longitudinal changes in subcortical deep gray matter volumes and cortical thickness and their association with cognitive performance. Clinical and imaging data were obtained from our previous randomized trial of autologous MSC in MSA patients. During 1-year follow-up, we assessed longitudinal differences in automatic segmentation-based subcortical deep gray matter volumes and vertex-wise cortical thickness between placebo (n = 15) and MSC groups (n = 11). Next, we performed correlation analysis between the changes in cortical thickness and changes in the Korean version of the Montreal Cognitive Assessment (MoCA) scores and cognitive performance of each cognitive subdomain using a multiple, comparison correction. There were no significant differences in age at baseline, age at disease onset, gender ratio, disease duration, clinical severity, MoCA score, or education level between the groups. The automated subcortical volumetric analysis revealed that the changes in subcortical deep gray matter volumes of the caudate, putamen, and thalamus did not differ significantly between the groups. The areas of cortical thinning over time in the placebo group were more extensive, including the frontal, temporal, and parietal areas, whereas these areas in the MSC group were less extensive. Correlation analysis indicated that declines in MoCA scores and phonemic fluency during the follow-up period were significantly correlated with cortical thinning of the frontal and posterior temporal areas and anterior temporal areas in MSA patients, respectively. In contrast, no significant correlations were observed in the MSC group. These results suggest that MSC treatment in patients with MSA may modulate cortical thinning over time and related cognitive performance, inferring a future therapeutic candidate for cognitive disorders. PMID:24982631

  11. Idiopathic hypersomnia: a study of 77 cases.

    PubMed

    Anderson, Kirstie N; Pilsworth, Samantha; Sharples, Linda D; Smith, Ian E; Shneerson, John M

    2007-10-01

    To review the clinical and polysomnographic characteristics of idiopathic hypersomnia as well as the long-term response to treatment. The Respiratory Support and Sleep Centre at Papworth Hospital, Cambridge, UK. A large database of more than 6000 patients with sleep disorders was reviewed. A retrospective study of the clinical and polysomnographic characteristics of 77 patients with idiopathic hypersomnia was performed. Comparison with a similar group of patients with narcolepsy was performed. The response to drug treatment was assessed in 61 patients over a mean follow-up of 3.8 years. Idiopathic hypersomnia was 60% as prevalent as narcolepsy. Comparison with a similar group of patients with narcolepsy showed that those with idiopathic hypersomnia were more likely to have prolonged unrefreshing daytime naps, a positive family history, increased slow-wave sleep, and a longer sleep latency on the Multiple Sleep Latency Test. The results of the Multiple Sleep Latency Test were not helpful in predicting disease severity or treatment response. The clinical features were heterogeneous and of variable severity. The majority of patients with idiopathic hypersomnia had symptoms that remained stable over many years, but 11% had spontaneous remission, which was never seen in narcolepsy. Two thirds of patients with idiopathic hypersomnolence had a sustained improvement in daytime somnolence with medication, although a third needed high doses or combinations of drugs. Idiopathic hypersomnolence has characteristic clinical and polysomnographic features but the prolonged latency on the Multiple Sleep Latency Test raises doubt about the validity of this test within the current diagnostic criteria. The disease often responds well to treatment and a substantial minority of patients appear to spontaneously improve.

  12. Aromatherapy massage on the abdomen for alleviating menstrual pain in high school girls: a preliminary controlled clinical study.

    PubMed

    Hur, Myung-Haeng; Lee, Myeong Soo; Seong, Ka-Yeon; Lee, Mi-Kyoung

    2012-01-01

    This study investigated the alleviating effects of aromatherapy massage and acetaminophen on menstrual pain in Korean high school girls. Subjects were divided into two groups: the aromatherapy massage (treatment) group (n = 32) and the acetaminophen (control) group (n = 23). Aromatherapy massage was performed on subjects in the treatment group. The abdomen was massaged once using clary sage, marjoram, cinnamon, ginger, and geranium in a base of almond oil. The level of menstrual pain was assessed using a visual analogue scale at baseline and twenty-four hours afterward. The reduction of menstrual pain was significantly higher in the aromatherapy group than in the acetaminophen group. Using multiple regression, aromatherapy massage was found to be more highly associated with reduction in the level of menstrual pain than acetaminophen. These finding suggest that aromatherapy massage may be an effective treatment for menstrual pain in high school girls. However, it could not be verified whether the positive effects derived from the aromatherapy, the massage, or both. Further rigorous studies should be conducted using more objective measures.

  13. Aromatherapy Massage on the Abdomen for Alleviating Menstrual Pain in High School Girls: A Preliminary Controlled Clinical Study

    PubMed Central

    Hur, Myung-Haeng; Lee, Myeong Soo; Seong, Ka-Yeon; Lee, Mi-Kyoung

    2012-01-01

    This study investigated the alleviating effects of aromatherapy massage and acetaminophen on menstrual pain in Korean high school girls. Subjects were divided into two groups: the aromatherapy massage (treatment) group (n = 32) and the acetaminophen (control) group (n = 23). Aromatherapy massage was performed on subjects in the treatment group. The abdomen was massaged once using clary sage, marjoram, cinnamon, ginger, and geranium in a base of almond oil. The level of menstrual pain was assessed using a visual analogue scale at baseline and twenty-four hours afterward. The reduction of menstrual pain was significantly higher in the aromatherapy group than in the acetaminophen group. Using multiple regression, aromatherapy massage was found to be more highly associated with reduction in the level of menstrual pain than acetaminophen. These finding suggest that aromatherapy massage may be an effective treatment for menstrual pain in high school girls. However, it could not be verified whether the positive effects derived from the aromatherapy, the massage, or both. Further rigorous studies should be conducted using more objective measures. PMID:21949670

  14. Effect of p27 gene combined with Pientzehuang ([characters: see text]) on tumor growth in osteosarcoma-bearing nude mice.

    PubMed

    Ren, Shou-song; Yuan, Fang; Liu, Ying-hong; Zhou, Le-tian; Li, Jun

    2015-11-01

    To observe the effect of p27 gene recombinant adenovirus combined with Chinese medicine Pientzehuang ([characters: see text]) on the growth of xenografted human osteosarcoma in nude mice. Tissue transplantation was used to construct the orthotopic model of human osteosarcoma Saos-2 cell in nude mice. Thirty tumor-bearing nude mice were randomly divided into 5 groups with 6 mice in each group: blank control group (model of osteosarcoma), empty vector group (recombinant adeno-associated virus-multiple cloning site), Pientzehuang group, p27 gene group and combined treatment group (p27 gene combined with Pientzehuang). The effect of combined treatment on human osteosarcoma was analyzed through the tumor formation, tumor volume and inhibition rate of tumor growth. The expression of p27 was measured by immunohistochemical staining and Western blot. The orthotopic model of osteosarcoma in nude mice was successfully constructed. The general appearance of tumor-bearing nude mice in Pientzehuang and p27 gene groups was markedly improved compared with the blank control group; and in the combined treatment group it was significantly improved compared with the Pientzehuang and p27 gene groups. The tumor growth in the Pientzehuang and p27 gene groups was significantly inhibited compared with the blank control group P<0.05); while in the combined treatment group it was markedly inhibited compared with the Pientzehuang and p27 gene groups (P<0.05). The rates of tumor growth inhibition were 34.1%, 56.5% and 63.8% in the Pientzehuang, p27 gene and combined treatment groups, respectively. Meanwhile, the protein expression of p27 gene in the p27 gene group was significantly increased compared with the blank control group (P<0.05); and it was significantly increased in the combined treatment group compared with the p27 gene and Pientzehuang groups (P<0.05). p27 gene introduced by adenovirus combined with Pientzehuang can inhibit the growth of human osteosarcoma cell Saos-2 in nude mice.

  15. Interactive effects of an insecticide and a fungicide on different organism groups and ecosystem functioning in a stream detrital food web.

    PubMed

    Dawoud, Mohab; Bundschuh, Mirco; Goedkoop, Willem; McKie, Brendan G

    2017-05-01

    Freshwater ecosystems are often affected by cocktails of multiple pesticides targeting different organism groups. Prediction and evaluation of the ecosystem-level effects of these mixtures is complicated by the potential not only for interactions among the pesticides themselves, but also for the pesticides to alter biotic interactions across trophic levels. In a stream microcosm experiment, we investigated the effects of two pesticides targeting two organism groups (the insecticide lindane and fungicide azoxystrobin) on the functioning of a model stream detrital food web consisting of a detritivore (Ispoda: Asellus aquaticus) and microbes (an assemblage of fungal hyphomycetes) consuming leaf litter. We assessed how these pesticides interacted with the presence and absence of the detritivore to affect three indicators of ecosystem functioning - leaf decomposition, fungal biomass, fungal sporulation - as well as detritivore mortality. Leaf decomposition rates were more strongly impacted by the fungicide than the insecticide, reflecting especially negative effects on leaf processing by detritivores. This result most like reflects reduced fungal biomass and increased detritivore mortality under the fungicide treatment. Fungal sporulation was elevated by exposure to both the insecticide and fungicide, possibly representing a stress-induced increase in investment in propagule dispersal. Stressor interactions were apparent in the impacts of the combined pesticide treatment on fungal sporulation and detritivore mortality, which were reduced and elevated relative to the single stressor treatments, respectively. These results demonstrate the potential of trophic and multiple stressor interactions to modulate the ecosystem-level impacts of chemicals, highlighting important challenges in predicting, understanding and evaluating the impacts of multiple chemical stressors on more complex food webs in situ. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Renal stone composition does not affect the outcome of percutaneous nephrolithotomy in children.

    PubMed

    Kaygısız, Onur; Türegün, Fethi Ahmet; Satar, Nihat; Özen, Ender; Toksöz, Serdar; Doğan, Hasan Serkan; Pişkin, Mehmet Mesut; İzol, Volkan; Sarıkaya, Şaban; Kılıçarslan, Hakan; Çiçek, Tufan; Öztürk, Ahmet; Tekgül, Serdar; Önal, Bülent

    2018-05-14

    We sought to investigate the association between renal stone composition and percutaneous nephrolithotomy outcomes in pediatric patients and define the characterization of the stone composition. The data of 1157 children who underwent percutaneous nephrolithotomy between 1991 and 2012 were retrieved from the multicenter database of the Turkish Pediatric Urology Society. The study population comprised 359 children (160 girls, 199 boys) with stone analyses. Patients were divided into five groups according to the stone composition [group 1: calcium oxalate; group 2: calcium phosphate; group 3: infection stones (magnesium ammonium phosphate, ammonium urate); group 4: cystine; group 5: uric acid, xanthine stones]. Patient characteristics, perioperative, postoperative, and stone characteristics were compared considering the stone composition. There were no significant differences between the groups concerning age, sex, side involved, preoperative hematocrit levels, and solitary renal unit. Patients with cystine stones were more likely to have a history of stone treatment. Groups 2 and 5 had mostly solitary stones. However, group 3 had staghorn stone more often, and group 4 frequently had multiple stones. Overall stone-free rate (79.4%) was similar among the groups. Although stone composition was related to blood transfusion and prolonged operative and fluoroscopy screening times on univariate analysis, it was not a significant predictor of them on multivariate analysis. Stone composition was not a predictor of outcomes of pediatric percutaneous nephrolithotomy. However, cystine and infection stones, which are larger and filled multiple calyxes due to the nature of stone forming, were more challenging cases that need multiple tracts.

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

    PubMed

    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 < 0.001). 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.

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

    PubMed Central

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

    2014-01-01

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

  19. The effects of pilates on balance, mobility and strength in patients with multiple sclerosis.

    PubMed

    Guclu-Gunduz, Arzu; Citaker, Seyit; Irkec, Ceyla; Nazliel, Bijen; Batur-Caglayan, Hale Zeynep

    2014-01-01

    Although there are evidences as to Pilates developing dynamic balance, muscle strength and flexibility in healthy people, evidences related to its effects on Multiple Sclerosis patients are insufficient. The aims of this study were to investigate the effects of Pilates on balance, mobility, and strength in ambulatory patients with Multiple Sclerosis. Twenty six patients were divided into two groups as experimental (n = 18) and control (n = 8) groups for an 8-week treatment program. The experimental group underwent Pilates and the control group did abdominal breathing and active extremity exercises at home. Balance and mobility were measured with Berg Balance Scale and Timed up and go test, upper and lower muscle strength with hand-held dynamometer. Confidence in balance skills while performing daily activities was evaluated with Activities Specific Balance Confidence Scale. Improvements were observed in balance, mobility, and upper and lower extremity muscle strength in the Pilates group (p < 0.05). No significant differences in any outcome measures were observed in the control group (p > 0.05). Due to its structure which is made up of balance and strengthening exercises, Pilates training may develop balance, mobility and muscle strength of MS patients. For this reason, we think that, Pilates exercises which are appropriate for the disability level of the patient may be suggested.

  20. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study.

    PubMed

    Kappos, Ludwig; Bar-Or, Amit; Cree, Bruce A C; Fox, Robert J; Giovannoni, Gavin; Gold, Ralf; Vermersch, Patrick; Arnold, Douglas L; Arnould, Sophie; Scherz, Tatiana; Wolf, Christian; Wallström, Erik; Dahlke, Frank

    2018-03-31

    No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor 1,5 modulator, on disability progression in patients with SPMS. This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18-60 years) with SPMS and an Expanded Disability Status Scale score of 3·0-6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. 1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65-0·95; relative risk reduction 21%; p=0·013). Adverse events occurred in 975 (89%) of 1099 patients receiving siponimod versus 445 (82%) of 546 patients receiving placebo; serious adverse events were reported for 197 (18%) patients in the siponimod group versus 83 (15%) patients in the placebo group. Lymphopenia, increased liver transaminase concentration, bradycardia and bradyarrhythmia at treatment initiation, macular oedema, hypertension, varicella zoster reactivation, and convulsions occurred more frequently with siponimod than with placebo. Initial dose titration mitigated cardiac first-dose effects. Frequencies of infections, malignancies, and fatalities did not differ between groups. Siponimod reduced the risk of disability progression with a safety profile similar to that of other S1P modulators and is likely to be a useful treatment for SPMS. Novartis Pharma AG. Copyright © 2018 Elsevier Ltd. All rights reserved.

  1. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma.

    PubMed

    Mateos, María-Victoria; Dimopoulos, Meletios A; Cavo, Michele; Suzuki, Kenshi; Jakubowiak, Andrzej; Knop, Stefan; Doyen, Chantal; Lucio, Paulo; Nagy, Zsolt; Kaplan, Polina; Pour, Ludek; Cook, Mark; Grosicki, Sebastian; Crepaldi, Andre; Liberati, Anna M; Campbell, Philip; Shelekhova, Tatiana; Yoon, Sung-Soo; Iosava, Genadi; Fujisaki, Tomoaki; Garg, Mamta; Chiu, Christopher; Wang, Jianping; Carson, Robin; Crist, Wendy; Deraedt, William; Nguyen, Huong; Qi, Ming; San-Miguel, Jesus

    2018-02-08

    The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P<0.001). The overall response rate was 90.9% in the daratumumab group, as compared with 73.9% in the control group (P<0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, versus 24.4% (P<0.001). In the daratumumab group, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 10 5 white cells), as compared with 6.2% of those in the control group (P<0.001). The most common adverse events of grade 3 or 4 were hematologic: neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively). The rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group; the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively. Daratumumab-associated infusion-related reactions occurred in 27.7% of the patients. Among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without daratumumab. The daratumumab-containing regimen was associated with more grade 3 or 4 infections. (Funded by Janssen Research and Development; ALCYONE ClinicalTrials.gov number, NCT02195479 .).

  2. Long-term Outcome of Multiple Small-diameter Drilling Decompression Combined with Hip Arthroscopy versus Drilling Alone for Early Avascular Necrosis of the Femoral Head

    PubMed Central

    Li, Ji; Li, Zhong-Li; Zhang, Hao; Su, Xiang-Zheng; Wang, Ke-Tao; Yang, Yi-Meng

    2017-01-01

    Background: Avascular necrosis of femoral head (AVNFH) typically presents in the young adults and progresses quickly without proper treatments. However, the optimum treatments for early stage of AVNFH are still controversial. This study was conducted to evaluate the therapeutic effects of multiple small-diameter drilling decompression combined with hip arthroscopy for early AVNFH compared to drilling alone. Methods: This is a nonrandomized retrospective case series study. Between April 2006 and November 2010, 60 patients (98 hips) with early stage AVNFH participated in this study. The patients underwent multiple small-diameter drilling decompression combined with hip arthroscopy in 26 cases/43 hips (Group A) or drilling decompression alone in 34 cases/55 hips (Group B). Patients were followed up at 6, 12, and 24 weeks, and every 6 months thereafter. Radiographs were taken at every follow-up, Harris scores were recorded at the last follow-up, the paired t-test was used to compare the postoperative Harris scores. Surgery effective rate of the two groups was compared using the Chi-square test. Results: All patients were followed up for an average of 57.6 months (range: 17–108 months). Pain relief and improvement of hip function were assessed in all patients at 6 months after the surgery. At the last follow-up, Group A had better outcome with mean Harris’ scores improved from 68.23 ± 11.37 to 82.07 ± 2.92 (t = −7.21, P = 0.001) than Group B with mean Harris’ scores improved from 69.46 ± 9.71 to 75.79 ± 4.13 (t = –9.47, P = 0.037) (significantly different: t = –2.54, P = 0.017). The total surgery effective rate was also significantly different between Groups A and B (86.0% vs. 74.5%; χ2 = 3.69, P = 0.02). Conclusion: For early stage of AVNFH, multiple small-diameter drilling decompression combined with hip arthroscopy is more effective than drilling decompression alone. PMID:28584206

  3. In vivo evaluation of the antimutagenic and antigenotoxic effects of β-glucan extracted from Saccharomyces cerevisiae in acute treatment with multiple doses.

    PubMed

    Oliveira, Rodrigo Juliano; Salles, Maria José Sparça; da Silva, Ariane Fernanda; Kanno, Tatiane Yumi Nakamura; Lourenço, Ana Carolina Dos Santos; Leite, Véssia da Silva; Matiazi, Hevenilton José; Pesarini, João Renato; Ribeiro, Lúcia Regina; Mantovani, Mário Sérgio

    2013-09-01

    Ample evidence suggests that cancer is triggered by mutagenic damage and diets or supplements capable of reducing such incidences can be related to the prevention of neoplasy development or to an improvement in life quality of patients who undergo chemotherapy. This research aimed to evaluate the antimutagenic and antigenotoxic activity of β-glucan. We set up 8 experimental groups: control (Group 1), cyclophosphamide (Group 2), Groups 3-5 to assess the effect of β-glucan administration, and Groups 6-8 to evaluate the association between cyclophosphamide and β-glucan. The intraperitonial concentrations of β-glucan used were 100, 150 and 200 mg/kg. Micronucleus and comet assays showed that within the first week of treatment β-glucan presented a damage reduction rate between 100-62.04% and 94.34-59.52% for mutagenic and genotoxic damages, respectively. This activity decreased as the treatment was extended. During the sixth week of treatment antimutagenicity rates were reduced to 59.51-39.83% and antigenotoxicity was not effective. This leads to the conclusion that the efficacy of β-glucan in preventing DNA damage is limited when treatment is extended, and that its use as a chemotherapeutic adjuvant need to be better clarified.

  4. Percutaneous bipolar radiofrequency thermocoagulation for the treatment of lumbar disc herniation.

    PubMed

    Zeng, Zhenhua; Yan, Min; Dai, Yi; Qiu, Weidong; Deng, Shuo; Gu, Xinzhu

    2016-08-01

    Lumbar disc herniation is usually managed with conservative treatment or surgery. However, conservative therapy seldom yields good results, and surgery is associated with multiple complications. This study aimed to assess bipolar radiofrequency thermocoagulation for the treatment of lumbar disc herniation. A total of 168 patients with lumbar disc herniation suitable for radiofrequency thermocoagulation were enrolled and randomized to monopolar radiofrequency thermocoagulation (control group, n=84) or bipolar radiofrequency thermocoagulation (experimental group, n=84) treatment groups. Ablation sites were targeted under CT scan guidance, and consecutive radiofrequency therapy was used. One and two probes were used for monopolar and bipolar thermocoagulation, respectively. Thermocoagulation was achieved at 50°C, 60°C, and 70°C for 60s each, 80°C for 90s, and 92°C for 100s. Symptoms and complications were evaluated using the modified Macnab criteria and Visual Analog Scale at 7, 30, and 180days postoperatively. At 180days, a significantly higher efficacy rate was obtained in the experimental group compared with control patients (91.6% versus 79.7%, P<0.05). No severe complications were occurred in either group. Targeted ablation via bipolar radiofrequency thermocoagulation is efficient for lumbar disc herniation treatment, and should be further explored for broad clinical application. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study

    PubMed Central

    2012-01-01

    Background Treatment options for patients suffering from progressive forms of multiple sclerosis (MS) remain inadequate. Mast cells actively participate in the pathogenesis of MS, in part because they release large amounts of various mediators that sustain the inflammatory network. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. This exploratory study assessed the safety and clinical benefit of masitinib in the treatment of primary progressive MS (PPMS) or relapse-free secondary progressive MS (rfSPMS). Methods Multicenter, randomized, placebo-controlled, proof-of-concept trial. Masitinib was administered orally at 3 to 6 mg/kg/day for at least 12 months, with dose adjustment permitted in event of insufficient response with no toxicity. The primary response endpoint was the change relative to baseline in the multiple sclerosis functional composite score (MSFC). Clinical response was defined as an increase in MSFC score relative to baseline of > 100%. Results Thirty-five patients were randomized to receive masitinib (N = 27) or placebo (N = 8). Masitinib was relatively well tolerated with the most common adverse events being asthenia, rash, nausea, edema, and diarrhea. The overall frequency of adverse events was similar to the placebo group, however, a higher incidence of severe and serious events was associated with masitinib treatment. Masitinib appeared to have a positive effect on MS-related impairment for PPMS and rfSPMS patients, as evidenced by an improvement in MSFC scores relative to baseline, compared with a worsening MSFC score in patients receiving placebo; +103% ± 189 versus -60% ± 190 at month-12, respectively. This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations. A total of 7/22 (32%) assessable masitinib patients reported clinical response following 12 months of treatment (according to the modified intent-to-treat population, observed cases) compared with none in the placebo group. The Expanded Disability Status Scale remained stable for both treatment groups. Conclusion These data suggest that masitinib is of therapeutic benefit to PPMS and rfSPMS patients and could therefore represent an innovative avenue of treatment for this disease. This exploratory trial provides evidence that may support a larger placebo-controlled investigation. PMID:22691628

  6. The effect of temperament on the treatment adherence of bipolar disorder type I.

    PubMed

    Buturak, Sadiye Visal; Emel, Erdogan Bakar; Koçak, Orhan Murat

    2016-01-01

    Treatment adherence is one of the most important factors that may determine treatment response in patients with bipolar disorders (BD). Many factors have been described to be associated with treatment adherence in BD. Temperament that can influence the course of BD will have an impact on treatment adherence. The aim of this study is to investigate temperament effect on treatment adherence in euthymic patients with BD-I. Eighty patients with BD-I participated in the study. A psychiatrist used the Structured Clinical Interview for DSM-IV Axis-I Disorders to determine the diagnosis and co-morbidities. Hamilton Depression and Young Mania Rating Scale were used to detect the remission. We used the Temperament Evaluation of Memphis, Pisa, Paris, San Diego Autoquestionnaire and the 4-item Morisky Medication Adherence Scale to evaluate temperament and treatment adherence, respectively. The study group was divided into two groups as "treatment adherent" and "treatment non-adherent". The cyclothymic and anxious temperament scores of the treatment non-adherent patients with BD-I were significantly higher than those of the treatment adherent group (p < 0.001, p = 0.006, respectively). Multiple linear regression analysis determined that cyclothymic temperament predicted treatment non-adherence (p = 0.009). It should be kept in mind that BD-I patients with cyclothymic temperament may be treatment non-adherent and future studies should explore whether temperament characteristics deteriorate BD-I course by disrupting treatment adherence.

  7. Outcomes of pulmonary metastases in hepatoblastoma--is the prognosis always poor?

    PubMed

    Wanaguru, Dylan; Shun, Albert; Price, Neil; Karpelowsky, Jonathan

    2013-12-01

    Hepatoblastoma is a rare tumour accounting for approximately 1% of all paediatric malignancies. Hepatoblastoma complicated by pulmonary metastatic disease continues to cause management difficulties due to a lack of robust evidence and treatment guidelines. This series is the experience of a tertiary paediatric referral centre. Patients were prospectively enlisted, and their charts were retrospectively reviewed. Thirty-seven patients were treated for hepatoblastoma from 1995 to 2012 inclusive. The overall survival was 34/37(91.9%). Eight patients had lung metastases at diagnosis (LMD) and twenty-nine did not (NLMD). Two-year EFS was 62.5% in the LMD group and 89.3% in the NLMD group (p=0.078). Overall survival in the LMD and NLMD groups was 100% and 89.7%, respectively (p=0.389). Two patients in the LMD group required multiple thoracic resections to achieve cure. Within the NLMD group, two patients developed lung metastases whilst on treatment, and both of these patients died. In this series, children presenting with lung metastases had a higher risk of relapse but excellent overall survival. However, children who developed pulmonary disease during treatment had a poor prognosis. We advocate aggressive surgical treatment of pulmonary hepatoblastoma to achieve cure. © 2013.

  8. The effects of tramadol on postoperative shivering after sevoflurane and remifentanil anesthesia.

    PubMed

    Nakagawa, Taku; Hashimoto, Miki; Hashimoto, Yasunori; Shirozu, Kazuhiro; Hoka, Sumio

    2017-01-03

    Remifentanil has been reported to cause post-anesthetic shivering (PAS). Higher doses of remifentanil reportedly induce more intense PAS. Tramadol, a synthetic opioid that acts at multiple sites, is considered to be an effective treatment for PAS, but the evidence for its therapeutic benefit after remifentanil anesthesia is limited. We investigated the effect of tramadol on the incidence of PAS after remifentanil anesthesia. Sixty-three patients who had undergone upper abdominal surgery under general anesthesia were studied retrospectively. Tramadol was administered at induction of anesthesia. The patients were divided into four groups: HT(+), high dose remifentanil (1-1.5 μg/kg/min) with tramadol; HT(-), high dose remifentanil without tramadol; LT(+), low dose remifentanil (0.15-0.25 μg/kg/min) with tramadol; and LT(-), low dose remifentanil without tramadol. We recorded perioperative changes in nasopharyngeal temperature and episodes of PAS on emergence from anesthesia. The incidences of PAS in both tramadol treatment groups were significantly lower than the groups that did not receive tramadol. Nasopharyngeal temperature after surgery fell significantly more from baseline in the tramadol treatment groups compared with the non-treatment groups. Tramadol administered at induction of anesthesia appears to suppress PAS following remifentanil anesthesia.

  9. [Clinical value of serum presepsin (SCD14-ST) concentration measurement in patients with pesticide poisoning].

    PubMed

    Gao, X; Zhu, B Y; Wang, W Z; He, J Q; Han, D L; Liu, Y J; Meng, H; Xiao, Q M; Liu, X T; Han, Y Y

    2016-05-20

    To investigate the value of serum presepsin concentration measurement in the clinical diagnosis and treatment of patients with pesticide poisoning patients. A total of 160 patients with pesticide poisoning were enrolled as study subjects and divided into moderate organophosphate pesticide poisoning group (40 patients) , severe organophosphate pesticide poisoning group (40 patients) , abamectin pesticide poisoning group (40 patients) , and paraquat poisoning group (40 patients). A total of 20 healthy volunteers were enrolled as the control group. All the patients with poisoning received conventional treatment of pesticide poisoning immediately after admission, and serum presepsin concentration was measured on days 1 (within 24 hours after poisoning) , 3, and 7 of admission, and biochemical and radiological parameters related to the patient's condition were also examined. The patients with a Presepsin concentration of >800 pg/ml on day 1 of admission were randomly divided into conventional treatment group and ulinastatin treatment group, and the treatment outcome was compared between the two groups. Compared with the healthy control group, the groups with pesticide poisoning showed significant increases in serum Presepsin concentrations, with the highest degree of increase on day 1 (P <0.05). The serum Presepsin concentration was positively correlated with alanine aminotransferase, aspartate aminotransferase, creatine kinase, creatine kinase MB, lactate dehydrogenase, serum creatinine, blood urea nitrogen, interleukin-18, and white blood cell count, but negatively correlated with cholinesterase. In the conventional treatment group and ulinastatin treatment group, the overall response rate was 68% and 78.8%, respectively, with a significant difference between the two groups (P<0.05). In 40 patients with paraquat poisoning, 32 experienced an increase in serum presepsin concentration, and among these 32 patients, 27 (83%) experienced exudation on lung CT. Serum Presepsin concentration measurement can assist early diagnosis, evaluation of disease severity, and guidance for clinical medication in patients with pesticide poisoning, especially in those with severe pesticide poisoning and a tendency to multiple organ failure.

  10. Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study

    PubMed Central

    2012-01-01

    Background Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. Methods One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n = 50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Results Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Conclusions Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients. PMID:22823904

  11. Comparison of plan quality and delivery time between volumetric arc therapy (RapidArc) and Gamma Knife radiosurgery for multiple cranial metastases.

    PubMed

    Thomas, Evan M; Popple, Richard A; Wu, Xingen; Clark, Grant M; Markert, James M; Guthrie, Barton L; Yuan, Yu; Dobelbower, Michael C; Spencer, Sharon A; Fiveash, John B

    2014-10-01

    Volumetric modulated arc therapy (VMAT) has been shown to be feasible for radiosurgical treatment of multiple cranial lesions with a single isocenter. To investigate whether equivalent radiosurgical plan quality and reduced delivery time could be achieved in VMAT for patients with multiple intracranial targets previously treated with Gamma Knife (GK) radiosurgery. We identified 28 GK treatments of multiple metastases. These were replanned for multiarc and single-arc, single-isocenter VMAT (RapidArc) in Eclipse. The prescription for all targets was standardized to 18 Gy. Each plan was normalized for 100% prescription dose to 99% to 100% of target volume. Plan quality was analyzed by target conformity (Radiation Therapy Oncology Group and Paddick conformity indices [CIs]), dose falloff (area under the dose-volume histogram curve), as well as the V4.5, V9, V12, and V18 isodose volumes. Other end points included beam-on and treatment time. Compared with GK, multiarc VMAT improved median plan conformity (CIVMAT = 1.14, CIGK = 1.65; P < .001) with no significant difference in median dose falloff (P = .269), 12 Gy isodose volume (P = .500), or low isodose spill (P = .49). Multiarc VMAT plans were associated with markedly reduced treatment time. A predictive model of the 12 Gy isodose volume as a function of tumor number and volume was also developed. For multiple target stereotactic radiosurgery, 4-arc VMAT produced clinically equivalent conformity, dose falloff, 12 Gy isodose volume, and low isodose spill, and reduced treatment time compared with GK. Because of its similar plan quality and increased delivery efficiency, single-isocenter VMAT radiosurgery may constitute an attractive alternative to multi-isocenter radiosurgery for some patients.

  12. Estimating virus occurrence using Bayesian modeling in multiple drinking water systems of the United States

    EPA Science Inventory

    Drinking water treatment plants rely on purification of contaminated source waters to provide communities with potable water. One group of possible contaminants are enteric viruses. Measurement of viral quantities in environmental water systems are often performed using polymeras...

  13. DIFFERENTIATING TOXICITIES OF CONAZOLE FUNGICIDES THROUGH METABONOMIC ANALYSES OF MULTIPLE TISSUES

    EPA Science Inventory

    The conazole fungicides represent a large group of compounds widely used agriculturally for the protection of crop plants (Hutson 1998) and pharmaceutically in the treatment of topical and systemic infections (Sheehan 1999). In 1999, the latest period for which agricultural usage...

  14. DIFFERENTIATING TOXICITIES OF CONAZOLE FUNGICIDES THROUGH METABONOMIC ANALYSES OF MULTIPLE TISSUES

    EPA Science Inventory

    The conazole fungicides represent a large group of compounds widely used agriculturally for the protection of crop plants (Hutson 1998) and pharmaceutically in the treatment of topical and systemic infections(Sheehan 1999). In 1999, the latest period for which agricultural usage...

  15. Associations between social identity diversity, compatibility, and recovery capital amongst young people in substance use treatment.

    PubMed

    Mawson, E; Best, D; Lubman, D I

    2016-12-01

    This study explored associations between group memberships and recovery capital amongst 20 young adults aged 18 to 21 years in residential alcohol and drug treatment. Participants completed an interviewer administered research interview based on measures of recovery capital and a social networks assessment mapping group memberships, group substance use, and relationships between groups. Higher personal and social recovery capital was associated with lower diversity of group memberships, a higher number of positive links between groups, and greater compatibility of lower substance-using groups with other groups in the network. Higher compatibility of heavier-using groups was also associated with having a higher number of negative, antagonistic ties between groups. These findings indicate that it is higher compatibility of a lower substance-using social identity and lower-using group memberships that contributes to recovery capital. Further, positive ties between groups and lower diversity of group memberships appear to be key aspects in how multiple social identities that are held by young adults relate to personal and social recovery capital.

  16. Discordances originated by multiple meta-analyses on interventions for myocardial infarction: a systematic review.

    PubMed

    Lucenteforte, Ersilia; Moja, Lorenzo; Pecoraro, Valentina; Conti, Andrea A; Conti, Antonio; Crudeli, Elena; Galli, Alessio; Gensini, Gian Franco; Minnelli, Martina; Mugelli, Alessandro; Proietti, Riccardo; Shtylla, Jonida; D'Amico, Roberto; Parmelli, Elena; Virgili, Gianni

    2015-03-01

    To clarify the impact of multiple (covering the same population, intervention, control, and outcomes) systematic reviews (SRs) on interventions for myocardial infarction (MI). Clinical Evidence (BMJ Group) sections and related search strategies regarding MI were used to identify multiple SRs published between 1997 and 2007. Multiple SRs were classified as discordant if they featured conflicting results or interpretation of them. Thirty-six SRs (23.5% of 153 on the treatment or prevention of MI) were classified as multiple and grouped in 16 clusters [ie, at least two SRs with the same PICO (population, condition/disease, intervention, control) and at least one common outcome] exploring angioplasty, angiotensin-converting enzyme inhibitors, anticoagulants, antiplatelets, β-blockers, and stents. Complete agreement on statistically significant differences between interventions was found in 7 of 10 clusters with a shared composite outcome. Agreement was reduced when single outcomes were considered. Despite substantial variation and limited agreement in reporting of major outcomes, SRs agreed in their conclusions on the superiority of either the intervention or control in 14 of 16 clusters. Sources of minor discrepancies were found in terms of study and outcome selection, subgroup analyses, and interpretation of findings. Multiple SRs agreed in their qualitative conclusions but not on reporting and on analyses of hard outcomes. Discordance on significance of treatment effects was due to a combination of variation in design with inclusion of different studies and lack of precision for single hard outcomes compared with a composite outcome. Such inconsistencies among SRs could potentially slow the translation of SRs' results to clinical and public health decision making and suggest the need for a broader methodological and clinical agreement on their design. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Gallbladder Duplication: Evaluation, Treatment, and Classification

    DTIC Science & Technology

    2010-02-01

    2009; revised 16 December 2009; accepted 16 December 2009h o th 0 d Key words: Duplicate gallbladder; Hepatobiliary embryology ; Multiple gallbladders...anatomic variations [5]. These three types vary depending upon the embryologic development and occur in the same manner as duplicated gallbladders. Given... embryology and adds a third group that occurs when there is a combination of types 1 and 2 anatomy. The triple combined group occurs from a split in

  18. A Randomised Controlled Trial of Efficacy of Cognitive Rehabilitation in Multiple Sclerosis: A Cognitive, Behavioural, and MRI Study.

    PubMed

    Campbell, J; Langdon, D; Cercignani, M; Rashid, W

    2016-01-01

    Aim. To explore the efficacy of home-based, computerised, cognitive rehabilitation in patients with multiple sclerosis using neuropsychological assessment and advanced structural and functional magnetic resonance imaging (fMRI). Methods. 38 patients with MS and cognitive impairment on the Brief International Cognitive Assessment for MS (BICAMS) were enrolled. Patients were randomised to undergo 45 minutes of computerised cognitive rehabilitation using RehaCom software ( n = 19) three times weekly for six weeks or to a control condition ( n = 19). Neuropsychological and MRI data were obtained at baseline (time 1), following the 6-week intervention (time 2), and after a further twelve weeks (time 3). Cortical activations were explored using fMRI and microstructural changes were explored using quantitative magnetisation transfer (QMT) imaging. Results. The treatment group showed a greater improvement in SDMT gain scores between baseline and time 2 compared to the control group ( p = 0.005). The treatment group exhibited increased activation in the bilateral prefrontal cortex and right temporoparietal regions relative to control group at time 3 ( p < 0.05 FWE  corrected ). No significant changes were observed on QMT. Conclusion. This study supports the hypothesis that home-based, computerised, cognitive rehabilitation may be effective in improving cognitive performance in patients with MS. Clinical trials registration is ISRCTN54901925.

  19. A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue.

    PubMed

    Moss-Morris, Rona; McCrone, Paul; Yardley, Lucy; van Kessel, Kirsten; Wills, Gary; Dennison, Laura

    2012-06-01

    The majority of people affected by Multiple Sclerosis (paMS) experience severe and disabling fatigue. A recent randomised controlled trial (RCT) showed that cognitive behaviour therapy with a clinical psychologist was an effective treatment for MS fatigue. An Internet-based version of this intervention, MS Invigor8, was developed for the current study using agile design and input from paMS. MS Invigor8 includes eight tailored, interactive sessions. The aim was to test the feasibility and potential efficacy and cost-effectiveness of the programme in a pilot RCT. 40 patients were randomised to MS Invigor8 (n=23) or standard care (n=17). The MS Invigor8 group accessed sessions over 8-10 weeks and received up to three 30-60min telephone support sessions. Participants completed online standardised questionnaires assessing fatigue, mood, quality of life and service use at baseline and 10 weeks follow-up. Large between group treatment effects were found for the primary outcomes of fatigue severity (d=1.19) and impact (d=1.02). The MS Invigor8 group also reported significantly greater improvements in anxiety, depression and quality-adjusted life years. These data suggest that Internet-based CBT may be a clinically and cost-effective treatment for MS fatigue. A larger RCT with longer term follow-up is warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Evaluation of a Stage-Based, Computer-Tailored Adjunct to Usual Care for Domestic Violence Offenders

    PubMed Central

    Levesque, Deborah A.; Ciavatta, Mary Margaret; Castle, Patricia H.; Prochaska, Janice M.; Prochaska, James O.

    2012-01-01

    Objective Research assessing the efficacy of court-mandated domestic violence treatment continues to yield inconsistent results. The current study examined whether Journey to Change, a Transtheoretical Model of Behavior Change-based treatment adjunct that consists of three computer-administered sessions and a print guide, could improve outcomes. Method 492 male domestic violence offenders attending court-mandated batterer treatment were assigned to Usual Care (UC) or Usual Care + Journey to Change (UC + Journey). Results Compared to UC, participants receiving UC + Journey were significantly more likely to be in the Action stage at the end of treatment, and to seek help and services outside of group. Based on victim reports, the UC + Journey group was significantly less likely than UC to engage in physical violence during the 12-month follow-up. Both groups were equally likely to drop out of court-mandated treatment and to have further domestic violence-related police involvement. However, among participants with police involvement, the UC + Journey group had lower rates of documented violence and physical injury. Conclusions The pattern of findings across the multiple outcomes suggests that the Journey to Change program holds promise for improving some outcomes for domestic violence offenders in treatment, and warrants further investigation. PMID:23412627

  1. Comparison of single-dose and multiple-dose antibiotics for lower urinary tract infection in pregnancy.

    PubMed

    Usta, Taner A; Dogan, Ozgur; Ates, Ugur; Yucel, Burak; Onar, Zehra; Kaya, Erdal

    2011-09-01

    To compare the efficacy of fosfomycin trometamol, cefuroxime axetil, and amoxicillin clavulanate antibiotics, and to assess the difference in patient compliance, in the treatment of urinary tract infections during pregnancy. Between September 2007 and May 2008, 90 out of 324 pregnant women with complaints of lower urinary tract infection, who were followed at the outpatient clinic or referred to the emergency department of Vakif Gureba Education and Research Hospital, were enrolled in a prospective study. Patients were randomized into 3 equal groups for treatment with single-dose fosfomycin trometamol, or 5-day courses of amoxicillin clavulanate or cefuroxime axetil. After follow-up, study data were obtained for 28, 27, and 29 patients, respectively. The treatment groups did not differ significantly in terms of demographics, clinical success rate, microbiological cure rate, or adverse effects. Significantly higher drug compliance was observed in the fosfomycin trometamol group than in the other 2 groups (P<0.05). Treatment with a single dose of fosfomycin trometamol was as effective for UTI as the standard course of treatment with amoxicillin clavulanate or cefuroxime axetil. Fosfomycin trometamol may be a preferable treatment for UTI because of its simpler use and better rates of compliance. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  2. Randomized controlled trial of a nonpharmacologic cholesterol reduction program at the worksite.

    PubMed

    Bruno, R; Arnold, C; Jacobson, L; Winick, M; Wynder, E

    1983-07-01

    Under experimental clinical conditions diet modification has been shown to reduce serum cholesterol levels. This paper reports such a positive response to a nonpharmacologic, behavioral education program at the worksite. Employees at the New York Telephone Company corporate headquarters were assigned randomly to treatment and control groups. Treatment consisted of an 8-week group cholesterol reduction program conducted during employee lunch hours. It comprised a multiple-treatment approach--food behavior change techniques combined with nutrition education, physical activity planning, and self-management skills. The treatment group showed substantial change compared with the control group at the program's completion. Those treated displayed a significant 6.4% reduction in total serum cholesterol (266 mg% average at baseline) as compared with control subjects with a corresponding decrease in high-density lipoprotein levels. A significant increase in nutrition knowledge and moderate weight loss were also documented for this group. The magnitudes of a participant's baseline serum cholesterol level and his/her reduction in percentage of ideal body weight were positively and independently correlated with percentage changes in serum cholesterol levels. Over the same period, decreases in high-density lipoprotein levels and no changes in serum cholesterol, weight, and nutrition knowledge were observed for the control group. Overall, participants in the treatment program successfully reduced the coronary heart disease risk factors of elevated cholesterol and weight. Directions for future study are suggested.

  3. A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B.

    PubMed

    Schimmel, Wietske C M; Verhaak, Eline; Hanssens, Patrick E J; Gehring, Karin; Sitskoorn, Margriet M

    2018-02-21

    Gamma Knife radiosurgery (GKRS) is increasingly applied in patients with multiple brain metastases and is expected to have less adverse effects in cognitive functioning than whole brain radiation therapy (WBRT). Effective treatment with the least negative cognitive side effects is increasingly becoming important, as more patients with brain metastases live longer due to more and better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple brain metastases that include objective neuropsychological testing. CAR-Study B is a prospective randomised trial comparing cognitive outcome after GKRS or WBRT in adult patients with 11-20 newly diagnosed brain metastases on a contrast-enhanced MRI-scan, KPS ≥70 and life expectancy of at least 3 months. Randomisation by the method of minimization, is stratified by the cumulative tumour volume in the brain, systemic treatment, KPS, histology, baseline cognitive functioning and age. The primary endpoint is the between-group difference in the percentage of patients with significant memory decline at 3 months. Secondary endpoints include overall survival, local control, development of new brain metastases, cognitive functioning over time, quality of life, depression, anxiety and fatigue. Cognitive functioning is assessed by a standardised neuropsychological test battery. Assessments (cognitive testing, questionnaires and MRI-scans) are scheduled at baseline and at 3, 6, 9, 12 and 15 months after treatment. Knowledge gained from this trial may be used to inform individual patients with BM more precisely about the cognitive effects they can expect from treatment, and to assist both doctors and patients in making (shared) individual treatment decisions. This trial is currently recruiting. Target accrual: 23 patients at 3-months follow-up in both groups. The Netherlands Trials Register number NTR5463. ClinicalTrials.gov registration number NCT02953717 , first received October 27, 2016, 8 patients were enrolled in this study on 31 July 2017.

  4. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    PubMed

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  5. Comparison of treatment with continuous subcutaneous insulin infusion versus multiple daily insulin injections with bolus calculator in patients with type 1 diabetes.

    PubMed

    Pérez-García, L; Goñi-Iriarte, M J; García-Mouriz, M

    2015-01-01

    A study of the glycemic control, quality of life, and fear and perception of hypoglycemia by comparing continuous subcutaneous insulin infusion (CSII) group with multiple daily inyections (MDI) with bolus calculator group. This is a retrospective cohort study with following up during the first 12 months that CSII group (n=30) begins the use of "bolus wizard" and the MDI-calculator (n=30) group begins the use of the bolus calculator (Accu-Chek(®) Aviva Expert). HbA1c (3, 6 and 12 months). Questionnaires used: EsDQOL (quality of life), FH-15 (fear of hypoglycemia), and Clarke (perception of hypoglycemia). T Student and nonparametric tests. The average reduction in HbA1c during the study was significantly higher in CSII group (-0.56±0.84%) compared with the MDI group (0.097±0.94%), P=.028. The average basal insulin dose was significantly higher in the MDI group (at baseline, 6 and 12 months). No significant differences were found between the 2 treatment groups after analyzing the EsDQOL, FH-15 and Clarke questionnaires. In the CSII group, perceived quality of life assessed by the EsDQOL questionnaire was found to be better at the end of the study than at the beginning of using the insulin pump. The average reduction in HbA1c was significantly higher in the CSII group. In the CSII group, perceived quality of life was better at the end of the study than at the beginning. Copyright © 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

  6. Multiple-file vs. single-file endodontics in dental practice: a study in routine care.

    PubMed

    Bartols, Andreas; Laux, Gunter; Walther, Winfried

    2016-01-01

    Little is known about the differences of rotary multiple file endodontic therapy and single-file reciprocating endodontic treatment under routine care conditions in dental practice. This multicenter study was performed to compare the outcome of multiple-file (MF) and single-file (SF) systems for primary root canal treatment under conditions of general dental practice regarding reduction of pain with a visual analogue scale (VAS 100), improvement of oral-health-related quality of life (OHRQoL) with the german short version of the oral health impact profile (OHIP-G-14) and the speed of root canal preparation. Ten general dental practitioners (GDPs) participated in the study as practitioner-investigators (PI). In the first five-month period of the study, the GDPs treated patients with MF systems. After that, the GDPs treated the patients in the second five-month period with a SF system (WaveOne). The GDPs documented the clinical findings at the beginning and on completion of treatment. The patients documented their pain and OHRQoL before the beginning and before completion of treatment. A total of 599 patients were included in the evaluation. 280 patients were in the MF group, 319 were in the SF WaveOne group. In terms of pain reduction and improvement in OHIP-G-14, the improvement in both study groups (MF and SF) was very similar based on univariate analysis methods. Pain reduction was 34.4 (SD 33.7) VAS (MF) vs. 35.0 (SD 35.4) VAS (SF) ( p  = 0.840) and the improvement in OHIP-G-14 score was 9.4 (SD 10.3) (MF) vs. 8.5 (SD 10.2) (SF) ( p  = 0.365). The treatment time per root canal was 238.9 s (SD 206.2 s) (MF) vs. 146.8 sec. (SD 452.8 sec) (SF) ( p  = 0.003). Regarding improvement of endodontic pain and OHRQoL measure with OHIP-G-14, there were no statistical significant differences between the SF und the MF systems. WaveOne-prepared root canals significantly faster than MF systems.

  7. Parent Perspectives on the Decision to Initiate Medication Treatment of Attention-Deficit/Hyperactivity Disorder

    PubMed Central

    Pappadopulos, Elizabeth; Katsiotas, Nikki J.; Berest, Alison; Jensen, Peter S.; Kafantaris, Vivian

    2012-01-01

    Abstract Objectives Despite substantial evidence supporting the efficacy of stimulant medication for children with attention-deficit/hyperactivity disorder (ADHD), adherence to stimulant treatment is often suboptimal. Applying social/cognitive theories to understanding and assessing parent attitudes toward initiating medication may provide insight into factors influencing parent decisions to follow ADHD treatment recommendations. This report describes results from formative research that used focus groups to obtain parent input to guide development of a provider-delivered intervention to improve adherence to stimulants. Methods Participants were caregivers of children with ADHD who were given a stimulant treatment recommendation. Focus groups were recorded and transcribed verbatim. Data were analyzed by inductive, grounded theory methods as well as a deductive analytic strategy using an adapted version of the Unified Theory of Behavior Change to organize and understand parent accounts. Results Five groups were conducted with 27 parents (mean child age=9.35 years; standard deviation [SD]=2.00), mean time since diagnosis=3.33 years (SD=2.47). Most parents (81.5%) had pursued stimulant treatment. Inductive analysis revealed 17 attitudes facilitating adherence and 25 barriers. Facilitators included parent beliefs that medication treatment resulted in multiple functional gains and that treatment was imperative for their children's safety. Barriers included fears of personality changes and medication side effects. Complex patterns of parent adherence to medication regimens were also identified, as well as preferences for psychiatrists who were diagnostically expert, gave psychoeducation using multiple modalities, and used a chronic illness metaphor to explain ADHD. Theory-based analyses revealed conflicting expectancies about treatment risks and benefits, significant family pressures to avoid medication, guilt and concern that their children required medication, and distorted ideas about treatment risks. Parents, however, took pride in successfully pursuing efforts to manage their child behaviorally and to avoid medication when possible. Conclusions Focus group data identified social, cognitive, and affective influences on treatment decision making. Results support prior research comparing family/social functioning, physician characteristics, and adherence. Findings suggest that parent attitudes to psychiatric care need to be assessed comprehensively at initial evaluation to aid the development of psychoeducational messages, and a more careful consideration about how parents interpret and respond to adherence-related questioning. PMID:22537185

  8. Anti-inflammatory nutritional intervention in patients with relapsing-remitting and primary-progressive multiple sclerosis: A pilot study

    PubMed Central

    Rossano, Rocco; Larocca, Marilena; Trotta, Vincenzo; Mennella, Ilario; Vitaglione, Paola; Ettorre, Michele; Graverini, Antonio; De Santis, Alessandro; Di Monte, Elisabetta; Coniglio, Maria Gabriella

    2016-01-01

    The aim of this work was to assess the influence of nutritional intervention on inflammatory status and wellness in people with multiple sclerosis. To this end, in a seven-month pilot study we investigated the effects of a calorie-restricted, semi-vegetarian diet and administration of vitamin D and other dietary supplements (fish oil, lipoic acid, omega-3 polyunsaturated fatty acids, resveratrol and multivitamin complex) in 33 patients with relapsing-remitting multiple sclerosis and 10 patients with primary-progressive multiple sclerosis. At 0/3/6 months, patients had neurological examination, filled questionnaires and underwent anthropometric measurements and biochemical analyses. Serum fatty acids and vitamin D levels were measured as markers of dietary compliance and nutritional efficacy of treatment, whereas serum gelatinase levels were analyzed as markers of inflammatory status. All patients had insufficient levels of vitamin D at baseline, but their values did not ameliorate following a weekly administration of 5000  IU, and rather decreased over time. Conversely, omega-3 polyunsaturated fatty acids increased already after three months, even under dietary restriction only. Co-treatment with interferon-beta in relapsing-remitting multiple sclerosis was irrelevant to vitamin D levels. After six months nutritional treatment, no significant changes in neurological signs were observed in any group. However, serum levels of the activated isoforms of gelatinase matrix metalloproteinase-9 decreased by 59% in primary-progressive multiple sclerosis and by 51% in relapsing-remitting multiple sclerosis patients under nutritional intervention, including dietary supplements. This study indicates that a healthy nutritional intervention is well accepted by people with multiple sclerosis and may ameliorate their physical and inflammatory status. PMID:26785711

  9. Anti-inflammatory nutritional intervention in patients with relapsing-remitting and primary-progressive multiple sclerosis: A pilot study.

    PubMed

    Riccio, Paolo; Rossano, Rocco; Larocca, Marilena; Trotta, Vincenzo; Mennella, Ilario; Vitaglione, Paola; Ettorre, Michele; Graverini, Antonio; De Santis, Alessandro; Di Monte, Elisabetta; Coniglio, Maria Gabriella

    2016-03-01

    The aim of this work was to assess the influence of nutritional intervention on inflammatory status and wellness in people with multiple sclerosis. To this end, in a seven-month pilot study we investigated the effects of a calorie-restricted, semi-vegetarian diet and administration of vitamin D and other dietary supplements (fish oil, lipoic acid, omega-3 polyunsaturated fatty acids, resveratrol and multivitamin complex) in 33 patients with relapsing-remitting multiple sclerosis and 10 patients with primary-progressive multiple sclerosis. At 0/3/6 months, patients had neurological examination, filled questionnaires and underwent anthropometric measurements and biochemical analyses. Serum fatty acids and vitamin D levels were measured as markers of dietary compliance and nutritional efficacy of treatment, whereas serum gelatinase levels were analyzed as markers of inflammatory status. All patients had insufficient levels of vitamin D at baseline, but their values did not ameliorate following a weekly administration of 5000  IU, and rather decreased over time. Conversely, omega-3 polyunsaturated fatty acids increased already after three months, even under dietary restriction only. Co-treatment with interferon-beta in relapsing-remitting multiple sclerosis was irrelevant to vitamin D levels. After six months nutritional treatment, no significant changes in neurological signs were observed in any group. However, serum levels of the activated isoforms of gelatinase matrix metalloproteinase-9 decreased by 59% in primary-progressive multiple sclerosis and by 51% in relapsing-remitting multiple sclerosis patients under nutritional intervention, including dietary supplements. This study indicates that a healthy nutritional intervention is well accepted by people with multiple sclerosis and may ameliorate their physical and inflammatory status. © 2016 by the Society for Experimental Biology and Medicine.

  10. Effect of special Hungarian probiotic kefir on faecal microflora

    PubMed Central

    Figler, Mária; Mózsik, Gyula; Schaffer, Béla; Gasztonyi, Beáta; Ács, Pongrác; Szili, Béla; Rab, Regina; Szakály, Sándor

    2006-01-01

    AIM: To investigate the effect of a four-week consumption of a special Hungarian probiotic agent (Biofir®) on the faecal microflora in human healthy subjects. METHODS: The effect of Biofir® with 106/cm3 initial germs on the faecal microflora was studied in 120 healthy volunteers (71 females, 49 males). The traditional Russian type kefir was used as control. The various germ groups and pH values were determined in wk 2, 4 and 6. RESULTS: The number of all microbes increased during the 4-week probiotic treatment. The number of microbes increased 4.3-fold in the control group and 6.8-fold in Biofir-treated group. The probiotic kefir caused multiplication of the probiotic flora, meanwhile the undesired bacteria multiplied in the control group. No significant change of pH values of the faeces was found in both groups. CONCLUSION: The Hungarian probiotic kefir (Biofir®) is capable of promoting multiplication of probiotic bacterial flora in the large bowel. PMID:16534858

  11. [The influence of high-tone power therapy on the functional status of patients with multiple sclerosis].

    PubMed

    Kubsik, Anna; Klimkiewicz, Paulina; Klimkiewicz, Robert; Jankowska, Katarzyna; Jankowska, Agnieszka; Woldańska-Okońska, Marta

    2014-07-01

    Multiple sclerosis is a chronic, inflammatory, demyelinating disease of the central nervous system, which is characterized by diverse symptomatology. Most often affects people at a young age gradually leading to their disability. Looking for new therapies to alleviate neurological deficits caused by the disease. One of the alternative methods of therapy is high - tone power therapy. The article is a comparison of high-tone power therapy and kinesis in improving patients with multiple sclerosis. The aim of this study was to evaluate the effectiveness of high-tone power therapy and exercises in kinesis on the functional status of patients with multiple sclerosis. The study involved 20 patients with multiple sclerosis, both sexes, treated at the Department of Rehabilitation and Physical Medicine in Lodz. Patients were randomly divided into two groups studied. In group high-tone power therapy applied for 60 minutes, while in group II were used exercises for kinesis. Treatment time for both groups of patients was 15 days. To assess the functional status scale was used: Expanded Disability Status Scale of Kurtzke (EDSS), as well as by Barthel ADL Index. Assessment of quality of life were made using MSQOL Questionnaire-54. For the evaluation of gait and balance using Tinetti scale, and pain VAS rated, and Laitinen. Changes in muscle tone was assessed on the basis of the Ashworth scale. Both group I and II improved on scales conducted before and after therapy. In group I, in which the applied high-tone power therapy, reported statistically significant results in 9 out of 10 tested parameters, while in group II, which was used in the exercises in kinesis an improvement in 6 out of 10 tested parameters. Correlating the results of both the test groups in relation to each other did not show statistically significant differences. High-Tone Power Therapy beneficial effect on the functional status of patients with multiple sclerosis. Obtaining results in terms of number of tested parameters allows for the use of this therapy in the comprehensive improvement of patients with multiple sclerosis. Exercises from the scheme kinesis favorable impact on the functional status of patients with MS and are essential in the rehabilitation of these patients. In any group, no adverse effects were observed.

  12. Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM): a practical guide to management.

    PubMed

    Maciocia, Nicola; Wechalekar, Ashutosh; Yong, Kwee

    2017-12-01

    Monoclonal gammopathy of undetermined significance and smoldering multiple myeloma are precursor conditions of symptomatic multiple myeloma (MM). Diagnostic principles are aimed at excluding MM requiring therapy, other conditions associated with paraproteins that may require different management, and risk stratifying patients for the purposes of tailored follow-up and investigation. The International Myeloma Working Group have recently published a revised definition of MM, which singles out a small group of patients with smoldering multiple myeloma who are at very high risk of progression and organ damage; such patients are now included under the definition of MM and recommended to start anti-myeloma treatment. Furthermore, the recently published National Institute of Health and Care Excellence guideline recommends cross-sectional imaging techniques in place of skeletal survey. These recent recommendations are discussed, and practical guidance for investigation and management are presented. Copyright © 2016 John Wiley & Sons, Ltd.

  13. Effect of arthrocentesis plus platelet-rich plasma and platelet-rich plasma alone in the treatment of temporomandibular joint osteoarthritis: A retrospective matched cohort study (A STROBE-compliant article).

    PubMed

    Lin, Shang-Lun; Tsai, Chiang-Chin; Wu, Shang-Liang; Ko, Shun-Yao; Chiang, Wei-Fan; Yang, Jung Wu

    2018-04-01

    Although the research on using platelet-rich plasma (PRP) for temporomandibular joint osteoarthritis (TMJ-OA) has advanced, no unified standards exist for determining the joint use of arthrocentesis and the injection dose and frequency of PRP. This study aimed to compare the efficacy of 2 TMJ-OA treatment approaches, arthrocentesis plus platelet-rich plasma (A+PRP) and PRP alone, and attempted to provide another potential treatment option with a single injection of 2 mL of high-concentration and high-purity PRP.This retrospective matched cohort study enrolled 208 patients who were treated for temporomandibular disorders (TMDs) in the Department of Oral and Maxillofacial Surgery of Tainan Sin-Lau Hospital between August of 2013 and January of 2016, from which 90 patients were selected for the final analysis. The predictor variables were treatment outcome indicators, including joint crepitus sounds, TMD-associated headache, jaw range of motion <6 mm, myofascial pain with referral, temporomandibular joint (TMJ) arthralgia, pain when chewing most foods, and maximum assisted opening (MAO). The data were analyzed using χ tests, t tests, and multiple regression analyses.Among the 90 patients, 30 were assigned into the A+PRP group, and 60 were included in the PRP group. A matching method was used to ensure no statistically significant differences in the categorical and continuous variables between the 2 groups. After treatment, both the A+PRP and PRP groups showed improvements in TMJ-OA. The 2 treatment groups did not show statistically significant differences in the symptom improvement rates of joint crepitus sounds, reparative remodeling, and TMJ arthralgia. However, compared with PRP alone, the A+PRP treatment demonstrated superior performance in improving TMD-associated headache, jaw range of motion <6 mm, myofascial pain with referral, and pain when chewing most foods.Both A+PRP and PRP treatments can effectively improve multiple symptoms of TMJ-OA. Based on the results from this study, we recommend a single injection with 2 mL of high-concentration and high-purity PRP for TMJ-OA treatment. For patients with TMJ-OA accompanied by other clinical symptoms, including TMD-associated headache, jaw range of motion <6 mm, myofascial pain with referral, and pain when chewing most foods, a treatment approach using arthrocentesis prior to a PRP injection can achieve a higher efficacy.

  14. Meta-analysis of five photodisinfection clinical trials for periodontitis

    NASA Astrophysics Data System (ADS)

    Andersen, Roger C.; Loebel, Nicolas G.; Andersen, Dane M.

    2009-06-01

    Photodynamic therapy(PDT) has been demonstrated to effectively kill human periopathogens in vitro. To evaluate the efficacy of PDT in vivo a series of clinical trials was carried out in multiple centers and populations. Clinical parameters including clinical attachment level, pocket probing depth and bleeding on probing were all evaluated. All groups received the standard of care, scaling and root planing, and the treatment group additionally received a single treatment of PDT. Of the total 309 patients and over 40,000 pockets treated in these 5 trials it was determined that photodynamic therapy provided a statistically significant improvement in clinical parameters over scaling and root planing alone.

  15. Comparison of posterior lumbar interbody fusion (PLIF) with autogenous bone chips and PLIF with cage for treatment of double-level isthmic spondylolisthesis.

    PubMed

    Song, Deyong; Chen, Zhong; Song, Dewei; Li, Zaixue

    2015-11-01

    Spondylolytic defects involving multiple vertebral levels are rare. It is reported that only 1.48% of patients with back pain were diagnosed with multi-level spondylolysis. The incidence of multiple-level spondylolisthesis is even rarer, so far there have been few reports of multi-level isthmic spondylolisthesis in the literature. The aim of this study is to evaluate clinical and radiological outcomes of two different fusion techniques for treatment of double-level isthmic spondylolisthesis. Fifty-four patients who were managed surgically for treatment of double-level symptomatic isthmic spondylolisthesis were included in this study. Between May 2004 and September 2012, 29 consecutive patients underwent posterior lumbar interbody fusion (PLIF) with autogenous bone chips (group I) at Foshan Hospital of Traditional Chinese Medicine, Guangdong, China. Between March 2005 and December 2013, 25 consecutive patients underwent PLIF with cage (group II) at Zhujiang Hospital of Southern Medical University, Guangdong, China. The mean follow-up periods were 27.2 and 26.8 months, respectively. The mean VAS scores of back and leg pain significantly decreased from 7.2 to 2.2 and 5.8 to 2.1 in the group I and from 7.0 to 1.9 and 6.1 to 1.8 in the group II, respectively. In the group I, mean ODI scores improved significantly from 54% to 14.2% and, in the group II, from 60% to 12.6%. In both groups, VAS and ODI scores significantly changed from pre- to postoperatively (p<0.001), but postoperative outcome between groups was statistically not significant. Solid union was observed in 27 of 29 patients (89.6%) in the group I and in 22 of 25 patients (88%) in the group II, without statistically significant differences (p>0.05). In both groups, changes in disc height, degree of listhesis, and whole lumbar lordosis between the pre- and postoperative periods were significant. Clinical and functional outcomes demonstrate no significant differences between groups in treating back and leg pain of adult patients with double-level isthmic spondylolisthesis. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Development of an evidence-based decision pathway for vestibular schwannoma treatment options.

    PubMed

    Linkov, Faina; Valappil, Benita; McAfee, Jacob; Goughnour, Sharon L; Hildrew, Douglas M; McCall, Andrew A; Linkov, Igor; Hirsch, Barry; Snyderman, Carl

    To integrate multiple sources of clinical information with patient feedback to build evidence-based decision support model to facilitate treatment selection for patients suffering from vestibular schwannomas (VS). This was a mixed methods study utilizing focus group and survey methodology to solicit feedback on factors important for making treatment decisions among patients. Two 90-minute focus groups were conducted by an experienced facilitator. Previously diagnosed VS patients were recruited by clinical investigators at the University of Pittsburgh Medical Center (UPMC). Classical content analysis was used for focus group data analysis. Providers were recruited from practices within the UPMC system and were surveyed using Delphi methods. This information can provide a basis for multi-criteria decision analysis (MCDA) framework to develop a treatment decision support system for patients with VS. Eight themes were derived from these data (focus group + surveys): doctor/health care system, side effects, effectiveness of treatment, anxiety, mortality, family/other people, quality of life, and post-operative symptoms. These data, as well as feedback from physicians were utilized in building a multi-criteria decision model. The study illustrated steps involved in the development of a decision support model that integrates evidence-based data and patient values to select treatment alternatives. Studies focusing on the actual development of the decision support technology for this group of patients are needed, as decisions are highly multifactorial. Such tools have the potential to improve decision making for complex medical problems with alternate treatment pathways. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. The Impact of Psycho-Education on in Vitro Fertilisation Treatment Efficiency.

    PubMed

    Belevska, Jana

    2015-01-01

    The aim of the study was to examine the efficiency of psycho-education of candidates for the IVF in stress, anxiety and depression decreasing, and the impact of the psycho educative techniques on the successfulness of the treatment. A random sample of 64 candidates for IVF treatment is divided in two groups: control group without psycho-education (32 candidates) and intervention group of 32 candidates included in psycho-education. Depression, anxiety and stress scale (DASS) was used as a psychometric test. It's a multiple choice, self-reported inventory for measuring the levels of stress, anxiety and severity of depression. For statistic evaluation SPSS software was used. The study shows that the intervention group included in psycho-education has a signifycantly lower scores on stress (t = 3.201, p < 0.05) and anxiety (t = 2.311, p < 0.05). The scale of depression did not show differences in the two compared groups. However, the success of the IVF treatment is more common among candidates that were included in psycho-education. In our country, psycho-education of candidates for in vitro fertilization is not systematically integrated in the treatment. The study showed the efficiency of psycho-education in anxiety and stress decreasing, as well as significant impact in the successfulness of the treatment. It was pointed out that psychological support of candidates for IVF is important for the lessening of the negative emotional reactions of candidates as well as for the successfulness of the treatment.

  18. Treating alcoholism as a chronic disease: approaches to long-term continuing care.

    PubMed

    McKay, James R; Hiller-Sturmhofel, Susanne

    2011-01-01

    For many patients, alcohol and other drug (AOD) use disorders are chronic, recurring conditions involving multiple cycles of treatment, abstinence, and relapse. To disrupt this cycle, treatment can include continuing care to reduce the risk of relapse. The most commonly used treatment approach is initial intensive inpatient or outpatient care based on 12-step principles, followed by continuing care involving self-help groups, 12-step group counseling, or individual therapy. Although these programs can be effective, many patients drop out of initial treatment or do not complete continuing care. Thus, researchers and clinicians have begun to develop alternative approaches to enhance treatment retention in both initial and continuing care. One focus of these efforts has been the design of extended treatment models. These approaches increasingly blur the distinction between initial and continuing care and aim to prolong treatment participation by providing a continuum of care. Other researchers have focused on developing alternative treatment strategies (e.g., telephone-based interventions) that go beyond traditional settings and adaptive treatment algorithms that may improve outcomes for clients who do not respond well to traditional approaches.

  19. A task-oriented circuit training in multiple sclerosis: a feasibility study

    PubMed Central

    2014-01-01

    Background The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training (TOCT) in a sample of multiple sclerosis (MS) subjects on walking competency, mobility, fatigue and health-related quality of life (HRQoL). Methods 24 MS subjects (EDSS 4.89 ± 0.54, 17 female and 7 male, 52.58 ± 11.21 years, MS duration 15.21 ± 8.68 years) have been enrolled and randomly assigned to 2 treatment groups: (i) experimental group received 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group did not receive any specific rehabilitation intervention. A feasibility patient-reported questionnaire was administered after TOCT. Functional outcome measures were: walking endurance (Six Minute Walk Test), gait speed (10 Meter Walk Test), mobility (Timed Up and Go test) and balance (Dynamic Gait Index). Furthermore, self-reported questionnaire of motor fatigue (Fatigue Severity Scale), walking ability (Multiple Sclerosis Walking Scale – 12) and health-related quality of life (Multiple Sclerosis Impact Scale – 29) were included. Subjects’ assessments were delivered at baseline (T0), after TOCT (T1) and 3 months of home-based exercise program (T2). Results After TOCT subjects reported a positive global rating on the received treatment. At 3 months, we found a 58.33% of adherence to the home-exercise program. After TOCT, walking ability and health-related quality of life were improved (p < 0.05) with minor retention after 3 months. The control group showed no significant changes in any variables. Conclusions This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments; moreover it might improve walking abilities. Trial registration NCT01464749 PMID:24906545

  20. Effectiveness of massage therapy as co-adjuvant treatment to exercise in osteoarthritis of the knee: a randomized control trial.

    PubMed

    Cortés Godoy, Virginia; Gallego Izquierdo, Tomás; Lázaro Navas, Irene; Pecos Martín, Daniel

    2014-01-01

    The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee (KOA) is widely evidenced. The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA. A blind, randomized controlled trial design was used. Eighteen women were randomly allocated to two different groups. Group A was treated with massage therapy and an exercise program, and Group B was treated with the exercise program alone. The intervention lasted for 6 weeks. Outcomes were assessed using a verbal analogue scale (VAS), the WOMAC index, and the Get-Up and Go test. Baseline, post-treatment, and 1- and 3- month follow-up data were collected. Values were considered statistically significant at a p < 0.05. The Mann-Whitney U test was applied in order to find out the differences between groups, and to verify the existence of such differences, the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out. In both groups, significant differences were found in the three variables between the baseline measurement and three months after treatment, with the exception of the WOMAC variable in group B (p=0.064) No significant differences were found between both groups in the WOMAC index (p=0.508) and VAS (p=0.964) variables and the Get-Up and Go test (p=0.691). Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA. The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects.

  1. Experience of Orthodontic Treatment and Symptoms of Temporomandibular Joint in South Korean Adults.

    PubMed

    Hwang, Sang-Hee; Park, Shin-Goo

    2018-01-01

    No epidemiological studies have targeted the association between experience of orthodontic treatment and symptoms of temporomandibular joint (TMJ) in a large adult population. In this study, we investigated whether experience of orthodontic treatment is associated with symptoms of TMJ in adults. We used data from the Fifth Korea National Health and Nutrition Examination Survey (KNHANES V), conducted in 2011. Trained dentists asked subjects to report their experience of orthodontic treatment and symptoms of TMJ. Overall, 5936 subjects aged over 19 yr were included in this study (2528 males). The data were analyzed using the chi-square test and multiple logistic regression tests. The group with experience of orthodontic treatment had more symptoms of TMJ than the group without orthodontic experience. After adjusting for all covariates (i.e., age, sex, marital status, income, education, stress, teeth injury, and occupation), the adjusted odds ratio was 2.53 (95%CI 1.74-3.67). Experience of orthodontic treatment could be related to increased symptoms of TMJ.

  2. Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change.

    PubMed

    Prochaska, Judith J; Fromont, Sebastien C; Delucchi, Kevin; Young-Wolff, Kelly C; Benowitz, Neal L; Hall, Stephen; Bonas, Thomas; Hall, Sharon M

    2014-12-01

    Individuals with serious mental illness (SMI) are dying on average 25 years prematurely. The leading causes are chronic preventable diseases. In the context of a tobacco-treatment trial, this exploratory study examined the behavioral risk profiles of adults with SMI to identify broader interventional needs. Recruited from five acute inpatient psychiatry units, participants were 693 adult smokers (recruitment rate = 76%, 50% male, 45% Caucasian, age M = 39, 49% had income < $10,000) diagnosed with mood disorders (71%), substance-use disorders (63%), posttraumatic stress disorder (39%), psychotic disorders (25%), and attention deficit-hyperactivity disorder (25%). The Staging Health Risk Assessment, the primary measure used in this study, screened for risk status and readiness to change 11 health behaviors, referencing the period prior to acute hospitalization. Participants averaged 5.2 (SD = 2.1) risk behaviors, including smoking (100%), high-fat diet (68%), inadequate fruits/vegetables (67%), poor sleep (53%), physical inactivity (52%), and marijuana use (46%). The percent prepared to change ranged from 23% for tobacco and marijuana to 76% for depression management. Latent class analysis differentiated three risk groups: the global higher risk group included patients elevated on all risk behaviors; the global lower risk group was low on all risks; and a mood and metabolic risk group, characterized by inactivity, unhealthy diet, sleep problems, and poor stress and depression management. The global higher risk group (11% of sample) was younger, largely male, and had the greatest number of risk behaviors and mental health diagnoses; had the most severe psychopathologies, addiction-treatment histories, and nicotine dependence; and the lowest confidence for quitting smoking and commitment to abstinence. Most smokers with SMI engaged in multiple risks. Expanding targets to treat co-occurring risks and personalizing treatment to individuals' multibehavioral profiles may increase intervention relevance, interest, and impact on health.

  3. Combined treatment with corticosteroids and moclobemide favors normalization of hypothalamo-pituitary-adrenal axis dysregulation in relapsing-remitting multiple sclerosis: a randomized, double blind trial.

    PubMed

    Then Bergh, F; Kümpfel, T; Grasser, A; Rupprecht, R; Holsboer, F; Trenkwalder, C

    2001-04-01

    Hyperresponsiveness of the hypothalamo-pituitary-adrenal (HPA) axis in multiple sclerosis (MS), an autoimmune inflammatory disease of the central nervous system, is presumably due to diminished corticosteroid receptor function. It probably influences the immune response, but its clinical significance is not clear. Similar HPA dysregulation occurs in depression and is reversible with successful antidepressant treatment. We conducted a double blind, placebo-controlled trial to evaluate the neuroendocrine effect of cotreatment with the antidepressant moclobemide as an adjunct to oral corticosteroids in MS. Twenty-one patients with definite relapsing-remitting MS (11 females, aged 33.9 +/- 2.0 yr; Expanded Disability Status Scale score of neurological impairment, 2.0--6.5) in acute relapse were treated with placebo (n = 13) or 300 mg moclobemide (reversible monoamine oxidase A inhibitor; n = 8) for 75 days. All received oral fluocortolone from day 7 on, and the dose was tapered until day 29. Effects were evaluated using the combined dexamethasone-CRH test and clinically on days 1, 30, and 75. At baseline, the HPA axis was mildly activated, comparably for treatment groups [area under the curve for cortisol (AUC-Cort), 213.8 +/- 76.8 arbitrary units in the moclobemide group vs. 225.8 +/- 65.1 in the steroid alone group; mean +/- SEM]. In a group of healthy controls with comparable demographic characteristics, the AUC-Cort was 107.4 +/- 14.1. Moclobemide cotreatment resulted in normalization of the HPA axis response, whereas the HPA system hyperresponse was maintained with steroids alone (AUC-Cort on day 30, 85.9 +/- 22.8 vs.177.1 +/- 68.5; on day 75, 111.0 +/- 46.0 vs. 199.2 +/- 64.6). The change in Expanded Disability Status Scale was comparable for both groups. Although corticosteroids alone had no effect on the HPA response using the dexamethasone-CRH test, treatment with moclobemide combined with corticosteroids favors normalization of the HPA response in relapsing-remitting MS.

  4. Group training in interpersonal problem-solving skills for workplace adaptation of adolescents and adults with Asperger syndrome: a preliminary study.

    PubMed

    Bonete, Saray; Calero, María Dolores; Fernández-Parra, Antonio

    2015-05-01

    Adults with Asperger syndrome show persistent difficulties in social situations which psychosocial treatments may address. Despite the multiple studies focusing on social skills interventions, only some have focused specifically on problem-solving skills and have not targeted workplace adaptation training in the adult population. This study describes preliminary data from a group format manual-based intervention, the Interpersonal Problem-Solving for Workplace Adaptation Programme, aimed at improving the cognitive and metacognitive process of social problem-solving skills focusing on typical social situations in the workplace based on mediation as the main strategy. A total of 50 adults with Asperger syndrome received the programme and were compared with a control group of typical development. The feasibility and effectiveness of the treatment were explored. Participants were assessed at pre-treatment and post-treatment on a task of social problem-solving skills and two secondary measures of socialisation and work profile using self- and caregiver-report. Using a variety of methods, the results showed that scores were significantly higher at post-treatment in the social problem-solving task and socialisation skills based on reports by parents. Differences in comparison to the control group had decreased after treatment. The treatment was acceptable to families and subject adherence was high. The Interpersonal Problem-Solving for Workplace Adaptation Programme appears to be a feasible training programme. © The Author(s) 2014.

  5. Cognitive behavioral treatment groups for people with chronic depression in Hong Kong: a randomized wait-list control design.

    PubMed

    Wong, Daniel Fu Keung

    2008-01-01

    This study examined the effectiveness of a cognitive-behavioral treatment (CBT) group for Chinese people with depression in Hong Kong. Ninety-six subjects with depression were randomly assigned to CBT and control groups. After 10 weeks of treatment, participants in the CBT group had significantly fewer symptoms of depression, dysfunctional rules, and negative emotions, and significantly more adaptive coping skills when compared to the participants in the control group. Effect size statistics showed medium to large differences in symptoms of depression, coping skills, dysfunctional rules, and assumptions and negative emotions between the participants of the two groups (Cohen's d, between 0.50 and 0.88, except for positive emotions). Forty percent of the participants in the experimental group achieved a clinically significant level [reliable change index (RC)>1.96] of improvement. Lastly, the results of a multiple regression analysis provided some evidence of a linkage between cognition and depression among the participants in the experimental group. The design and content of the CBT groups, which aimed at facilitating the understanding and modification of automatic thoughts and dysfunctional rules, and of negative and positive coping skills among the participants, might have contributed to the initial positive results. (c) 2007 Wiley-Liss, Inc.

  6. Idiopathic Hypersomnia: A Study of 77 Cases

    PubMed Central

    Anderson, Kirstie N.; Pilsworth, Samantha; Sharples, Linda D.; Smith, Ian E.; Shneerson, John M.

    2007-01-01

    Study Objectives: To review the clinical and polysomnographic characteristics of idiopathic hypersomnia as well as the long-term response to treatment. Setting: The Respiratory Support and Sleep Centre at Papworth Hospital, Cambridge, UK. Patients and Design: A large database of more than 6000 patients with sleep disorders was reviewed. A retrospective study of the clinical and polysomnographic characteristics of 77 patients with idiopathic hypersomnia was performed. Comparison with a similar group of patients with narcolepsy was performed. The response to drug treatment was assessed in 61 patients over a mean follow-up of 3.8 years. Measurements and Results: Idiopathic hypersomnia was 60% as prevalent as narcolepsy. Comparison with a similar group of patients with narcolepsy showed that those with idiopathic hypersomnia were more likely to have prolonged unrefreshing daytime naps, a positive family history, increased slow-wave sleep, and a longer sleep latency on the Multiple Sleep Latency Test. The results of the Multiple Sleep Latency Test were not helpful in predicting disease severity or treatment response. The clinical features were heterogeneous and of variable severity. The majority of patients with idiopathic hypersomnia had symptoms that remained stable over many years, but 11% had spontaneous remission, which was never seen in narcolepsy. Two thirds of patients with idiopathic hypersomnolence had a sustained improvement in daytime somnolence with medication, although a third needed high doses or combinations of drugs. Conclusions: Idiopathic hypersomnolence has characteristic clinical and polysomnographic features but the prolonged latency on the Multiple Sleep Latency Test raises doubt about the validity of this test within the current diagnostic criteria. The disease often responds well to treatment and a substantial minority of patients appear to spontaneously improve. Citation: Anderson KN; Pilsworth S; Sharples LD; Smith IE; Shneerson JM. Idiopathic hypersomnia: a study of 77 cases. SLEEP 2007;30(10):1274-1281. PMID:17969461

  7. The Singapore Myeloma Study Group Consensus Guidelines for the management of patients with multiple myeloma

    PubMed Central

    de Mel, Sanjay; Chen, Yunxin; Gopalakrishnan, Sathish Kumar; Ooi, Melissa; Teo, Constance; Tan, Daryl; Teo, Min Li Claire; Tso, Allison CY; Lee, Lian King; Nagarajan, Chandramouli; Goh, Yeow Tee; Chng, Wee Joo

    2017-01-01

    Multiple myeloma (MM) is an incurable plasma cell neoplasm with an incidence of 100 patients per year in Singapore. Major advances have been made in the diagnosis, risk stratification and treatment of MM in the recent past. The reclassification of a subset of patients with smouldering MM, based on high-risk biomarkers, and the development of the revised international staging system are among the key new developments in diagnosis and staging. The use of novel agent-based treatment has resulted in significant improvements in the survival and quality of life of many patients with MM. Determining the optimal use of proteasome inhibitors, immunomodulators and, more recently, monoclonal antibodies is an area of ongoing investigation. In this guideline, we aim to provide an overview of the management of MM, incorporating the latest developments in diagnosis and treatment. PMID:27609508

  8. Heterogeneity-based, multiple mechanisms in the resistance to osimertinib (AZD9291): A case report.

    PubMed

    Liu, Yutao; Hao, Xuezhi; Hu, Xingsheng; Li, Junling; Wang, Yan; Wang, Hongyu; Xing, Puyuan; Li, Weihua; Ying, Jianming; Han, Xiaohong; Shi, Yuankai

    2018-04-01

    Osimertinib is a novel, irreversible, mutant-selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR mutations and the EGFR T790 mutation. Here, we report a woman with EGFR-mutated lung adenocarcinoma who, after 23-month treatment with gefitinib, developed the EGFR T790M mutation, which converted the T790M status from positive to negative before osimertinib treatment and developed MET amplification, leading to rapid progression on osimertinib in two months. Subsequent treatment with crizotinib and c-Met inhibitor plus gefitinib also failed to improve the clinical outcome, suggesting the potential existence of another resistance mechanism. Our findings revealed the underlying multiple and heterogeneous mechanisms in resistance to osimertinib, suggesting combination strategies should be considered post-osimertinib progression. © 2018 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

  9. The Singapore Myeloma Study Group Consensus Guidelines for the management of patients with multiple myeloma.

    PubMed

    de Mel, Sanjay; Chen, Yunxin; Gopalakrishnan, Sathish Kumar; Ooi, Melissa; Teo, Constance; Tan, Daryl; Teo, Min Li Claire; Tso, Allison Cy; Lee, Lian King; Nagarajan, Chandramouli; Goh, Yeow Tee; Chng, Wee Joo

    2017-02-01

    Multiple myeloma (MM) is an incurable plasma cell neoplasm with an incidence of 100 patients per year in Singapore. Major advances have been made in the diagnosis, risk stratification and treatment of MM in the recent past. The reclassification of a subset of patients with smouldering MM, based on high-risk biomarkers, and the development of the revised international staging system are among the key new developments in diagnosis and staging. The use of novel agent-based treatment has resulted in significant improvements in the survival and quality of life of many patients with MM. Determining the optimal use of proteasome inhibitors, immunomodulators and, more recently, monoclonal antibodies is an area of ongoing investigation. In this guideline, we aim to provide an overview of the management of MM, incorporating the latest developments in diagnosis and treatment. Copyright: © Singapore Medical Association.

  10. The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis.

    PubMed

    Ball, Susan; Vickery, Jane; Hobart, Jeremy; Wright, Dave; Green, Colin; Shearer, James; Nunn, Andrew; Cano, Mayam Gomez; MacManus, David; Miller, David; Mallik, Shahrukh; Zajicek, John

    2015-02-01

    The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial aimed to determine whether or not oral Δ(9)-tetrahydrocannabinol (Δ(9)-THC) slowed the course of progressive multiple sclerosis (MS); evaluate safety of cannabinoid administration; and, improve methods for testing treatments in progressive MS. There were three objectives in the CUPID study: (1) to evaluate whether or not Δ(9)-THC could slow the course of progressive MS; (2) to assess the long-term safety of Δ(9)-THC; and (3) to explore newer ways of conducting clinical trials in progressive MS. The CUPID trial was a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. Patients were randomised in a 2 : 1 ratio to Δ(9)-THC or placebo. Randomisation was balanced according to Expanded Disability Status Scale (EDSS) score, study site and disease type. Analyses were by intention to treat, following a pre-specified statistical analysis plan. A cranial magnetic resonance imaging (MRI) substudy, Rasch measurement theory (RMT) analyses and an economic evaluation were undertaken. Twenty-seven UK sites. Adults aged 18-65 years with primary or secondary progressive MS, 1-year evidence of disease progression and baseline EDSS 4.0-6.5. Oral Δ(9)-THC (maximum 28 mg/day) or matching placebo. Three and 6 months, and then 6-monthly up to 36 or 42 months. Primary outcomes were time to EDSS progression, and change in Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) 20-point physical subscale (MSIS-29phys) score. Various secondary patient- and clinician-reported outcomes and MRI outcomes were assessed. RMT analyses examined performance of MS-specific rating scales as measurement instruments and tested for a symptomatic or disease-modifying treatment effect. Economic evaluation estimated mean incremental costs and quality-adjusted life-years (QALYs). Effectiveness - recruitment targets were achieved. Of the 498 randomised patients (332 to active and 166 to placebo), 493 (329 active and 164 placebo) were analysed. no significant treatment effect; hazard ratio EDSS score progression (active : placebo) 0.92 [95% confidence interval (CI) 0.68 to 1.23]; and estimated between-group difference in MSIS-29phys score (active-placebo) -0.9 points (95% CI -2.0 to 0.2 points). Secondary clinical and MRI outcomes: no significant treatment effects. Safety - at least one serious adverse event: 35% and 28% of active and placebo patients, respectively. RMT analyses - scale evaluation: MSIS-29 version 2, MS Walking Scale-12 version 2 and MS Spasticity Scale-88 were robust measurement instruments. There was no clear symptomatic or disease-modifying treatment effect. Economic evaluation - estimated mean incremental cost to NHS over usual care, over 3 years £27,443.20 per patient. No between-group difference in QALYs. The CUPID trial failed to demonstrate a significant treatment effect in primary or secondary outcomes. There were no major safety concerns, but unwanted side effects seemed to affect compliance. Participants were more disabled than in previous studies and deteriorated less than expected, possibly reducing our ability to detect treatment effects. RMT analyses supported performance of MS-specific rating scales as measures, enabled group- and individual person-level examination of treatment effects, but did not influence study inferences. The intervention had significant additional costs with no improvement in health outcomes; therefore, it was dominated by usual care and not cost-effective. Future work should focus on determining further factors to predict clinical deterioration, to inform the development of new studies, and modifying treatments in order to minimise side effects and improve study compliance. The absence of disease-modifying treatments in progressive MS warrants further studies of the cannabinoid pathway in potential neuroprotection. Current Controlled Trials ISRCTN62942668. The National Institute for Health Research Health Technology Assessment programme, the Medical Research Council Efficacy and Mechanism Evaluation programme, Multiple Sclerosis Society and Multiple Sclerosis Trust. The report will be published in full in Health Technology Assessment; Vol. 19, No. 12. See the NIHR Journals Library website for further project information.

  11. Control Group Paradigms in Studies Investigating Acute Effects of Exercise on Cognitive Performance-An Experiment on Expectation-Driven Placebo Effects.

    PubMed

    Oberste, Max; Hartig, Philipp; Bloch, Wilhelm; Elsner, Benjamin; Predel, Hans-Georg; Ernst, Bernhard; Zimmer, Philipp

    2017-01-01

    Introduction: Many studies report improvements in cognitive performance following acute endurance exercise compared to control group treatment. These cognitive benefits are interpreted as a result of a physiological response to exercise. However, it was also hypothesized that expectation-driven placebo effects account for these positive effects. The purpose of this study was to investigate the differences between expectations for cognitive benefits toward acute endurance exercise and multiple control group treatments. Methods: Healthy individuals ( N = 247, 24.26 ± 3.88 years) were randomized to eight different groups watching videos of a moderate, a vigorous exercise treatment or one control group treatment (waiting, reading, video-watching, stretching, myofascial release workout, and very light exercise). Then, they were introduced to three commonly used cognitive test procedures in acute exercise-cognition research (Stroop-test, Trail-Making-test, Free-recall-task). Participants rated the effect they would expect on their performance in those tasks, if they had received the treatment shortly before the task, on an 11-point Likert scale. Results: No significantly different expectations for cognitive benefits toward acute moderate exercise and control group treatments could be revealed. Participants expected significantly worse performance following vigorous exercise compared to following waiting and stretching for all cognitive tests. Significantly worse performance after vigorous exercise compared to after very light exercise was expected for Stroop and Free-recall. For Free-recall, participants expected worse performance after vigorous exercise compared to myofascial release training as well. Conclusion: Our results indicate that expectation-driven placebo effects are unlikely to cause the reported greater cognitive improvements following acute moderate and vigorous endurance exercise compared to following common control group treatments.

  12. Control Group Paradigms in Studies Investigating Acute Effects of Exercise on Cognitive Performance–An Experiment on Expectation-Driven Placebo Effects

    PubMed Central

    Oberste, Max; Hartig, Philipp; Bloch, Wilhelm; Elsner, Benjamin; Predel, Hans-Georg; Ernst, Bernhard; Zimmer, Philipp

    2017-01-01

    Introduction: Many studies report improvements in cognitive performance following acute endurance exercise compared to control group treatment. These cognitive benefits are interpreted as a result of a physiological response to exercise. However, it was also hypothesized that expectation-driven placebo effects account for these positive effects. The purpose of this study was to investigate the differences between expectations for cognitive benefits toward acute endurance exercise and multiple control group treatments. Methods: Healthy individuals (N = 247, 24.26 ± 3.88 years) were randomized to eight different groups watching videos of a moderate, a vigorous exercise treatment or one control group treatment (waiting, reading, video-watching, stretching, myofascial release workout, and very light exercise). Then, they were introduced to three commonly used cognitive test procedures in acute exercise-cognition research (Stroop-test, Trail-Making-test, Free-recall-task). Participants rated the effect they would expect on their performance in those tasks, if they had received the treatment shortly before the task, on an 11-point Likert scale. Results: No significantly different expectations for cognitive benefits toward acute moderate exercise and control group treatments could be revealed. Participants expected significantly worse performance following vigorous exercise compared to following waiting and stretching for all cognitive tests. Significantly worse performance after vigorous exercise compared to after very light exercise was expected for Stroop and Free-recall. For Free-recall, participants expected worse performance after vigorous exercise compared to myofascial release training as well. Conclusion: Our results indicate that expectation-driven placebo effects are unlikely to cause the reported greater cognitive improvements following acute moderate and vigorous endurance exercise compared to following common control group treatments. PMID:29276483

  13. The Results of the Combine Treatment of Patients with Liver Bilobar Metastases from Colorectal Cancer Using Radiofrequency Ablation.

    PubMed

    Kaganov, Oleg Igorevich; Kozlov, Sergei Vasilevich; Orlov, Andrei Evgenyevich; Blinov, Nikita Vyacheslavovich

    2018-06-01

    Colorectal cancer (CRC) is the third most common cancer worldwide. The mortality from CRC remains very high. The main cause of such a high mortality is a disseminate process with the appearance of distant metastases. In this regard, the treatment of metastatic lesions is recognized as an important trend in modern oncology. The program of study included 176 patients with colorectal cancer after primary tumor removal with the malignant progression-multiple (more than 4) bilobar liver metastases. The research was organized in Samara Regional Oncology Centre from 2001 to 2014. By the treatment method, patients were divided into two groups. Main group got the combined (chemotherapy + radiofrequency ablation (RFA)) treatment ( n  = 98). In control group, only chemotherapy was applied ( n  = 78). One-, two-, and three-year OS were 73.5, 25.1, and 7.2% in the main group and 39.6, 6.3, and 2.1% in the control group. The RFA application allowed us to reach the index of 4-year survival 1.8% in the main group, while we received only 2.1 of 3-year survival in the control group. The OS median reached 18 months in the main group and 11 months in the control group. So, the OS curves in two comparing groups were significantly different according to statistics (log-rank test 3.77, р  = 0.000). The application of RFA in combination with chemotherapy in the treatment of bilobar metastasis colorectal cancer allows to improve the performance of disease-free survival and overall survival significantly, compared with the group of patients who received only chemotherapy.

  14. Influence of atmospheric pressure low-temperature plasma treatment on the shear bond strength between zirconia and resin cement.

    PubMed

    Ito, Yuki; Okawa, Takahisa; Fukumoto, Takahiro; Tsurumi, Akiko; Tatsuta, Mitsuhiro; Fujii, Takamasa; Tanaka, Junko; Tanaka, Masahiro

    2016-10-01

    Zirconia exhibits excellent strength and high biocompatibility in technological applications and it is has therefore been investigated for clinical applications and research. Before setting prostheses, a crown prosthesis inner surface is sandblasted with alumina to remove contaminants and form small cavities. This alumina sandblasting causes stress-induced phase transition of zirconia. Atmospheric-pressure low-temperature plasma has been applied in the dental industry, particularly for adhesives, as a surface treatment to activate the surface energy and remove contaminants. The purpose of this study was to examine the influence of atmospheric-pressure low-temperature plasma treatment on the shear bond strength between zirconia and adhesive resin cement. The surface treatment method was classified into three groups: untreated (Cont group), alumina sandblast treatment (Sb group), and atmospheric-pressure low-temperature plasma treatment (Ps group). Adhesive resin cement was applied to stainless steel and bonded to zirconia. Shear adhesion tests were performed after complete hardening of the cement. Multiple comparisons were performed using a one-way analysis of variance and the Bonferroni method. X-ray diffractometry was used to examine the change in zirconia crystal structure. Statistically significant differences were noted between the control and Sb groups and between the control and Ps groups. In contrast, no statistically significant differences were noted for the Ps and Sb bond strength. Atmospheric-pressure low-temperature plasma treatment did not affect the zirconia crystal structure. Atmospheric-pressure low-temperature plasma treatment improves the bonding strength of adhesive resin cement as effectively as alumina sandblasting, and does not alter the zirconia crystal structure. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  15. The Interactive Effects of Computer Conferencing and Multiple Intelligences on Expository Writing.

    ERIC Educational Resources Information Center

    Cifuentes, Lauren; Hughey, Jane

    2003-01-01

    Investigates the differential effects of computer conferencing on expository writing for students of seven intelligence types. Students were assigned to treatment groups that provided controlled exposure to a topic: unstructured exposure; computer conferencing; face-to-face discussion; and computer conferencing and face-to-face discussion.…

  16. Sub-Lexical Reading Intervention in a Student with Dyslexia and Asperger's Disorder

    ERIC Educational Resources Information Center

    Wright, Craig; Conlon, Elizabeth; Wright, Michalle; Dyck, Murray

    2011-01-01

    Dyslexia is a common presenting condition in clinic and educational settings. Unlike the homogenous groups used in randomised trials, educators typically manage children who have multiple developmental problems. Investigations are required into how these complex cases respond to treatment identified as efficacious by controlled trials. This study…

  17. Utility of the PFA-100 instrument and the novel multiplate analyzer for the assessment of aspirin and clopidogrel effects on platelet function in patients with cardiovascular disease.

    PubMed

    Mueller, Thomas; Dieplinger, Benjamin; Poelz, Werner; Haltmayer, Meinhard

    2009-12-01

    This study evaluated the utility of the PFA-100 and the Multiplate analyzer for the assessment of aspirin and clopidogrel effects on platelet function in patients with cardiovascular disease. Platelet function was determined with the PFA-100 using collagen+epinephrine (CEPI) and collagen+adenosine-5'-diphosphate (CADP) cartridges, and with whole blood impedance aggregometry using the Multiplate ASPI and ADP+PG tests (aggregation triggered with arachidonic acid and ADP+ prostaglandin E1, respectively). Four study groups were identified from the 154 patients enrolled: patients without antiplatelet therapy, patients with 100 mg aspirin daily but without clopidogrel treatment, patients with 75 mg clopidogrel daily but without aspirin treatment, and patients with both 100 mg aspirin daily plus 75 mg clopidogrel daily. It was found that the PFA-100 instrument is useful for detection of aspirin but not for detection of a clopidogrel effect, while the Multiplate analyzer is useful for specific detection of both aspirin and clopidogrel effects on platelet function.

  18. Pilates exercise training vs. physical therapy for improving walking and balance in people with multiple sclerosis: a randomized controlled trial.

    PubMed

    Kalron, Alon; Rosenblum, Uri; Frid, Lior; Achiron, Anat

    2017-03-01

    Evaluate the effects of a Pilates exercise programme on walking and balance in people with multiple sclerosis and compare this exercise approach to conventional physical therapy sessions. Randomized controlled trial. Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Forty-five people with multiple sclerosis, 29 females, mean age (SD) was 43.2 (11.6) years; mean Expanded Disability Status Scale (S.D) was 4.3 (1.3). Participants received 12 weekly training sessions of either Pilates ( n=22) or standardized physical therapy ( n=23) in an outpatient basis. Spatio-temporal parameters of walking and posturography parameters during static stance. Functional tests included the Time Up and Go Test, 2 and 6-minute walk test, Functional Reach Test, Berg Balance Scale and the Four Square Step Test. In addition, the following self-report forms included the Multiple Sclerosis Walking Scale and Modified Fatigue Impact Scale. At the termination, both groups had significantly increased their walking speed ( P=0.021) and mean step length ( P=0.023). According to the 2-minute and 6-minute walking tests, both groups at the end of the intervention program had increased their walking speed. Mean (SD) increase in the Pilates and physical therapy groups were 39.1 (78.3) and 25.3 (67.2) meters, respectively. There was no effect of group X time in all instrumented and clinical balance and gait measures. Pilates is a possible treatment option for people with multiple sclerosis in order to improve their walking and balance capabilities. However, this approach does not have any significant advantage over standardized physical therapy.

  19. Endovascular treatment of thoracic disease: patient selection and a proposal of a risk score.

    PubMed

    Rodrigues Alves, Claudia Maria; da Fonseca, José Honório Palma; de Souza, José Augusto Marcondes; Camargo Carvalho, Antonio Carlos; Buffolo, Enio

    2002-04-01

    Although selection criteria and subgroup analysis are still in the early developmental stages, endovascular treatment of aortic disease has become an alternative to surgery for many patients. From November 1996 to November 1999, 49 patients were treated with a self-expandable endoprosthesis at our institution. Most patients had acute aortic dissections. Thirteen of these patients did not follow the anatomic selection protocol. We retrospectively analyzed these patients to compare our numerical risk score (which includes clinical and anatomic criteria) between groups with or without success and between groups that followed the anatomic protocol (P) or did not follow the anatomic protocol (E [exception]). Success rates were similar in groups P and E, although mortality rates were higher in group E. Patients from group E had longer procedures and required multiple stents more frequently. The proposed risk score was able to differentiate between groups with or without success, as well as between groups P and E. In order to reduce mortality and morbidity rates, careful selection criteria must be followed when treating patients endovascularly. Although it is time-consuming, using objective criteria can help select patients for endovascular treatment. We propose that patients with a risk score higher than 11 should only undergo percutaneous treatment when they have an unacceptably high surgical risk, and even so only after a detailed discussion of the risks.

  20. Application of laser radiation and magnetostimulation in therapy of patients with multiple sclerosis.

    PubMed

    Kubsik, Anna; Klimkiewicz, Robert; Janczewska, Katarzyna; Klimkiewicz, Paulina; Jankowska, Agnieszka; Woldańska-Okońska, Marta

    2016-01-01

    Multiple sclerosis is one of the most common neurological disorders. It is a chronic inflammatory demyelinating disease of the CNS, whose etiology is not fully understood. Application of new rehabilitation methods are essential to improve functional status. The material studied consisted of 120 patients of both sexes (82 women and 38 men) aged 21-81 years. The study involved patients with a diagnosis of multiple sclerosis. The aim of the study was to evaluate the effect of laser radiation and other therapies on the functional status of patients with multiple sclerosis. Patients were randomly divided into four treatment groups. The evaluation was performed three times - before the start of rehabilitation, immediately after rehabilitation (21 days of treatment) and subsequent control - 30 days after the patients leave the clinic. The following tests were performed for all patients to assess functional status: Expanded Disability Status Scale (EDSS) of Kurtzke and Barthel Index. Results of all testing procedures show that the treatment methods are improving the functional status of patients with multiple sclerosis, with the significant advantage of the synergistic action of laser and magneto stimulation. The combination of laser and magneto stimulation significantly confirmed beneficial effect on quality of life. The results of these studies present new scientific value and are improved compared to program of rehabilitation of patients with multiple sclerosis by laser radiation which was previously used. This study showed that synergic action of laser radiation and magneto stimulation has a beneficial effect on improving functional status, and thus improves the quality of life of patients with multiple sclerosis. The effects of all methods of rehabilitation are persisted after cessation of treatment applications, with a particular advantage of the synergistic action of laser radiation and magneto stimulation, which indicates the possibility to elicitation in these methods the phenomenon of the biological hysteresis.

  1. Efficacy of multiple micronutrient supplementation for improving anemia, micronutrient status, growth, and morbidity of Peruvian infants.

    PubMed

    López de Romaña, Guillermo; Cusirramos, Sandra; López de Romaña, Daniel; Gross, Rainer

    2005-03-01

    Anemia, micronutrient deficiencies, and growth faltering are still common in Peru. The study objective was to determine the efficacy of different micronutrient supplements in preventing growth failure, anemia, and micronutrient deficiencies in Peruvian infants. Three hundred and thirteen infants aged 6 to 12 mo participated in a double-blind, masked, controlled trial in which they were randomly assigned to receive either a daily dose of iron (DI), a daily dose of multiple micronutrients (DMM), a weekly dose of multiple micronutrients, or a placebo (P) for 6 mo. None of the supplements tested prevented growth faltering or the morbidities common during infancy. Anemia and plasma homocysteine concentrations fell significantly in all groups during the study, but the mean change of plasma homocysteine during the trial period was significantly smaller in the DI group than in other groups, and the increase in hemoglobin concentrations was smaller in the P group than the micronutrient treatment groups. Plasma ferritin concentrations decreased least in the groups taking daily micronutrient supplements containing iron (DI and DMM). There were no significant differences among groups in mean final values or changes in plasma zinc, retinol, tocopherol, or riboflavin. Although the DMM intervention was the most efficacious for preventing anemia, iron, and zinc deficiencies, 15%, 20%, and 50% of this group still remained anemic, zinc deficient, and iron deficient, respectively, at the end of the study. Further research thus should investigate whether higher doses of iron and zinc, together with infection control measures, are more efficacious.

  2. Chemotherapy in combination with cytokine-induced killer cell transfusion: An effective therapeutic option for patients with extensive stage small cell lung cancer.

    PubMed

    Huang, Jianmin; Kan, Quancheng; Lan; Zhao, Xuan; Zhang, Zhen; Yang, Shuangning; Li, Hong; Wang, Liping; Xu, Li; Cheng, Zhe; Zhang, Yi

    2017-05-01

    In the past decade of clinical studies, the combination of chemotherapy with cytokine induced killer (CIK) cell transfusion has confirmed a promised efficacy in several types of cancer. CIK cells are a mixture of T lymphocytes, generated from peripheral blood mononuclear cells induced by multiple cytokines. This study was aimed to evaluate the clinical efficacy of chemotherapy combined with CIK- cell therapy in patients with extensive stage small cell lung cancer (ES SCLC). Forty four patients with ES SCLC were enrolled in this study. All the patients received treatment from Oct 2010 to Sep 2013 in the First Affiliated Hospital of Zhengzhou University. Included patients were equally divided into 2 groups according to the treatment strategies. Patients in the combined treatment group received chemotherapy combined with CIK-cell transfusion and patients in the control group received chemotherapy alone. The short-term effects, overall survival (OS), progress free survival (PFS) and therapy-related adverse events were analyzed retrospectively. Short-term efficacy evaluation indicated that the total response rates in the combined treatment group and control group were 40.9% (9/22) and 9.1% (2/22), respectively. There was a significant difference between the two groups (p=0.0339). Furthermore, the PFS of the combined treatment group was significantly longer than that of the control group (8 vs. 4months, P=0.005). No severe side effect was observed after transfusion of CIK cells. These results indicated that chemotherapy combined with CIK-cell immunotherapy might provide a safe and effective treatment for patients with ES SCLC. Copyright © 2016. Published by Elsevier B.V.

  3. Multiple myeloma in the very elderly patient: challenges and solutions

    PubMed Central

    Willan, John; Eyre, Toby A; Sharpley, Faye; Watson, Caroline; King, Andrew J; Ramasamy, Karthik

    2016-01-01

    Diagnosis and management of myeloma in the very elderly patient is challenging. Treatment options have vastly improved for elderly myeloma patients but still require the clinician to personalize therapy. In this paper, we offer evidence-based, pragmatic advice on how to overcome six of the main challenges likely to arise: 1) diagnosis of myeloma in this age group, 2) assessment of the need for treatment, and the fitness for combination chemotherapy, 3) provision of the best quality of supportive care, 4) choice of combination chemotherapy in those fit enough for it, 5) treatment of relapsed myeloma, and 6) provision of end of life care. With an increased burden of comorbidities and a reduced resilience to treatment and its associated toxicities, the management of myeloma in this age group requires a different approach to that in younger patients to maximize both quality and length of life. PMID:27143866

  4. Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial.

    PubMed

    Rahn, Anne Christin; Köpke, Sascha; Kasper, Jürgen; Vettorazzi, Eik; Mühlhauser, Ingrid; Heesen, Christoph

    2015-03-21

    Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence. The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study. Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool. The primary outcome is 'informed choice' after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey). Secondary outcomes include decisional conflict, adherence to immunotherapy decisions, autonomy preference, planned behaviour, coping self-efficacy, and perceived involvement in coaching and decisional encounters. Safety outcomes are comprised of anxiety and depression and disease-specific quality of life. This trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany. Current Controlled Trials (identifier: ISRCTN37929939 ), May 27, 2014.

  5. Effect of Osteonecrosis Intervention Rod Versus Core Decompression Using Multiple Small Drill Holes on Early Stages of Necrosis of the Femoral Head: A Prospective Study on a Series of 60 Patients with a Minimum 1-Year-Follow-Up.

    PubMed

    Miao, Haixiong; Ye, Dongping; Liang, Weiguo; Yao, Yicun

    2015-01-01

    The conventional CD used 10 mm drill holes associated with a lack of structural support. Thus, alternative methods such as a tantalum implant, small drill holes, and biological treatment were developed to prevent deterioration of the joint. The treatment of CD by multiple 3.2 mm drill holes could reduce the femoral neck fracture and partial weight bearing was allowed. This study was aimed to evaluate the effect of osteonecrosis intervention rod versus core decompression using multiple small drill holes on early stages of necrosis of the femoral head. From January 2011 to January 2012, 60 patients undergoing surgery for osteonecrosis with core decompression were randomly assigned into 2 groups based on the type of core decompression used: (1) a total of 30 osteonecrosis patients (with 16 hips on Steinburg stageⅠ,20 hips on Steinburg stageⅡ) were treated with a porous tantalum rod insertion. The diameter of the drill hole for the intervention rod was 10mm.(2) a total of 30 osteonecrosis patients (with 14 hips on Steinburg stageⅠ,20 hips on Steinburg stageⅡ) were treated with core decompression using five drill holes on the lateral femur, the diameter of the hole was 3.2 mm. The average age of the patient was 32.6 years (20-45 years) and the average time of follow-up was 25.6 months (12- 28 months) in the rod implanted group. The average age of the patient was 35.2 years (22- 43 years) and the average time of follow-up was 26.3 months (12-28 months) in the small drill holes group. The average of surgical time was 40 min, and the mean volume of blood loss was 30 ml in both surgical groups. The average of Harris score was improved from 56.2 ± 7.1 preoperative to 80.2 ± 11.4 at the last follow-up in the rod implanted group (p < 0.05). The mean Harris score was improved from 53.8 ± 6.6 preoperative to 79.7 ± 13.2 at the last follow-up in the small drill holes group (p<0. 05). No significant difference was observed in Harris score between the two groups. At the last follow-up, 28 of 36 hips were at the same radiographic stages as pre-operation, and 8 deteriorated in the rod implanted group. 26 of 34 hips were at the same radiographic stage as pre-operation, and 8 deteriorated in the small drill holes group. No significant difference was observed in radiographic stage between the two groups. There was no favourable result on the outcome of a tantalum intervention implant compared to multiple small drill holes. CD via multiple small drill holes would allow similar postoperative load-bearing and seems to result in similar or even better clinical outcome without the prolonged implantation of an expensive tantalum implant. A tantalum rod intervention and core decompression using multiple small drill holes were effective on the stage I hips rather than stage II hips.

  6. Coenzyme Q10 as a treatment for fatigue and depression in multiple sclerosis patients: A double blind randomized clinical trial.

    PubMed

    Sanoobar, Meisam; Dehghan, Parvin; Khalili, Mohammad; Azimi, Amirreza; Seifar, Fatemeh

    2016-01-01

    Multiple sclerosis (MS) is the chronic inflammatory and demyelinating disorder of central nervous system which is accompanied with disability and negative life style changes such as fatigue and depression. The aim of this study is to investigate the effect of coenzyme Q10 (CoQ10) supplementation on fatigue and depression in patients with MS. We performed a randomized, double-blinded, placebo-controlled trial to determine the effect of CoQ10 supplement (500 mg/day) vs. placebo for 12 weeks. Fatigue symptoms were quantified by means of fatigue severity scale (FSS) and the Beck depression inventory (BDI) was used to assess depressive symptoms. A significant decrease of FSS was observed in CoQ10 group during the intervention (P = 0.001) and significant increase of FSS change was observed within placebo group (P = 0.001). Repeated measure analysis of variance showed a significant time-by-treatment interaction for FSS (baseline 41.5 ± 15.6 vs. endpoint 45 ± 13.6; F1,45 = 55.23, P < 0.001, η(2) = 0.56) and BDI (baseline 17.8 ± 12.2 vs. endpoint 20.4 ± 11.4; F1,45 = 40.3, P < 0.001, η(2) = 0.48), indicating significant decrease of FSS and BDI in CoQ10 group compared to placebo group. Our study suggests that CoQ10 supplementation (500 mg/day) can improve fatigue and depression in patients with multiple sclerosis.

  7. [State of the art treatment of progressive or refractory multiple myeloma].

    PubMed

    Schmidt-Wolf, I G H; Straka, C; Scheid, C; Einsele, H; Goldschmidt, H; Engelhardt, M

    2014-10-01

    Multiple myeloma (MM) is with an incidence of 4-6/100 000 inhabitants a fairly frequent malignancy of B cells. The incidence increases markedly with age. In this review changes in the treatment of relapsed / refractory myeloma during the last decade have been analysed. The present standard of care in the progressive or refractory myeloma was elaborated by the working group "Refractory Multiple Myeloma" using an extensive literature search for studies published between 2003 and 2013. Outside of clinical trials, high-dose therapy with stem cell transplantation is recommended in fit patients up to 75 years without significant comorbidities. Ongoing studies address the question about the least toxic and the most effective treatment. Therefore, inclusion of patients in therapeutic trials and use of novel agent combinations is highly recommended, e.g. with 3(rd) generation-IMIDs (pomalidomide), new proteasome inhibitors, such as carfilzomib, ixazomib or oprozomib, antibodies, such as elotuzumab, daratumumab or SAR650984, siltuximab, tabalumab, denosumab, romosozumab, BTK-, HSP-inhibitors and other innovative phase I/II agents. Based on new insights in the pathogenesis of the disease, treatment options for MM have changed significantly in recent years. There is a significantly larger treatment diversity, i.e. more MM-active agents and combinations are available today. Even with relapsed MM, patients with the disease often live longer and have fewer complications. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Effectiveness of monopolar dielectric transmission of pulsed electromagnetic fields for multiple sclerosis-related pain: A pilot study.

    PubMed

    Hochsprung, A; Escudero-Uribe, S; Ibáñez-Vera, A J; Izquierdo-Ayuso, G

    2018-05-08

    Pain is highly prevalent in patients with multiple sclerosis (MS); it is chronic in 50% of cases and is classified as nociceptive, neuropathic, or mixed-type. Pain affects quality of life, sleep, and the activities of daily living. Electrotherapy is an interesting alternative or complementary treatment in the management of pain in MS, with new innovations constantly appearing. This study evaluates the effectiveness of treatment with monopolar dielectric transmission of pulsed electromagnetic fields (PEMF) for pain associated with MS. We performed a randomised, placebo-controlled clinical trial including 24 patients, who were assessed with the Brief Pain Inventory, the Multiple Sclerosis International Quality of Life questionnaire, the Beck Depression Inventory, and the Modified Fatigue Impact Scale. Statistically significant improvements were observed in maximum and mean pain scores, as well as in the impact of pain on work, personal relationships, and sleep and rest. Not significant differences were found between the treatment and placebo groups. Treatment with PEMF may be effective in reducing pain in patients with MS, although further research is necessary to confirm its effectiveness over placebo and to differentiate which type of pain may be more susceptible to this treatment. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Tridimensional personality questionnaire: assessment in patients with social phobia and a control group.

    PubMed

    Kim, S W; Hoover, K M

    1996-02-01

    We administered the Tridimensional Personality Questionnaire to 40 control subjects and to 47 social phobia patients who met Structured Clinical Interview for DSM-III-R (SCID) criteria for social phobia and participated in a multicenter treatment study. Multiple comparisons with Bonferroni correction showed a significant increase in total Harm Avoidance scale scores and all four subscale scores for the social phobia group. On a Reward Dependence subscale that measures persistence versus irresoluteness the mean was significantly lower in the social phobia group than the control group. Present findings extend an earlier report of increased Harm Avoidance in major depressive disorder and other clinical diagnostic groups.

  10. Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study.

    PubMed

    Tangen, Jon-Magnus; Tierens, Anne; Caers, Jo; Binsfeld, Marilene; Olstad, Ole Kristoffer; Trøseid, Anne-Marie Siebke; Wang, Junbai; Tjønnfjord, Geir Erland; Hetland, Geir

    2015-01-01

    Forty patients with multiple myeloma scheduled to undergo high dose chemotherapy with autologous stem cell support were randomized in a double blinded fashion to receive adjuvant treatment with the mushroom extract AndoSan, containing 82% of Agaricus blazei Murrill (19 patients) or placebo (21 patients). Intake of the study product started on the day of stem cell mobilizing chemotherapy and continued until the end of aplasia after high dose chemotherapy, a period of about seven weeks. Thirty-three patients were evaluable for all study endpoints, while all 40 included patients were evaluable for survival endpoints. In the leukapheresis product harvested after stem cell mobilisation, increased percentages of Treg cells and plasmacytoid dendritic cells were found in patients receiving AndoSan. Also, in this group, a significant increase of serum levels of IL-1ra, IL-5, and IL-7 at the end of treatment was found. Whole genome microarray showed increased expression of immunoglobulin genes, Killer Immunoglobulin Receptor (KIR) genes, and HLA genes in the Agaricus group. Furthermore, AndoSan displayed a concentration dependent antiproliferative effect on mouse myeloma cells in vitro. There were no statistically significant differences in treatment response, overall survival, and time to new treatment. The study was registered with Clinicaltrials.gov NCT00970021.

  11. Immunomodulatory Effects of the Agaricus blazei Murrill-Based Mushroom Extract AndoSan in Patients with Multiple Myeloma Undergoing High Dose Chemotherapy and Autologous Stem Cell Transplantation: A Randomized, Double Blinded Clinical Study

    PubMed Central

    Tierens, Anne; Caers, Jo; Binsfeld, Marilene; Olstad, Ole Kristoffer; Trøseid, Anne-Marie Siebke; Wang, Junbai; Tjønnfjord, Geir Erland; Hetland, Geir

    2015-01-01

    Forty patients with multiple myeloma scheduled to undergo high dose chemotherapy with autologous stem cell support were randomized in a double blinded fashion to receive adjuvant treatment with the mushroom extract AndoSan, containing 82% of Agaricus blazei Murrill (19 patients) or placebo (21 patients). Intake of the study product started on the day of stem cell mobilizing chemotherapy and continued until the end of aplasia after high dose chemotherapy, a period of about seven weeks. Thirty-three patients were evaluable for all study endpoints, while all 40 included patients were evaluable for survival endpoints. In the leukapheresis product harvested after stem cell mobilisation, increased percentages of Treg cells and plasmacytoid dendritic cells were found in patients receiving AndoSan. Also, in this group, a significant increase of serum levels of IL-1ra, IL-5, and IL-7 at the end of treatment was found. Whole genome microarray showed increased expression of immunoglobulin genes, Killer Immunoglobulin Receptor (KIR) genes, and HLA genes in the Agaricus group. Furthermore, AndoSan displayed a concentration dependent antiproliferative effect on mouse myeloma cells in vitro. There were no statistically significant differences in treatment response, overall survival, and time to new treatment. The study was registered with Clinicaltrials.gov NCT00970021. PMID:25664323

  12. Tailored balance exercises on people with multiple sclerosis: A pilot randomized, controlled study.

    PubMed

    Brichetto, Giampaolo; Piccardo, Elisa; Pedullà, Ludovico; Battaglia, Mario Alberto; Tacchino, Andrea

    2015-07-01

    Altered integration of signals from visual (VIS), somatosensory (PROP) and vestibular system (VEST) lead to balance control impairments affecting the daily living activities of patients with multiple sclerosis (PwMS). As a consequence, tailored interventions could be crucial in improving efficacy of balance rehabilitation treatments. The objective of this paper is to assess the efficacy of tailored rehabilitation treatments for balance disorders based on visual, somatosensory and vestibular deficits versus traditional rehabilitation exercises. Thirty-two PwMS were assessed with the Berg Balance Scale (BBS), the composite score (CS) obtained by computerized dynamic posturography (CDP) test and the Modified Fatigue Impact Scale (MFIS). Based on CDP analysis, prevalent VIS, PROP or VEST deficits were identified and patients randomly allocated to a personalized (PRG) or traditional (TRG) rehabilitation group. BBS score showed a significant difference between pre- and post-treatment scores of 6.3 and 2.0 points respectively for PRG and TRG. CS showed a significant difference between pre- and post-treatment scores of 16.6 and 7.6 points respectively for PRG and TRG. No interaction effect was found for MFIS score. BBS and CS showed changes in the PRG group that met clinical relevant difference, underlining that tailored rehabilitation interventions based on patient-specific sensory system impairment could improve balance and postural control in PwMS. © The Author(s), 2015.

  13. The MUK five protocol: a phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib (Velcade) and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma.

    PubMed

    Brown, Sarah; Hinsley, Samantha; Ballesteros, Mónica; Bourne, Sue; McGarry, Paul; Sherratt, Debbie; Flanagan, Louise; Gregory, Walter; Cavenagh, Jamie; Owen, Roger; Williams, Cathy; Kaiser, Martin; Low, Eric; Yong, Kwee

    2016-01-01

    Multiple myeloma is a plasma cell tumour with an annual incidence in the UK of approximately 40-50 per million i.e. about 4500 new cases per annum. The triple combination cyclophosphamide, bortezomib (Velcade®) and dexamethasone (CVD) is an effective regimen at relapse and has emerged in recent years as the standard therapy at first relapse in the UK. Carfilzomib has good activity as a single agent in the relapsed setting, and it is expected that efficacy will be improved when used in combination with dexamethasone and cyclophosphamide. MUK Five is a phase II open label, randomised, controlled, parallel group, multi-centre trial that will compare the activity of carfilzomib, cyclophosphamide and dexamethasone (CCD) with that of CVD, given over an equivalent treatment period (24 weeks), in participants with multiple myeloma at first relapse, or refractory to no more than 1 line of treatment. In addition, the study also aims to assess the utility of a maintenance schedule of carfilzomib in these participants. The primary objective of the trial is to assess whether CCD provides non-inferior activity in terms of ≥ VGPR rates at 24 weeks, and whether the addition of maintenance treatment with carfilzomib to CCD provides superior activity in terms of progression-free survival, as compared to CCD with no maintenance. Secondary objectives include comparing toxicity profiles, further summarizing and comparing the activity of the different treatment arms and analysis of the effect of each treatment arm on minimal residual disease status. The development of carfilzomib offers the opportunity to further explore the anti-tumour efficacy of proteasome inhibition and, based on the available evidence, it is important and timely to obtain data on the activity, toxicity and tolerability of this drug. In contrast to ongoing phase III trials, this phase II trial has a unique subset of participants diagnosed with multiple myeloma at first relapse or refractory to no more than 1 line of treatment and will also evaluate the utility of maintenance with carfilzomib for up to 18 months and investigate minimal residual disease status to provide information on depth of response and the prognostic impact thereof. The trial is registered under ISRCTN17354232, December 2012.

  14. Improvement in quality of life and sexual functioning in a comorbid sample after the unified protocol transdiagnostic group treatment.

    PubMed

    de Ornelas Maia, Ana Claudia Corrêa; Sanford, Jenny; Boettcher, Hannah; Nardi, Antonio E; Barlow, David

    2017-10-01

    Patients with multiple mental disorders often experience sexual dysfunction and reduced quality of life. The unified protocol (UP) is a transdiagnostic treatment for emotional disorders that has the potential to improve quality of life and sexual functioning via improved emotion management. The present study evaluates changes in quality of life and sexual functioning in a highly comorbid sample treated with the UP in a group format. Forty-eight patients were randomly assigned to either a UP active-treatment group or a medication-only control group. Treatment was delivered in 14 sessions over the course of 4 months. Symptoms of anxiety and depression were assessed using the Beck Anxiety Inventory and Beck Depression Inventory. Sexual functioning was assessed by the Arizona Sexual Experience Scale (ASEX), and quality of life was assessed by the World Health Organization Quality of Life-BREF scale (WHOQOL-BREF). Quality of life, anxiety and depression all significantly improved among participants treated with the UP. Some improvement in sexual functioning was also noted. The results support the efficacy of the UP in improving quality of life and sexual functioning in comorbid patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Multi-antioxidant supplementation does not prevent an increase in gut permeability after lower torso ischemia and reperfusion in humans.

    PubMed

    Wijnen, M H W A; Vader, H L; Roumen, R M H

    2002-01-01

    An increase in gut permeability can have serious consequences leading to sepsis and multiple organ failure. After lower torso ischemia an increase in gut permeability is seen in both animals and humans. There is proof that this can be modified by antioxidant supplementation. In this prospective, randomized study we have looked at the influence of a multiantioxidant supplementation regime, using allopurinol, vitamins E and C, mannitol and N-acetylcysteine, perioperatively. Twenty-two patients received standard treatment and 20 patients received supplementation. Gut permeability was determined using a double sugar test with lactulose and rhamnose. A significant increase in gut permeability was found neither in the non-treatment group (p = 0.012) nor in the treatment group (p = 0.006) after 6 and 24 h. No difference was found between the group receiving antioxidants and the standard treatment group. p = 0.93 6 h post clamp; p = 0.97 24 h post clamp. In this study we have not found an influence of multiantioxidant supplementation on gut permeability after lower torso ischemia. Possible explanations for this negative result are being discussed. Copyright 2002 S. Karger AG, Basel

  16. Music therapy CD creation for initial pediatric radiation therapy: a mixed methods analysis.

    PubMed

    Barry, Philippa; O'Callaghan, Clare; Wheeler, Greg; Grocke, Denise

    2010-01-01

    A mixed methods research design was used to investigate the effects of a music therapy CD (MTCD) creation intervention on pediatric oncology patients' distress and coping during their first radiation therapy treatment. The music therapy method involved children creating a music CD using interactive computer-based music software, which was "remixed" by the music therapist-researcher to extend the musical material. Eleven pediatric radiation therapy outpatients aged 6 to 13 years were randomly assigned to either an experimental group, in which they could create a music CD prior to their initial treatment to listen to during radiation therapy, or to a standard care group. Quantitative and qualitative analyses generated multiple perceptions from the pediatric patients, parents, radiation therapy staff, and music therapist-researcher. Ratings of distress during initial radiation therapy treatment were low for all children. The comparison between the two groups found that 67% of the children in the standard care group used social withdrawal as a coping strategy, compared to 0% of the children in the music therapy group; this trend approached significance (p = 0.076). MTCD creation was a fun, engaging, and developmentally appropriate intervention for pediatric patients, which offered a positive experience and aided their use of effective coping strategies to meet the demands of their initial radiation therapy treatment.

  17. Clinical application of autologous fibroblast cell culture in gingival recession treatment.

    PubMed

    Milinkovic, I; Aleksic, Z; Jankovic, S; Popovic, O; Bajic, M; Cakic, S; Lekovic, V

    2015-06-01

    Gingival recession is defined as soft and hard tissue displacement resulting in root surface exposure. The optimal outcome of gingival recession treatment is complete, predictable and long-lasting root coverage with a significant level of tissue regeneration. Tissue engineering, which applies active regeneration principles, presents the contemporary treatment approach in the restitution and regeneration of lost tissues. The objective of the present study was to evaluate and compare the clinical results of application of an autologous fibroblast cell culture (AFCC) on a collagen matrix and a connective tissue graft (CTG) placed under a coronally advanced flap (CAF), in the treatment of single and multiple gingival recessions. Eighteen patients from the Department of Periodontology, School of Dentistry, University of Belgrade, were randomly enrolled in this study. Inclusion criteria were the bilateral presence of Miller Class I or II single or multiple maxillary gingival recessions. A split-mouth design was used in the study. The experimental group was treated with AFCC on a collagen scaffold, which was placed under a CAF. The control group received a combination of CTG and CAF. Clinical parameters such as gingival recession coverage, keratinized tissue width, clinical attachment level and gingival index were recorded at baseline and at 12 mo postoperatively. The oral hygiene level was assessed by plaque index evaluation. Postoperative healing was evaluated through the healing index, recorded 1, 2 and 3 wk postoperatively. The final esthetic outcome was assessed using the mean root coverage esthetic score (RES). Statistically significant improvement of all parameters assessed was found compared with baseline. A statistically significant difference between groups was observed only in keratinized tissue width. Greater keratinized tissue width is still obtained with the use of CTG. Regarding the tissue-healing results, no statistically significant difference was achieved. The RES results were similar for both groups. Within the limitations of the present study, both procedures proved to be efficient in gingival recession treatment. AFCC, as a novel tissue-engineering concept and living cell-based therapy, proved to be a reliable and successful treatment concept. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Comparative efficacy of switching to natalizumab in active multiple sclerosis

    PubMed Central

    Spelman, Timothy; Kalincik, Tomas; Zhang, Annie; Pellegrini, Fabio; Wiendl, Heinz; Kappos, Ludwig; Tsvetkova, Larisa; Belachew, Shibeshih; Hyde, Robert; Verheul, Freek; Grand-Maison, Francois; Izquierdo, Guillermo; Grammond, Pierre; Duquette, Pierre; Lugaresi, Alessandra; Lechner-Scott, Jeannette; Oreja-Guevara, Celia; Hupperts, Raymond; Petersen, Thor; Barnett, Michael; Trojano, Maria; Butzkueven, Helmut

    2015-01-01

    Objective To compare treatment efficacy and persistence in patients who switched to natalizumab versus those who switched between glatiramer acetate (GA) and interferon-beta (IFNβ) after an on-treatment relapse on IFNβ or GA using propensity score matched real-world datasets. Methods Patients included were registered in MSBase or the TYSABRI Observational Program (TOP), had relapsed on IFNβ or GA within 12 months prior to switching to another therapy, and had initiated natalizumab or IFNβ/GA treatment ≤6 months after discontinuing prior therapy. Covariates were balanced across post switch treatment groups by propensity score matching at treatment initiation. Relapse, persistence, and disability measures were compared between matched treatment arms in the total population (n = 869/group) and in subgroups defined by prior treatment history (IFNβ only [n = 578/group], GA only [n = 165/group], or both IFNβ and GA [n = 176/group]). Results Compared to switching between IFNβ and GA, switching to natalizumab reduced annualized relapse rate in year one by 65–75%, the risk of first relapse by 53–82% (mean follow-up 1.7–2.2 years) and treatment discontinuation events by 48–65% (all P ≤ 0.001). In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch. Interpretation Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed. Results were consistent regardless of the prior treatment identity. PMID:25909083

  19. Clinical importance of detecting exaggerated blood pressure response to exercise on antihypertensive therapy.

    PubMed

    Mizuno, Reiko; Fujimoto, Shinichi; Saito, Yoshihiko; Yamazaki, Masaharu

    2016-06-01

    In patients with hypertension, regression of left ventricular hypertrophy (LVH) is associated with improved prognosis. Impact of exaggerated blood pressure response to exercise (Ex-BP) seen in patients with hypertension undergoing antihypertensive therapy on the regression of LVH has not been evaluated. This prospective study investigated the relationship between Ex-BP on antihypertensive therapy and the regression of LVH. We prospectively studied 124 never-treated patients with hypertension with LVH. After a pretreatment evaluation, antihypertensive treatment was started and exercise test was performed in all patients. Patients with Ex-BP were divided into the Ex-BP (+) group and those without were divided into the Ex-BP (-) group. Regression of LVH over the follow-up period was compared between the groups. The follow-up duration was approximately 12 months in both the groups. Mean values of blood pressure at rest during the follow-up period were similar between the groups. Reduction of LVH was seen in both the groups. The magnitude of reduction of LVH was significantly smaller in the Ex-BP (+) group compared with the Ex-BP (-) group. Regression of LVH was much frequently seen in the Ex-BP (+) group compared with the Ex-BP (-) group. Multiple regression analysis determined that on-treatment Ex-BP was an independent negative determinant of antihypertensive treatment-induced reduction of LVH. This study suggests that on-treatment Ex-BP is associated with depressed regression of LVH in patients with hypertension with antihypertensive treatment. If Ex-BP is detected despite receiving antihypertensive agents, improvement of Ex-BP may be necessary to achieve an effective reduction of LVH. Active search of Ex-BP is recommended in patients with hypertension with antihypertensive treatment. 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/

  20. Feasibility of a Friendship Network-Based Pediatric Obesity Intervention.

    PubMed

    Giannini, Courtney M; Irby, Megan B; Skelton, Joseph A; Gesell, Sabina B

    2017-02-01

    There is growing evidence supporting social network-based interventions for adolescents with obesity. This study's aim was to determine the feasibility of a social network-based intervention by assessing adolescents' friendship networks, willingness to involve friends in treatment, and how these factors influence enjoyment. Adolescents (N = 42) were recruited from a tertiary care obesity clinic. Participants gave a list of closest friends, friendship characteristics, and which of their friends they would involve in treatment. A subset (N = 14) participated in group treatment, were encouraged to bring friends, and invited to a second interview. Participants nominated a mean of 4.0 (standard deviation [SD] = 1.6) friends and were more likely to nominate closer friends (p = 0.003). Friends who attended group sessions were more likely to have multiple friendships in common with the participant's own network (p = 0.04). Involving friends in treatment is feasible and desired by adolescents and may be a novel approach for augmenting obesity treatment outcomes.

  1. Computer-Based Cognitive Training for Executive Functions after Stroke: A Systematic Review

    PubMed Central

    van de Ven, Renate M.; Murre, Jaap M. J.; Veltman, Dick J.; Schmand, Ben A.

    2016-01-01

    Background: Stroke commonly results in cognitive impairments in working memory, attention, and executive function, which may be restored with appropriate training programs. Our aim was to systematically review the evidence for computer-based cognitive training of executive dysfunctions. Methods: Studies were included if they concerned adults who had suffered stroke or other types of acquired brain injury, if the intervention was computer training of executive functions, and if the outcome was related to executive functioning. We searched in MEDLINE, PsycINFO, Web of Science, and The Cochrane Library. Study quality was evaluated based on the CONSORT Statement. Treatment effect was evaluated based on differences compared to pre-treatment and/or to a control group. Results: Twenty studies were included. Two were randomized controlled trials that used an active control group. The other studies included multiple baselines, a passive control group, or were uncontrolled. Improvements were observed in tasks similar to the training (near transfer) and in tasks dissimilar to the training (far transfer). However, these effects were not larger in trained than in active control groups. Two studies evaluated neural effects and found changes in both functional and structural connectivity. Most studies suffered from methodological limitations (e.g., lack of an active control group and no adjustment for multiple testing) hampering differentiation of training effects from spontaneous recovery, retest effects, and placebo effects. Conclusions: The positive findings of most studies, including neural changes, warrant continuation of research in this field, but only if its methodological limitations are addressed. PMID:27148007

  2. Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists.

    PubMed

    Heesen, Christoph; Kleiter, Ingo; Nguyen, Franziska; Schäffler, Nina; Kasper, Jürgen; Köpke, Sascha; Gaissmaier, Wolfgang

    2010-12-01

    Natalizumab is associated with the potentially life-threatening side-effect progressive multifocal leukoencephalopathy (PML). Little is known about patients' and physicians' risk estimates and attitudes towards natalizumab treatment. Consecutive natalizumab-treated patients (n = 69) and neurologists (n = 66) in two centres and cooperating private practices received an evidence-based three-page information leaflet about natalizumab-associated PML and an evaluation sheet. After reading the information, patients were significantly more likely than physicians to intend continuation of natalizumab treatment and willing to accept higher risks of PML: 49% of physicians would stop treatment at a PML risk of 2:10,000 or lower, while only 17% of patients would do so (p < 0.001). This difference could not be explained by risk calculation abilities or lack of understanding. Both groups overestimated natalizumab treatment effects. Patients had a significantly worse perception of multiple sclerosis as a malignant disease. We conclude that patients were willing to accept a higher risk of PML than neurologists. Coherent with their perception of risks and benefits, patients were also more willing to continue treatment. Open information about treatment-related risks is appreciated and might support shared decision making.

  3. Relationship between socioeconomic status and accessibility for endoscopic resection among gastric cancer patients: using National Health Insurance Cohort in Korea: poverty and endoscopic resection.

    PubMed

    Kim, Na Yeon; Oh, Jun Seok; Choi, Young; Shin, Jaeyong; Park, Eun-Cheol

    2017-01-01

    Gastric cancer is one of the most common types of cancer among patients in Korea. We measured the inequity in accessibility to endoscopic mucosal/submucosal resection (EMR) for early and curable gastric cancer treatment among different income classes in patients diagnosed from late 2011 to 2013. Data were obtained from the National Health Insurance Cooperation Claim Data from patients diagnosed from late 2011 until the end of 2013, to provide a total of 1,671 patients with newly diagnosed carcinoma in situ of gastric and gastric cancer among 1,025,340 enrollees. Multiple logistic regression analysis was conducted to investigate the associations between independent variables and the rate of treatment with EMR. Among 1671 gastric cancer patients, 317 (19.0 %) subjects were treated with EMR. The 'lowest' income group was associated with a statistically significant lower rate of EMR treatment [odds ratio (OR) = 0.55, 95 % confidence index (CI) 0.34-0.89] compared to the 'highest' income group. The ORs for the 'low-middle' and 'middle-high' income groups were both higher than for the reference group, although these were not significantly different. According to the subgroup analysis by gender, rate of EMR treatment of 'lowest' income group (OR = 0.37, 95 % CI 0.18-0.74) was significantly lower only among men. In conclusion, we suggest that although universal health insurance in Korea has covered EMR treatment since August 2011, patients from the lowest income group are less likely to receive this treatment. Thus, we need to detect more eligible early-stage gastric cancer and treatment for individuals of low socioeconomic status.

  4. Gambling disorder in financial markets: Clinical and treatment-related features

    PubMed Central

    Shin, Young-Chul; Choi, Sam-Wook; Ha, Juwon; Choi, Jung-Seok; Kim, Dai-Jin

    2015-01-01

    Background and Aims To date, few studies have examined the clinical manifestation of disordered gamblers in financial markets. This study examined the differences in the clinical and treatment-related features of gambling disorder between financial markets and horse races. Methods Subjects who met the DSM-IV criteria for pathological gambling (PG) and who sought treatment were assessed by retrospective chart review. One hundred forty-four subjects were included in this sample, which consisted of the following groups: financial markets (n = 45; 28.6%) and horse races (n = 99; 71.4%). Results Multiple similar manifestations were found between the groups, including severity of PG, age of PG onset, amounts of gambling debts, drinking days per week, depressive mood, duration of seeking treatment after the onset of PG, and treatment follow-up duration. However, disordered gamblers who invested in the financial market were significantly more likely to be educated (p = 0.003), live with their spouses (p = 0.007), have full-time jobs (p = 0.006), and they were more likely to participate in the first type of gambling than the horse races group (p<0.001). Furthermore, the financial markets group received the anti-craving medication less often than the horse races group (p = 0.04). Discussion and Conclusions: These findings suggest that disordered gamblers in financial markets show different socio-demographic, clinical and treatment-related features compared with the horse race gamblers, despite a similar severity of gambling disorder. Understanding these differential manifestations may provide insight into prevention and treatment development for specific types of gambling. PMID:26690619

  5. Gambling disorder in financial markets: Clinical and treatment-related features.

    PubMed

    Shin, Young-Chul; Choi, Sam-Wook; Ha, Juwon; Choi, Jung-Seok; Kim, Dai-Jin

    2015-12-01

    To date, few studies have examined the clinical manifestation of disordered gamblers in financial markets. This study examined the differences in the clinical and treatment-related features of gambling disorder between financial markets and horse races. Subjects who met the DSM-IV criteria for pathological gambling (PG) and who sought treatment were assessed by retrospective chart review. One hundred forty-four subjects were included in this sample, which consisted of the following groups: financial markets (n = 45; 28.6%) and horse races (n = 99; 71.4%). Multiple similar manifestations were found between the groups, including severity of PG, age of PG onset, amounts of gambling debts, drinking days per week, depressive mood, duration of seeking treatment after the onset of PG, and treatment follow-up duration. However, disordered gamblers who invested in the financial market were significantly more likely to be educated (p = 0.003), live with their spouses (p = 0.007), have full-time jobs (p = 0.006), and they were more likely to participate in the first type of gambling than the horse races group (p<0.001). Furthermore, the financial markets group received the anti-craving medication less often than the horse races group (p = 0.04). These findings suggest that disordered gamblers in financial markets show different socio-demographic, clinical and treatment-related features compared with the horse race gamblers, despite a similar severity of gambling disorder. Understanding these differential manifestations may provide insight into prevention and treatment development for specific types of gambling.

  6. Attenuated nicotine-like effects of varenicline but not other nicotinic ACh receptor agonists in monkeys receiving nicotine daily.

    PubMed

    Cunningham, Colin S; Moerke, Megan J; Javors, Martin A; Carroll, F Ivy; McMahon, Lance R

    2016-12-01

    Chronic treatment can differentially impact the effects of pharmacologically related drugs that differ in receptor selectivity and efficacy. The impact of daily nicotine treatment on the effects of nicotinic ACh receptor (nAChR) agonists was examined in two groups of rhesus monkeys discriminating nicotine (1.78 mg·kg -1 base weight) from saline. One group received additional nicotine treatment post-session (1.78 mg·kg -1 administered five times daily, each dose 2 h apart; i.e. Daily group), and the second group did not (Intermittent group). Daily repeated nicotine treatment produced a time-related increase in saliva cotinine. There was no significant difference in the ED 50 values of the nicotine discriminative stimulus between the Daily and Intermittent group. Mecamylamine antagonized the effects of nicotine, whereas dihydro-β-erythroidine did not. Midazolam produced 0% nicotine-lever responding. The nAChR agonists epibatidine, RTI-36, cytisine and varenicline produced >96% nicotine-lever responding in the Intermittent group. The respective maximum effects in the Daily group were 100, 72, 59 and 28%, which shows that the ability of varenicline to produce nicotine-like responding was selectively decreased in the Daily as compared with the Intermittent group. When combined with nicotine, both varenicline and cytisine increased the potency of nicotine to produce discriminative stimulus effects. Nicotine treatment has a greater impact on the sensitivity to the effects of varenicline as compared with some other nAChR agonists. Collectively, these results strongly suggest that varenicline differs from nicotine in its selectivity for multiple nAChR subtypes. © 2016 The British Pharmacological Society.

  7. Attenuated nicotine‐like effects of varenicline but not other nicotinic ACh receptor agonists in monkeys receiving nicotine daily

    PubMed Central

    Cunningham, Colin S; Moerke, Megan J; Javors, Martin A; Carroll, F Ivy

    2016-01-01

    Background and Purpose Chronic treatment can differentially impact the effects of pharmacologically related drugs that differ in receptor selectivity and efficacy. Experimental Approach The impact of daily nicotine treatment on the effects of nicotinic ACh receptor (nAChR) agonists was examined in two groups of rhesus monkeys discriminating nicotine (1.78 mg·kg−1 base weight) from saline. One group received additional nicotine treatment post‐session (1.78 mg·kg−1 administered five times daily, each dose 2 h apart; i.e. Daily group), and the second group did not (Intermittent group). Key Results Daily repeated nicotine treatment produced a time‐related increase in saliva cotinine. There was no significant difference in the ED50 values of the nicotine discriminative stimulus between the Daily and Intermittent group. Mecamylamine antagonized the effects of nicotine, whereas dihydro‐β‐erythroidine did not. Midazolam produced 0% nicotine‐lever responding. The nAChR agonists epibatidine, RTI‐36, cytisine and varenicline produced >96% nicotine‐lever responding in the Intermittent group. The respective maximum effects in the Daily group were 100, 72, 59 and 28%, which shows that the ability of varenicline to produce nicotine‐like responding was selectively decreased in the Daily as compared with the Intermittent group. When combined with nicotine, both varenicline and cytisine increased the potency of nicotine to produce discriminative stimulus effects. Conclusion and Implications Nicotine treatment has a greater impact on the sensitivity to the effects of varenicline as compared with some other nAChR agonists. Collectively, these results strongly suggest that varenicline differs from nicotine in its selectivity for multiple nAChR subtypes. PMID:27667659

  8. Surgical Management of Gynecomastia: Subcutaneous Mastectomy and Liposuction.

    PubMed

    Kim, Dae Hwa; Byun, Il Hwan; Lee, Won Jai; Rah, Dong Kyun; Kim, Ji Ye; Lee, Dong Won

    2016-12-01

    The treatment of gynecomastia depends on multiple factors, and the best modality is controversial. In this study, we aimed to determine the best management approach by comparing outcomes of two groups of patients with gynecomastia who received subcutaneous mastectomy combined with liposuction and liposuction only. We conducted a retrospective analysis of 64 patients who underwent surgery for gynecomastia. We divided the patients into two groups: group A, patients who underwent liposuction only; and group B, patients who underwent liposuction and subcutaneous mastectomy. The serial photographs of all patients were clinically evaluated with respect to size, shape, scarring, and overall outcome by three plastic surgeons, and patient satisfaction was surveyed with regard to palpable lumps, size, shape, scarring, and overall outcome. Of the 64 subjects, 16 received liposuction only, and 48 received the combination procedure. A total of 125 breasts were involved. The doctors' scores for size and overall outcome were significantly better in the combination group, whereas scarring was better in the liposuction-only group. Similarly, patient satisfaction regarding size was significantly higher in the combination group, and satisfaction regarding scarring was significantly higher in the liposuction-only group. The scores for scarring in the combination treatment group were acceptable. Our study shows that combination treatment with liposuction and subcutaneous mastectomy results in satisfactory outcomes, including the extent of scarring. We conclude that this combination treatment should be recommended as the standard surgical treatment for gynecomastia and can provide excellent results in cases where glandular tissue needs to be removed. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  9. Tooth demineralization and associated factors in patients on fixed orthodontic treatment.

    PubMed

    Salmerón-Valdés, Elías Nahúm; Lara-Carrillo, Edith; Medina-Solís, Carlo Eduardo; Robles-Bermeo, Norma Leticia; Scougall-Vilchis, Rogelio José; Casanova-Rosado, Juan Fernando; Pontigo-Loyola, América Patricia; Fernández Barrera, Miguel Ángel

    2016-11-02

    Dental demineralization was determined in patients at three time points during fixed orthodontic treatment. A multiple cross-sectional study included 108 patients divided into three different groups: (1) beginning of orthodontic treatment; (2) one year into treatment; and (3) two years into treatment. Demineralization was estimated using a DIAGNOdent pen. We obtained data from multiple tooth-by-tooth demineralization readings combined with salivary pH and patients' oral hygienic and dietary behaviors. A t-test for independent samples and Spearman´s correlation were performed. No demineralizations differences were found between the initial stage and one year into treatment. Between one and two years small differences were observed, but demineralization increased between the initial stage and second treatment year, predominating in upper right central incisors (p = 0.056), upper left lateral incisors (p = 0.040), both upper canines (p = 0.055 and p = 0.040, respectively) and first left premolars (p = 0.034 and p = 0.053, respectively). We did not find associations between oral hygiene and dietary behaviours or salivary pH. In conclusion, demineralization occurred in first year of treatment and increased during second year, predominating in the upper arch and the left side mainly in upper right central incisors, upper left lateral incisors, both upper canines, and first left premolars.

  10. Coinfection with hepatitis C virus and schistosomiasis: Fibrosis and treatment response

    PubMed Central

    Abdel-Rahman, Mahasen; El-Sayed, Mohammad; El Raziky, Maissa; Elsharkawy, Aisha; El-Akel, Wafaa; Ghoneim, Hossam; Khattab, Hany; Esmat, Gamal

    2013-01-01

    AIM: To assess whether schistosomiasis coinfection with chronic hepatitis C virus (HCV) influences hepatic fibrosis and pegylated-interferon/ribavirin (PEG-IFN/RIB) therapy response. METHODS: This study was designed as a retrospective analysis of 3596 chronic HCV patients enrolled in the Egyptian National Program for HCV treatment with PEG-IFN/RIB. All patients underwent liver biopsy and anti-schistosomal antibodies testing prior to HCV treatment. The serology results were used to categorize the patients into group A (positive schistosomal serology) or group B (negative schistosomal serology). Patients in group A were given oral antischistosomal treatment (praziquantel, single dose) at four weeks prior to PEG-IFN/RIB. All patients received a 48-wk course of PEG-IFN (PEG-IFNα2a or PEG-IFNα2b)/RIB therapy. Clinical and laboratory follow-up examinations were carried out for 24 wk after cessation of therapy (to week 72). Correlations of positive schistosomal serology with fibrosis and treatment response were assessed by multiple regression analysis. RESULTS: Schistosomal antibody was positive in 27.3% of patients (15.9% females and 84.1% males). The patients in group A were older (P = 0.008) and had a higher proportion of males (P = 0.002) than the patients in group B. There was no significant association between fibrosis stage and positive schistosomal serology (P = 0.703). Early virological response was achieved in significantly more patients in group B than in group A (89.4% vs 86.5%, P = 0.015). However, significantly more patients in group A experienced breakthrough at week 24 than patients in group B (36.3% vs 32.3%, P = 0.024). End of treatment response was achieved in more patients in group B than in group A (62.0% vs 59.1%) but the difference did not reach statistical significance (P = 0.108). Sustained virological response occurred in significantly more patients in group B than in group A (37.6% vs 27.7%, P = 0.000). Multivariate logistic regression analysis of patient data at treatment weeks 48 and 72 showed that positive schistosomal serology was associated with failure of response to treatment at week 48 (OR = 1.3, P = 0.02) and at week 72 (OR = 1.7, P < 0.01). CONCLUSION: Positive schistosomal serology has no effect on fibrosis staging but is significantly associated with failure of response to HCV treatment despite antischistosomal therapy. PMID:23674877

  11. High-risk multiple myeloma: a multifaceted entity, multiple therapeutic challenges.

    PubMed

    Muchtar, Eli; Magen, Hila; Gertz, Morie A

    2017-06-01

    The term high-risk multiple myeloma is aimed to identify a heterogeneous group of patients who are more likely to progress and die early of their disease. Therefore, recognition of these patients is crucial. With the increase in the number of treatment options, the outcome for high-risk patients has probably improved, although the true extent of this improvement remains unknown, due to both the heterogeneous components of high-risk disease and its under-representation in clinical trials. In this article, we review the definitions of high-risk disease, emphasizing the fact that no single definition can represent the entire high-risk population. In the second part, we review the treatment options available for the management of high-risk myeloma as well as our general approach for high-risk disease. In light of the poor prognosis associated with high-risk myeloma, even in the current era, new approaches for the management of this subset of patients are needed.

  12. Cycle 1 as predictor of assisted reproductive technology treatment outcome over multiple cycles: an analysis of linked cycles from the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System online database.

    PubMed

    Stern, Judy E; Brown, Morton B; Luke, Barbara; Wantman, Ethan; Lederman, Avi; Hornstein, Mark D

    2011-02-01

    To determine whether the first cycle of assisted reproductive technology (ART) predicts treatment course and outcome. Retrospective study of linked cycles. Society for Assisted Reproductive Technology Clinic Outcome Reporting System database. A total of 6,352 ART patients residing or treated in Massachusetts with first treatment cycle in 2004-2005 using fresh, autologous oocytes and no prior ART. Women were categorized by first cycle as follows: Group I, no retrieval; Group II, retrieval, no transfer; Group III, transfer, no embryo cryopreservation; Group IV, transfer plus cryopreservation; and Group V, all embryos cryopreserved. None. Cumulative live-birth delivery per woman, use of donor eggs, intracytoplasmic sperm injection (ICSI), or frozen embryo transfers (FET). Groups differed in age, baseline FSH level, prior gravidity, diagnosis, and failure to return for Cycle 2. Live-birth delivery per woman for groups I through V for women with no delivery in Cycle I were 32.1%, 35.9%, 40.1%, 53.4%, and 51.3%, respectively. Groups I and II were more likely to subsequently use donor eggs (14.5% and 10.9%). Group II had the highest use of ICSI (73.3%); Group III had the lowest use of FET (8.9%). Course of treatment in the first ART cycle is related to different cumulative live-birth delivery rates and eventual use of donor egg, ICSI, and FET. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  13. A neural network - based algorithm for predicting stone -free status after ESWL therapy

    PubMed Central

    Seckiner, Ilker; Seckiner, Serap; Sen, Haluk; Bayrak, Omer; Dogan, Kazım; Erturhan, Sakip

    2017-01-01

    ABSTRACT Objective: The prototype artificial neural network (ANN) model was developed using data from patients with renal stone, in order to predict stone-free status and to help in planning treatment with Extracorporeal Shock Wave Lithotripsy (ESWL) for kidney stones. Materials and Methods: Data were collected from the 203 patients including gender, single or multiple nature of the stone, location of the stone, infundibulopelvic angle primary or secondary nature of the stone, status of hydronephrosis, stone size after ESWL, age, size, skin to stone distance, stone density and creatinine, for eleven variables. Regression analysis and the ANN method were applied to predict treatment success using the same series of data. Results: Subsequently, patients were divided into three groups by neural network software, in order to implement the ANN: training group (n=139), validation group (n=32), and the test group (n=32). ANN analysis demonstrated that the prediction accuracy of the stone-free rate was 99.25% in the training group, 85.48% in the validation group, and 88.70% in the test group. Conclusions: Successful results were obtained to predict the stone-free rate, with the help of the ANN model designed by using a series of data collected from real patients in whom ESWL was implemented to help in planning treatment for kidney stones. PMID:28727384

  14. Mixed-phenotype acute leukemia: state-of-the-art of the diagnosis, classification and treatment.

    PubMed

    Cernan, Martin; Szotkowski, Tomas; Pikalova, Zuzana

    2017-09-01

    Mixed-phenotype acute leukemia (MPAL) is a heterogeneous group of hematopoietic malignancies in which blasts show markers of multiple developmental lineages and cannot be clearly classified as acute myeloid or lymphoblastic leukemias. Historically, various names and classifications were used for this rare entity accounting for 2-5% of all acute leukemias depending on the diagnostic criterias used. The currently valid classification of myeloid neoplasms and acute leukemia published by the World Health Organization (WHO) in 2016 refers to this group of diseases as MPAL. Because adverse cytogenetic abnormalities are frequently present, MPAL is generally considered a disease with a poor prognosis. Knowledge of its treatment is limited to retrospective analyses of small patient cohorts. So far, no treatment recommendations verified by prospective studies have been published. The reported data suggest that induction therapy for acute lymphoblastic leukemia followed by allogeneic hematopoietic cell transplantation is more effective than induction therapy for acute myeloid leukemia or consolidation chemotherapy. The establishment of cooperative groups and international registries based on the recent WHO criterias are required to ensure further progress in understanding and treatment of MPAL. This review summarizes current knowledge on the diagnosis, classification, prognosis and treatment of MPAL patients.

  15. A Model for Evaluating Programs for the Gifted under Non-Experimental Conditions.

    ERIC Educational Resources Information Center

    Carter, Kyle R.

    1992-01-01

    The article presents and illustrates use of an evaluation model for assessing programs for the gifted where tight experimental control is not possible. The model consists of four components: ex post factor designs including intact groups; comparative evaluation; strength of treatment; and multiple outcome assessment from flexible data sources. (DB)

  16. Can School Counselors Deliver Cognitive-Behavioral Treatment for Social Anxiety Effectively? A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Masia Warner, Carrie; Colognori, Daniela; Brice, Chad; Herzig, Kathleen; Mufson, Laura; Lynch, Chelsea; Reiss, Philip T.; Petkova, Eva; Fox, Jeremy; Moceri, Dominic C.; Ryan, Julie; Klein, Rachel G.

    2016-01-01

    Background: Social anxiety disorder (SAD) typically onsets in adolescence and is associated with multiple impairments. Despite promising clinical interventions, most socially anxious adolescents remain untreated. To address this clinical neglect, we developed a school-based, 12-week group intervention for youth with SAD, "Skills for Academic…

  17. The Slope Test: Applications in Formative Evaluation.

    ERIC Educational Resources Information Center

    Baggaley, Jon; Brauer, Aaron-Henry

    1989-01-01

    Discusses problems with formative evaluation of educational materials and examines the slope test when used in a pretest/posttest multiple group (PPMG) design to adjust posttest scores treatment interaction studies. An example is given of the utility of the slope test and analysis of covariance procedure using an educational film about AIDS. (five…

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  19. The Relationship between Homework and Performance in an Introductory Operations Management Course.

    ERIC Educational Resources Information Center

    Peters, Michael; Kethley, Bryan; Bullington, Kimball

    2002-01-01

    Homework of 142 students in an operations management was graded and performance on a multiple-choice test was compared to that of 188 without graded homework. The treatment group had lower overall scores. Grading did not affect performance on quantitative questions but had a significant effect on nonquantitative questions. (SK)

  20. Reducing treatments in cattle superovulation protocols by combining a pituitary extract with a 5% hyaluronan solution: Is it able to diminish activation of the hypothalamic pituitary adrenal axis compared to the traditional protocol?

    PubMed

    Biancucci, Andrea; Sbaragli, Tatiana; Comin, Antonella; Sylla, Lakamy; Monaci, Maurizio; Peric, Tanja; Stradaioli, Giuseppe

    2016-03-15

    Traditional superovulation protocols that include multiple gonadotropin treatments are time-consuming and labor intensive. These protocols require multiple handling and restraining of embryo donors. This will likely increase the risks of injuries in both animals and humans and induce stress that may lead to a reduced superovulatory response. These are more evident when working with cattle that are rarely handled or raised on extensive grazing. The objectives of this experiment were to compare the efficacy of a split-injection protocol of porcine pituitary-derived porcine FSH (pFSH) preparation (slow release [SR] group) to the traditional 4-day treatment with pFSH administered twice daily (C group) and to determine the concentrations of cortisol in the hair as a marker of activation of the hypothalamic-pituitary-adrenal (HPA) axis during the two superovulatory treatments. Thirty-two heifers were stimulated twice in a 2 × 2 crossover design and compared for ovarian response and numbers and characteristics of recovered ova-embryo among treatments. No differences between SR and C groups were found in terms of percentage of responsive animals (100% vs. 93.8%) and ovulation rate (83.7 ± 1.1 vs. 79.5 ± 1.0%). A positive correlation was found between the number of follicles responsive to pFSH (2-8 mm) at the beginning of treatments and the superovulatory response, and no differences were found in these follicular populations between the two treatment groups. The numbers of CLs, ova-embryos, fertilized ova, transferable and freezable embryos recovered per cow were found to be significantly higher in SR compared with C group (14.0 ± 1.6 vs. 10.6 ± 1.0, 12.1 ± 1.6 vs. 7.6 ± 1.0, 11.1 ± 1.1 vs. 7.3 ± 1.0, 9.6 ± 1.4 vs. 6.6 ± 1.0, and 9.4 ± 1.4 vs. 6.0 ± 1.0 for SR and C group, respectively). The SR group produced also a significantly greater number of excellent- and/or good-quality embryos compared with the C group. The concentrations of cortisol in the hair at Days 14 and 21 were significantly greater in the C compared with the SR group (P < 0.05). In conclusion, these results indicate that the dilution of gonadotropin in a 5% hyaluronan solution, reducing the administration frequency, improves the quantitative and qualitative superovulatory response of Marchigiana heifers. Further studies using other breeds of cattle are needed to verify the results herein obtained and to confirm the lower activation of the hypothalamic-pituitary-adrenal axis caused in the donor by the split-injection protocol. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

    PubMed

    Haapamäki, Carola; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Grönroos, Juha; Saarela, Arto; Mustonen, Harri; Halttunen, Jorma

    2015-07-01

    The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747). © Georg Thieme Verlag KG Stuttgart · New York.

  2. Alternative Methods for Handling Attrition

    PubMed Central

    Foster, E. Michael; Fang, Grace Y.

    2009-01-01

    Using data from the evaluation of the Fast Track intervention, this article illustrates three methods for handling attrition. Multiple imputation and ignorable maximum likelihood estimation produce estimates that are similar to those based on listwise-deleted data. A panel selection model that allows for selective dropout reveals that highly aggressive boys accumulate in the treatment group over time and produces a larger estimate of treatment effect. In contrast, this model produces a smaller treatment effect for girls. The article's conclusion discusses the strengths and weaknesses of the alternative approaches and outlines ways in which researchers might improve their handling of attrition. PMID:15358906

  3. Oral vascular malformations: laser treatment and management

    NASA Astrophysics Data System (ADS)

    Romeo, U.; Rocchetti, F.; Gaimari, G.; Tenore, G.; Palaia, G.; Lo Giudice, G.

    2016-03-01

    Vascular malformations are a very heterogeneous group of circulatory system's diseases that can involve different kind of vessels: arterial, venous or lymphatic ones. Many treatments, such as conventional surgery, embolization, steroid therapy and laser therapy, are available for vascular lesions. The laser approach relies more therapeutic techniques: the transmucosal thermophotocoagulation, intralesional photocoagulation, the excisional biopsy. Today laser is demonstrated to be the gold standard technique to treat vascular lesions that allows a safe and efficient treatment and a lower post-operative healing time. The only disadvantage is the risk of carbonization that could be avoided by using the multiple-spot single pulsed wave technique.

  4. Comparative efficacy of whole-brain radiotherapy with and without elemene liposomes in patients with multiple brain metastases from non-small-cell lung carcinoma.

    PubMed

    Sun, Y N; Zhang, Z Y; Zeng, Y C; Chi, F; Jin, X Y; Wu, R

    2016-08-01

    We explored and compared the clinical effects of whole-brain radiotherapy (wbrt) with and without elemene liposomes in patients with multiple brain metastases from non-small-cell lung carcinoma (nsclc). We retrospectively analyzed 62 patients with multiple brain metastases from nsclc who received wbrt (30 Gy in 10 fractions) at Shengjing Hospital of China Medical University from January 2012 to May 2013. In 30 patients, elemene liposomes (400 mg) were injected intravenously via a peripherally inserted central catheter for 21 consecutive days from the first day of radiotherapy. Overall survival (os) and nervous system progression-free survival (npfs) for the two groups were compared by Kaplan-Meier analysis. Factors influencing npfs were examined by Cox regression analysis. Chi-square or Fisher exact tests were used for group comparisons. The median os was 9.0 months in the wbrt plus elemene group and 7.8 months in the wbrt-alone group (p = 0.581); the equivalent median npfs durations were 5.2 months and 3.7 months (p = 0.005). Patient treatment plan was an independent factor associated with npfs (p = 0.002). Tumour response and disease-control rates in the wbrt plus elemene group were 26.67% and 76.67% respectively; they were 18.75% and 62.5% in the wbrt group (p = 0.452). Compared with the patients in the wbrt-alone group, significantly fewer patients in the wbrt plus elemene group developed headaches (p = 0.04); quality of life was also significantly higher in the wbrt plus elemene group both at 1 month and at 2 months (p = 0.021 and p = 0.001 respectively). The addition of elemene liposomes to wbrt might prolong npfs in patients with multiple brain metastases from nsclc, while also reducing the incidence of headache and improving patient quality of life.

  5. Thoracic paravertebral block versus intravenous patient-controlled analgesia for pain treatment in patients with multiple rib fractures.

    PubMed

    Yeying, Ge; Liyong, Yuan; Yuebo, Chen; Yu, Zhang; Guangao, Ye; Weihu, Ma; Liujun, Zhao

    2017-12-01

    Objectives To assess the effect of thoracic paravertebral block (PVB) on pain management and preservation of pulmonary function compared with intravenous, patient-controlled analgesia (IVPCA) in patients with multiple rib fractures (MRFs). Methods Ninety patients with unilateral MRFs were included in this prospective study and randomly assigned to the TPVB or IVPCA group. The visual analogue scale (VAS) pain score, blood gas analysis, and bedside spirometry were measured and recorded at different time points after analgesia. Results TPVB and IVPCA provided good pain relief. VAS scores were significantly lower in the TPVB group than in the IVPCA group at rest and during coughing ( P < 0.05). Patients in the TPVB group had a higher PaO 2 and PaO 2 /FiO 2 and lower P (A-a) O 2 compared with the IVPCA group ( P < 0.05). Moreover, patients in the TPVB group showed higher FVC, FEV1/FVC, and PEFR, and fewer complications than did the IVPCA group ( P < 0.05). Conclusion TPVB is superior to IVPCA in pain relief and preservation of pulmonary function in patients with MRFs.

  6. Adherence to treatment in men with hypogonadotrophic hypogonadism.

    PubMed

    Dwyer, Andrew A; Tiemensma, Jitske; Quinton, Richard; Pitteloud, Nelly; Morin, Diane

    2017-03-01

    Men with congenital hypogonadotrophic hypogonadism (CHH) typically require lifelong hormonal therapy, and discontinuing treatment can have negative health consequences. Little is known about adherence to treatment or the psychosocial impact of CHH. A sequential, multiple methods approach was used. A quantitative online survey assessed adherence to treatment, depressive symptoms and illness perceptions. Subsequently, qualitative focus groups explored patient-reported factors for adherence. Adult men with CHH on at least 1 year of treatment were recruited internationally. Adherence (Morisky medication adherence scale), depressive symptoms (Zung self-rating depression scale) and patient perception of CHH (revised illness perception questionnaire) were assessed in an online survey, and comparisons were made to reference groups. Patient focus group discussions were conducted and thematic analysis was employed to identify patient-reported factors for adherence. In total, 101 men on long-term treatment were included (mean age 37 ± 11 years). Forty three percent (43/101) exhibited low medication adherence and a significantly elevated prevalence of mild, moderate or severe depressive symptoms (27%, 17%, 20%, respectively, all P < 0·001 vs reference population). Patients reported negative illness perceptions and significant psychosocial consequences. Focus group discussions (n = 3, 26 total patients) identified patient-, health professional- and healthcare system-related barriers as targets for improving adherence. Congenital hypogonadotrophic hypogonadism men are challenged to adhere to long-term treatment. Poor adherence may contribute to adverse effects on bone, sexual and psychological health. The psychosocial morbidity of CHH is significant and appears to be underappreciated by healthcare providers. © 2016 John Wiley & Sons Ltd.

  7. Effect of periodontal therapy on pregnancy outcome in women affected by periodontitis.

    PubMed

    Tarannum, Fouzia; Faizuddin, Mohamed

    2007-11-01

    There is convincing evidence to suggest that infections affecting the mother during pregnancy may produce alterations in the normal cytokine- and hormone-regulated gestation, which could result in preterm labor, premature rupture of membranes, and preterm birth (PTB). Studies in the late 1990s associated periodontitis with preterm low birth weight (PLBW) deliveries, and this may have similar pathogenic mechanisms as other maternal infections. This study determined the effect of non-surgical periodontal therapy on pregnancy outcome. A total of 200 pregnant women with periodontitis were randomly assigned to treatment and control groups. Detailed data about previous and current pregnancies were obtained. All women received a full-mouth periodontal examination, including oral hygiene index-simplified, bleeding index, and clinical attachment level. The women in the treatment group received non-surgical periodontal therapy during the gestational period, and those in the control group received periodontal treatment after delivery. Periodontal therapy included plaque control instructions and scaling and root planing performed under local anesthesia. The outcome measures assessed were gestational age and birth weight of the infant. PTB was recorded when delivery occurred at <37 weeks of gestation, and low birth weight (LBW) was recorded when the infant weighed<2,500 g. There were 53 PTBs in the treatment group and 68 PTBs in the control group. Twenty-six LBW infants were recorded in the treatment group, and 48 LBW infants were noted in the control group. The mean gestational ages were 33.8+/-2.8 weeks and 32.7+/-2.8 weeks in the treatment and control groups, respectively. The difference was statistically significant at P<0.006. The mean birth weight was 2,565.3+/-331.2 g in the treatment group and 2,459.6+/-380.7 g in the control group, with the difference being statistically significant at P<0.044. A multiple regression model showed a significant effect of periodontal treatment on birth outcomes. Non-surgical periodontal therapy can reduce the risk for preterm births in mothers who are affected by periodontitis. Additional multicentered, randomized, controlled clinical trials are required to confirm this link between periodontitis and PLBW.

  8. Prospective Evaluation of Transcatheter Arterial Chemoembolization (TACE) with Multiple Anti-Cancer Drugs (Epirubicin, Cisplatin, Mitomycin C, 5-Fluorouracil) Compared with TACE with Epirubicin for Treatment of Hepatocellular Carcinoma

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sahara, Shinya; Kawai, Nobuyuki; Sato, Morio, E-mail: morisato@mail.wakayama-med.ac.jp

    Purpose: To compare the efficacy of transcatheter arterial chemoembolization (TACE) using multiple anticancer drugs (epirubicin, cisplatin, mitomycin C, and 5-furuorouracil: Multi group) with TACE using epirubicin (EP group) for hepatocellular carcinoma (HCC). Materials and Methods: The study design was a single-center, prospective, randomized controlled trial. Patients with unrespectable HCC confined to the liver, unsuitable for radiofrequency ablation, were assigned to the Multi group or the EP group. We assessed radiographic response as the primary endpoint; secondary endpoints were progression-free survival (PFS), safety, and hepatic branch artery abnormality (Grade I, no damage or mild vessel wall irregularity; Grade II, overt stenosis;more » Grade III, occlusion; Grades II and III indicated significant hepatic artery damage). A total of 51 patients were enrolled: 24 in the Multi group vs. 27 in the EP group. Results: No significant difference in HCC patient background was found between the groups. Radiographic response, PFS, and 1- and 2-year overall survival of the Multi vs. EP group were 54% vs. 48%, 6.1 months vs. 8.7 months, and 95% and 65% vs. 85% and 76%, respectively, with no significant difference. Significantly greater Grade 3 transaminase elevation was found in the Multi group (p = 0.023). Hepatic artery abnormality was observed in 34% of the Multi group and in 17.1% of the EP group (p = 0.019). Conclusion: TACE with multiple anti-cancer drugs was tolerable but appeared not to contribute to an increase in radiographic response or PFS, and caused significantly more hepatic arterial abnormalities compared with TACE with epirubicin alone.« less

  9. Sandalwood oil prevent skin tumour development in CD1 mice.

    PubMed

    Dwivedi, C; Zhang, Y

    1999-10-01

    Sandalwood oil (SW oil) has been used for the treatment of inflammatory and eruptive skin diseases. In the present study, the chemopreventive effects of SW oil on 7,12-dimethylbenz(a)-anthracene (DMBA)-initiated and 12-O-tetradecanoylphorbol-13-acetate(TPA)-promoted skin tumour development and TPA-induced ornithine decarboxylase (ODC) activity in CD1 mice were investigated. Female CD1 mice (5-6 weeks old) were divided in different groups, having 30 mice in each group. One week after topical application of DMBA (200 nmole in 100 microl acetone) alone or with SW oil at different concentrations (100 microl, 1.25, 2.5, 3.75, 5% in acetone), at different times (0.5, 1, 2 h) before DMBA, the mice were treated topically with TPA (5 nmole in 100 microl acetone) alone or with SW oil at different concentrations (100 microl, 1.25, 2.5, 3.75, 5% in acetone) at different times (0.5, 1, 2 h) before TPA applications twice a week for 20 weeks. The mice were weighed and papillomas counted weekly. The results indicate that SW oil pre-treatment decreased the papilloma incidence and multiplicity in a concentration and time-dependent manner. The pre-treatment with 5% SW oil (100 microl) 1 h before DMBA and TPA treatments provided a maximum of 67% and 96% decrease in papilloma incidence and multiplicity, respectively, after 20 weeks of promotion. The mice pre-treated with SW oil at all concentrations and time period before TPA had significantly lower ODC activity than the group treated with TPA alone. The data suggest that SW oil could be an effective chemopreventive agent against chemically-induced skin cancer.

  10. Comparison of cyclophosphamide-thalidomide-dexamethasone to bortezomib-cyclophosphamide-dexamethasone as induction therapy for multiple myeloma patients in Brazil.

    PubMed

    Vigolo, Suelen; Zuckermann, Joice; Bittencourt, Rosane Isabel; Silla, Lúcia; Pilger, Diogo André

    2017-09-01

    Chemotherapy followed by autologous hematopoietic stem cell transplantation (HSCT) remains the standard treatment for multiple myeloma (MM). Thalidomide or bortezomib may be combined with cyclophosphamide and dexamethasone, in what are known as the CTD and VCD protocols, respectively. The objective of this study was to evaluate the clinical characteristics and response rates obtained with CTD and VCD, observing whether the inclusion of bortezomib to treat MM patients in Brazil increases therapeutic efficiency. Forty-three MM patients treated with induction protocols CTD and VCD between January 2010 and March 2015 were included. The parameters analyzed were staging, frequency of comorbidities prior to treatment, response rates obtained at each induction cycle, progression-free survival, and overall survival of patients. Very good partial response and complete response obtained with the VCD protocol were superior, compared with the CTD treatment. The presence of comorbidities was similar in the two groups, except kidney failure, which prevailed in the VCD group. Also, 78.3% and 48.3% of patients treated with the VCD and CTD protocols underwent autologous HSCT, respectively. In patients given the VCD protocol, 45.5% had complete response before autologous HSCT. Among those given CTD, this number was only 7.1% (p=0.023). Disease progression after autologous HSCT did not differ between the two groups. VCD afforded better responses than the CTD protocol, and improved patient condition before autologous HSCT. However, more studies are necessary including more patients and addressing various clinical conditions, besides the analysis of cost-effectiveness of these treatments. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

  11. Adequate antipsychotic treatment normalizes serum nerve growth factor concentrations in schizophrenia with and without cannabis or additional substance abuse.

    PubMed

    Jockers-Scherübl, Maria C; Rentzsch, Johannes; Danker-Hopfe, Heidi; Radzei, Nicole; Schürer, Falk; Bahri, Sharif; Hellweg, Rainer

    2006-06-12

    Neurotrophins such as nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) are important for the development and maintenance of neuron function. Neurodevelopment is thought to be impaired in schizophrenia, and vulnerable schizophrenic brains may be more sensitive to toxic influences. Thus, cannabis as a neurotoxin (and other substances) may be more harmful to schizophrenic brains than to non-schizophrenic brains, when used chronically. In a previous study we demonstrated an earlier disease onset and significantly higher serum NGF concentrations in drug-naïve schizophrenic patients with previous long-term cannabis abuse than in schizophrenics without cannabis abuse or cannabis abusers without schizophrenia. We therefore investigated whether this difference is still observed after treatment. Serum NGF measured in 114 treated schizophrenic patients (schizophrenia alone, n=66; schizophrenia plus cannabis abuse, n=42; schizophrenia plus multiple substance abuse, n=6) no longer differed significantly among those groups and from the control groups (healthy controls, n=51; cannabis controls, n=24; multiple substance controls, n=6). These results were confirmed by an additional prospective study in 28 patients suffering from schizophrenia (S) or schizophrenia with cannabis abuse (SC). Previously elevated serum NGF levels in the drug-naïve state, also differing between the groups (S: 83.44+/-265.25 pg/ml; SC: 246.89+/-310.24 pg/ml, S versus SC: p=0.03) dropped to 10.72+/-14.13 pg/ml (S) and 34.19+/-38.96 pg/ml (SC) (S versus SC, p>0.05), respectively, after adequate antipsychotic treatment. We thus conclude that antipsychotic treatment leads to recovery of neural integrity, as indicated by renormalized NGF values.

  12. Alendronate treatment alters bone tissues at multiple structural levels in healthy canine cortical bone.

    PubMed

    Acevedo, Claire; Bale, Hrishikesh; Gludovatz, Bernd; Wat, Amy; Tang, Simon Y; Wang, Mingyue; Busse, Björn; Zimmermann, Elizabeth A; Schaible, Eric; Allen, Matthew R; Burr, David B; Ritchie, Robert O

    2015-12-01

    Bisphosphonates are widely used to treat osteoporosis, but have been associated with atypical femoral fractures (AFFs) in the long term, which raises a critical health problem for the aging population. Several clinical studies have suggested that the occurrence of AFFs may be related to the bisphosphonate-induced changes of bone turnover, but large discrepancies in the results of these studies indicate that the salient mechanisms responsible for any loss in fracture resistance are still unclear. Here the role of bisphosphonates is examined in terms of the potential deterioration in fracture resistance resulting from both intrinsic (plasticity) and extrinsic (shielding) toughening mechanisms, which operate over a wide range of length-scales. Specifically, we compare the mechanical properties of two groups of humeri from healthy beagles, one control group comprising eight females (oral doses of saline vehicle, 1 mL/kg/day, 3 years) and one treated group comprising nine females (oral doses of alendronate used to treat osteoporosis, 0.2mg/kg/day, 3 years). Our data demonstrate treatment-specific reorganization of bone tissue identified at multiple length-scales mainly through advanced synchrotron x-ray experiments. We confirm that bisphosphonate treatments can increase non-enzymatic collagen cross-linking at molecular scales, which critically restricts plasticity associated with fibrillar sliding, and hence intrinsic toughening, at nanoscales. We also observe changes in the intracortical architecture of treated bone at microscales, with partial filling of the Haversian canals and reduction of osteon number. We hypothesize that the reduced plasticity associated with BP treatments may induce an increase in microcrack accumulation and growth under cyclic daily loadings, and potentially increase the susceptibility of cortical bone to atypical (fatigue-like) fractures. Published by Elsevier Inc.

  13. Fracture resistance exhibited by endodontically treated and retreated teeth shaped by ProTaper NEXT versus WaveOne: An in vitro study

    PubMed Central

    Khalap, Neha Deepak; Hegde, Vibha; Kokate, Sharad

    2015-01-01

    Aim: To compare the fracture resistance exhibited by teeth after primary endodontic treatment and retreatment. Materials and Methods: One hundred freshly extracted human teeth were selected. 20 samples served as control (untreated). Eighty experimental samples were divided into two groups (n = 40) for instrumentation using rotary Protaper NEXT (PTN) or reciprocating WaveOne (WO) files and obturated using warm lateral compaction. Half of the samples (n = 20) from each group were subjected to a load. The remaining half were subjected to retreatment using Protaper universal retreatment files (RFs) followed by a file larger than the master apical file used in groups 1 and 2 and reobturated. Group A: Control, Group B: PTN + obturation, Group C: WO + obturation, Group D: RF + PTN + obturation and Group E: RF + WO + obturation. The retreatment specimens were also subjected to load and the readings acquired were statistically analyzed. Result: When compared between the groups, control group exhibited the highest fracture resistance (P < 0.01). When multiple tests were performed, Group E exhibited significantly less fracture resistance (P < 0.01). Conclusion: Endodontic treatment and retreatment both results in lowering the fracture resistance of a tooth. PMID:26752838

  14. Fracture resistance exhibited by endodontically treated and retreated teeth shaped by ProTaper NEXT versus WaveOne: An in vitro study.

    PubMed

    Khalap, Neha Deepak; Hegde, Vibha; Kokate, Sharad

    2015-01-01

    To compare the fracture resistance exhibited by teeth after primary endodontic treatment and retreatment. One hundred freshly extracted human teeth were selected. 20 samples served as control (untreated). Eighty experimental samples were divided into two groups (n = 40) for instrumentation using rotary Protaper NEXT (PTN) or reciprocating WaveOne (WO) files and obturated using warm lateral compaction. Half of the samples (n = 20) from each group were subjected to a load. The remaining half were subjected to retreatment using Protaper universal retreatment files (RFs) followed by a file larger than the master apical file used in groups 1 and 2 and reobturated. Group A: Control, Group B: PTN + obturation, Group C: WO + obturation, Group D: RF + PTN + obturation and Group E: RF + WO + obturation. The retreatment specimens were also subjected to load and the readings acquired were statistically analyzed. When compared between the groups, control group exhibited the highest fracture resistance (P < 0.01). When multiple tests were performed, Group E exhibited significantly less fracture resistance (P < 0.01). Endodontic treatment and retreatment both results in lowering the fracture resistance of a tooth.

  15. Musculoskeletal system pain and related factors in mothers of children with cerebral palsy.

    PubMed

    Terzi, Rabia; Tan, Gülten

    2016-01-01

    The aim of the present study was to identify prevalence of musculoskeletal system diseases and related factors among mothers of children with cerebral palsy. Eighty-five mothers of children with cerebral palsy were included as the treatment group, and 42 mothers of healthy children were included as the control group. Sociodemographic characteristics of all subjects were recorded. Musculoskeletal system pain was evaluated by the standardized Nordic Musculoskeletal Questionnaire, and level of depression was evaluated according to Beck's Depression Scale. Musculoskeletal system pain and depression scores of the treatment group were significantly higher than those of the control group. Most frequently reported by mothers in the treatment group was low back pain (44.7%). In multiple regression analysis, number of children, age, and functional level of the child with cerebral palsy, as well as depression level of the mother were identified as independent risk factors for musculoskeletal system pain. Mothers of children with cerebral palsy are at higher risk for musculoskeletal system pain and depression. Prevalence of musculoskeletal system pain in these mothers, especially those with older children who have lower functional statuses, should be kept in mind.

  16. Predictors of improvement in subjective sleep quality reported by older adults following group-based cognitive behavior therapy for sleep maintenance and early morning awakening insomnia.

    PubMed

    Lovato, Nicole; Lack, Leon; Wright, Helen; Kennaway, David J

    2013-09-01

    Cognitive behavior therapy is an effective nonpharmacologic treatment for insomnia. However, individualized administration is costly and often results in substantial variability in treatment response across individual patients, particularly so for older adults. Group-based administration has demonstrated impressive potential for a brief and inexpensive answer to the effective treatment of insomnia in the older population. It is important to identify potential predictors of response to such a treatment format to guide clinicians when selecting the most suitable treatment for their patients. The aim of our study was to identify factors that predict subjective sleep quality of older adults following group-based administration of cognitive behavior therapy for insomnia (CBT-I). Eighty-six adults (41 men; mean age, 64.10 y; standard deviation [SD], 6.80) with sleep maintenance or early morning awakening insomnia were selected from a community-based sample to participate in a 4-week group-based treatment program of CBT-I. Participants were required to complete 7-day sleep diaries and a comprehensive battery of questionnaires related to sleep quality and daytime functioning. Hierarchical multiple regression analyses were used to identify factors predicting subjective sleep quality immediately following treatment and at 3-month follow-up. Sleep diaries reported average nightly sleep efficiency (SE), which was used as the outcome measure of sleep quality. Participants with the greatest SE following treatment while controlling for pretreatment SE were relatively younger and had more confidence in their ability to sleep at pretreatment. These characteristics may be useful to guide clinicians when considering the use of a group-based CBT-I for sleep maintenance or early morning awakening insomnia in older adults. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. Factors that lessen the burden of treatment in complex patients with chronic conditions: a qualitative study.

    PubMed

    Ridgeway, Jennifer L; Egginton, Jason S; Tiedje, Kristina; Linzer, Mark; Boehm, Deborah; Poplau, Sara; de Oliveira, Djenane Ramalho; Odell, Laura; Montori, Victor M; Eton, David T

    2014-01-01

    Patients with multiple chronic conditions (multimorbidity) often require ongoing treatment and complex self-care. This workload and its impact on patient functioning and well-being are, together, known as treatment burden. This study reports on factors that patients with multimorbidity draw on to lessen perceptions of treatment burden. Interviews (n=50) and focus groups (n=4 groups, five to eight participants per group) were conducted with patients receiving care in a large academic medical center or an urban safety-net hospital. Interview data were analyzed using qualitative framework analysis methods, and themes and subthemes were used to identify factors that mitigate burden. Focus groups were held to confirm these findings and clarify any new issues. This study was part of a larger program to develop a patient-reported measure of treatment burden. Five major themes emerged from the interview data. These included: 1) problem-focused strategies, like routinizing self-care, enlisting support of others, planning for the future, and using technology; 2) emotion-focused coping strategies, like maintaining a positive attitude, focusing on other life priorities, and spirituality/faith; 3) questioning the notion of treatment burden as a function of adapting to self-care and comparing oneself to others; 4) social support (informational, tangible, and emotional assistance); and 5) positive aspects of health care, like coordination of care and beneficial relationships with providers. Additional subthemes arising from focus groups included preserving autonomy/independence and being proactive with providers. Patients attempt to lessen the experience of treatment burden using a variety of personal, social, and health care resources. Assessing these factors in tandem with patient perceptions of treatment burden can provide a more complete picture of how patients fit complex self-care into their daily lives.

  18. Immune response genes receptors expression and polymorphisms in relation to multiple sclerosis susceptibility and response to INF-β therapy.

    PubMed

    Karam, Rehab A; Rezk, Noha A; Amer, Mona M; Fathy, Hala A

    2016-09-01

    Interferon (IFN)-β is one of the disease modifying drugs used in the treatment of multiple sclerosis. A predictive marker that indicates good or poor response to the treatment is highly desirable. We aimed to investigate the relation between the immune response genes receptors (IFNAR1, IFNAR2, and CCR5) expression and their polymorhic variants and multiple sclerosis (MS) susceptibility as well as the response to IFN-β therapy. The immune response genes receptors expression and genotyping were analyzed in 80 patients with MS, treated with IFN-β and in 110 healthy controls. There was a significant decrease of IFNAR1 and IFNAR2 mRNA expression and a significant increase of CCR5 mRNA expression in MS patients compared with the control group. Also, the level of IFNAR1, IFNAR2, and CCR5 mRNA expression was found to be significantly lower in the responders than nonresponders. Carriers of IFNAR1 18417 C/C genotype and C allele had an increased risk of developing MS. There was a significant relation between CCR5 Δ32 allele and IFN-β treatment response in MS patients. Our results highlighted the significance of IFNAR and CCR5 genes in multiple sclerosis risk and the response to IFN-β therapy. © 2016 IUBMB Life, 68(9):727-734, 2016. © 2016 International Union of Biochemistry and Molecular Biology.

  19. Multiple attachments and group psychotherapy: implications for college counseling centers.

    PubMed

    Marmarosh, Cheri L

    2009-10-01

    A large body of literature has supported the application of attachment theory to the understanding of college student development and the process of individual psychotherapy. Despite group treatment being one of the major methods of intervention in college counseling centers, there has been very little research guided by attachment theory that has been applied to the area of group psychotherapy. Many current assessment instruments used in college counseling centers can be supported with attachment theory, and many group therapy interventions are aimed at facilitating secure working models of self, other, and groups. This paper explores the importance of personal and group attachments in group psychotherapy and specifically addresses implications for clinical training and research in university counseling centers.

  20. The food processing contaminant glyoxal promotes tumour growth in the multiple intestinal neoplasia (Min) mouse model.

    PubMed

    Svendsen, Camilla; Høie, Anja Hortemo; Alexander, Jan; Murkovic, Michael; Husøy, Trine

    2016-08-01

    Glyoxal is formed endogenously and at a higher rate in the case of hyperglycemia. Glyoxal is also a food processing contaminant and has been shown to be mutagenic and genotoxic in vitro. The tumourigenic potential of glyoxal was investigated using the multiple intestinal neoplasia (Min) mouse model, which spontaneously develops intestinal tumours and is susceptible to intestinal carcinogens. C57BL/6J females were mated with Min males. Four days after mating and throughout gestation and lactation, the pregnant dams were exposed to glyoxal through drinking water (0.0125%, 0.025%, 0.05%, 0.1%) or regular tap water. Female and male offspring were housed separately from PND21 and continued with the same treatment. One group were only exposed to 0.1% glyoxal from postnatal day (PND) 21. There was no difference in the number of intestinal tumours between control and treatment groups. However, exposure to 0.1% glyoxal starting in utero and at PND21 caused a significant increase in tumour size in the small intestine for male and female mice in comparison with respective control groups. This study suggests that glyoxal has tumour growth promoting properties in the small intestine in Min mice. Copyright © 2016 Norwegian Institute of Public Health. Published by Elsevier Ltd.. All rights reserved.

  1. Determinants of complications after multiple transrectal core biopsies of the prostate.

    PubMed

    Norberg, M; Holmberg, L; Häggman, M; Magnusson, A

    1996-01-01

    Transrectal ultrasound-guided biopsies of the prostate were performed on 347 consecutive men. All patients were given prophylactic antibiotics. The first 199 patients received 400 mg norfloxacin immediately after the biopsies were performed and 400 mg the same evening. The second group of 148 patients received 400 mg of norfloxacin 1 h before the examination followed by five doses administered twice daily. A total of 15 major complications were noted. In the first group the complication rate was 6.5% and in the second group 1.4%. The different regimes of prophylactic antibiotic treatment were the only parameters shown to have a statistically significant impact on the complication rate. The number of complications decreased, but were not eliminated, when prophylactic treatment with norfloxacin was given before the biopsies were taken and continued for a total of 3 days.

  2. The role of three-dimensional imaging in optimizing diagnosis, classification and surgical treatment of hepatocellular carcinoma with portal vein tumor thrombus.

    PubMed

    Wei, Xu-Biao; Xu, Jie; Li, Nan; Yu, Ying; Shi, Jie; Guo, Wei-Xing; Cheng, Hong-Yan; Wu, Meng-Chao; Lau, Wan-Yee; Cheng, Shu-Qun

    2016-03-01

    Accurate assessment of characteristics of tumor and portal vein tumor thrombus is crucial in the management of hepatocellular carcinoma. Comparison of the three-dimensional imaging with multiple-slice computed tomography in the diagnosis and treatment of hepatocellular carcinoma with portal vein tumor thrombus. Patients eligible for surgical resection were divided into the three-dimensional imaging group or the multiple-slice computed tomography group according to the type of preoperative assessment. The clinical data were collected and compared. 74 patients were enrolled into this study. The weighted κ values for comparison between the thrombus type based on preoperative evaluation and intraoperative findings were 0.87 for the three-dimensional reconstruction group (n = 31) and 0.78 for the control group (n = 43). Three-dimensional reconstruction was significantly associated with a higher rate of en-bloc resection of tumor and thrombus (P = 0.025). Using three-dimensional reconstruction, significant correlation existed between the predicted and actual volumes of the resected specimens (r = 0.82, P < 0.01), as well as the predicted and actual resection margins (r = 0.97, P < 0.01). Preoperative three-dimensional reconstruction significantly decreased tumor recurrence and tumor-related death, with hazard ratios of 0.49 (95% confidential interval, 0.27-0.90) and 0.41 (95% confidential interval, 0.21-0.78), respectively. For hepatocellular carcinoma with portal vein tumor thrombus, three-dimensional imaging was efficient in facilitating surgical treatment and benefiting postoperative survivals. Copyright © 2015 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  3. [Application of damage control concept in severe limbs fractures combining with multiple trauma].

    PubMed

    Bayin, Er-gu-le; Jin, Hong-bing; Li, Ming

    2015-09-01

    To discuss the application and clinical effect of damage control concept in the treatment of severe limbs fractures combining with multiple trauma. From July 2009 to July 2012, 30 patients with severe limbs fractures combining with multiple trauma were treated with the damage control concept, included 20 males and 10 females with an average age of (34.03 ± 12.81) years old ranging from 20 to 60 years old; the ISS averaged (35.00 ± 12.81) points (ranged from 26 to 54 points). And the control group also contained 30 patients with severe limbs fractures combining with multiple trauma treated by the traditional operation from June 2006 to June 2009, there were 23 males and 7 females with an average age of (34.23 ± 11.04) years old ranging from 18 to 65 years old. The ISS averaged (35.56 ± 11.04) points (ranged from 26 to 51 points). The age, gender, ISS, Gustilo classification, operation time, intraoperative blood loss, blood transfusion,postoperative complications and mortality rate were observed and compared. In the damage control concept group,there were 28 cases surviving and 2 cases (6.7%) death; 6 cases of postoperative complication included 2 cases of adult respiratory distress syndrome, 1 case of multiple organ failure, 1 case of disseminated intravascular coagulation and 2 cases of wound infection. In the control group, there were 22 cases surviving and 8 cases death(26.7%); 13 cases of postoperative complication included 4 cases of adult respiratory distress syndrome,2 cases of multiple organ failure, 2 cases of disseminated intravascular coagulation and 3 cases of wound infection. There were no statistically significant differences between two groups in age, gender, ISS, Gustilo classfication and complication (P > 0.05), however there were statistically significant differences in mortality rate, operation time, blodd loss, blodd transfusion between two groups (P < 0.05). Damage control concept is used to treat severe limbs fractures combining with multiple trauma which has the rapid and effective therapy, can improve survival rate and reduce complication.

  4. Multiple behavior changes in diet and activity: a randomized controlled trial using mobile technology.

    PubMed

    Spring, Bonnie; Schneider, Kristin; McFadden, H Gene; Vaughn, Jocelyn; Kozak, Andrea T; Smith, Malaina; Moller, Arlen C; Epstein, Leonard H; Demott, Andrew; Hedeker, Donald; Siddique, Juned; Lloyd-Jones, Donald M

    2012-05-28

    Many patients exhibit multiple chronic disease risk behaviors. Research provides little information about advice that can maximize simultaneous health behavior changes. To test which combination of diet and activity advice maximizes healthy change, we randomized 204 adults with elevated saturated fat and low fruit and vegetable intake, high sedentary leisure time, and low physical activity to 1 of 4 treatments: increase fruit/vegetable intake and physical activity, decrease fat and sedentary leisure, decrease fat and increase physical activity, and increase fruit/vegetable intake and decrease sedentary leisure. Treatments provided 3 weeks of remote coaching supported by mobile decision support technology and financial incentives. During treatment, incentives were contingent on using the mobile device to self-monitor and attain behavioral targets; during follow-up, incentives were contingent only on recording. The outcome was standardized, composite improvement on the 4 diet and activity behaviors at the end of treatment and at 5-month follow-up. Of the 204 individuals randomized, 200 (98.0%) completed follow-up. The increase fruits/vegetables and decrease sedentary leisure treatments improved more than the other 3 treatments (P < .001). Specifically, daily fruit/vegetable intake increased from 1.2 servings to 5.5 servings, sedentary leisure decreased from 219.2 minutes to 89.3 minutes, and saturated fat decreased from 12.0% to 9.5% of calories consumed. Differences between treatment groups were maintained through follow-up. Traditional dieting (decrease fat and increase physical activity) improved less than the other 3 treatments (P < .001). Remote coaching supported by mobile technology and financial incentives holds promise to improve diet and activity. Targeting fruits/vegetables and sedentary leisure together maximizes overall adoption and maintenance of multiple healthy behavior changes.

  5. Multiple Behavior Change in Diet and Activity: A Randomized Controlled Trial Using Mobile Technology

    PubMed Central

    Spring, Bonnie; Schneider, Kristin; McFadden, H.G.; Vaughn, Jocelyn; Kozak, Andrea T.; Smith, Malaina; Moller, Arlen C.; Epstein, Leonard H.; DeMott, Andrew; Hedeker, Donald; Siddique, Juned; Lloyd-Jones, Donald M.

    2012-01-01

    Background Many patients exhibit multiple chronic disease risk behaviors. Research provides little information about advice that can maximize simultaneous health behavior changes. Methods To test which combination of diet and activity advice maximizes healthy change, we randomized 204 adults with elevated saturated fat and low fruit/vegetable intakes, high sedentary leisure time and low physical activity to one of four treatments: increase fruit/vegetable and physical activity; decrease fat and sedentary leisure; decrease fat and increase physical activity; increase fruit/vegetable and decrease sedentary leisure. Treatments provided three weeks of remote coaching supported by mobile decision support technology and financial incentives. During treatment, incentives were contingent on using the mobile device to self-monitor and attain behavioral targets; during follow-up they were contingent only on recording. The outcome was standardized, composite improvement on the four diet and activity behaviors at end of treatment and five month follow-up. Results Of those randomized, 200 (98%) completed follow-up. The increase fruit/vegetable and decrease sedentary leisure treatment improved more than the other 3 treatments (p<.001). Specifically, fruit/vegetables increased from 1.2 servings/day to 5.5; sedentary leisure decreased from 219.2 minutes/day to 89.3; saturated fat decreased from 12.0% of calories consumed to 9.5%. Differences between treatment groups were maintained through follow-up. Traditional dieting (decrease fat and increase physical activity) improved less than the other 3 treatments (p<.001). Conclusions Remote coaching supported by mobile technology and financial incentives holds promise to improve diet and activity. Targeting fruits/vegetables and sedentary leisure together maximizes overall adoption and maintenance of multiple healthy behavior changes. PMID:22636824

  6. [The multiple social roles of female lay caretakers of hospitalized children].

    PubMed

    Wegner, Wiliam; Pedro, Eva Neri Rubim

    2010-06-01

    This is a qualitative, descriptive, exploratory, and interventionist research carried out with nine female lay caretakers of children undergoing oncologic treatment. The objectives were to present the multiple social roles performed by female lay caretakers of children with cancer and to discuss the caretaker's role in society. The study was carried out between March and April, 2007, at Hospital de Clinicas de Porto Alegre, Rio Grande do Sul, Brazil. The data collection was performed with the focal group technique. The results were examined through the analysis of thematic content, which evidenced the multiple social roles performed by women, the main group of caretakers in society, regardless of the context. Final considerations enhance a discussion in the educational, political and social levels about the redistribution of social roles, particularly family responsibility between men and women. The participation of the nursing staff can take place through the comprehension of those roles imposed by the context and facilitate family inclusion in the care relationship.

  7. The utilization of unified protocols in behavioral cognitive therapy in transdiagnostic group subjects: A clinical trial.

    PubMed

    de Ornelas Maia, Ana Claudia Corrêa; Nardi, Antonio Egidio; Cardoso, Adriana

    2015-02-01

    The practicing of protocols based on behavioral cognitive therapy (CBT) have been frequently used in the last decades and adapted to better manage the necessities of patients and providers. The goal is to build a treatment that is evidence-based - for that reason the unified protocol for multiple emotional disorders (transdiagnostics) have been utilized to simplify treatment - without losing scientific traits. The main goal of this study is to evaluate the unified protocol in groups of patients with depression and anxiety disorders. In a pool of 48 subjects, divided in two groups, one was submitted to 12 intervention sessions of the unified protocol while the other was solely given medication. MINI, BAI and BDI were the instruments used at the beginning and at the end of treatment. The results were highly significant (p<0.001) in as much as with the improvement of anxiety and depressive disorders as it was in the group which was treated with the unified protocol compared with the group which was only given medication Limitations of this study were the number of sample participants and the non-randomization of subjects in both groups. Group therapy has not been largely implemented though it is deemed very useful for treatments when the unified protocol is used in transdiagnostic patients. Not only does it allow for emotional stabilizing and socialization but it also enables subjects with an altruistic feeling amongst themselves. Copyright © 2014 Elsevier B.V. All rights reserved.

  8. Chemical Isotope Labeling LC-MS for Monitoring Disease Progression and Treatment in Animal Models: Plasma Metabolomics Study of Osteoarthritis Rat Model

    NASA Astrophysics Data System (ADS)

    Chen, Deying; Su, Xiaoling; Wang, Nan; Li, Yunong; Yin, Hua; Li, Liang; Li, Lanjuan

    2017-01-01

    We report a chemical isotope labeling (CIL) liquid chromatography mass spectrometry (LC-MS) method generally applicable for tracking metabolomic changes from samples collected in an animal model for studying disease development and treatment. A rat model of surgically induced osteoarthritis (OA) was used as an example to illustrate the workflow and technical performance. Experimental duplicate analyses of 234 plasma samples were carried out using dansylation labeling LC-MS targeting the amine/phenol submetabolome. These samples composed of 39 groups (6 rats per group) were collected at multiple time points with sham operation, OA control group, and OA rats with treatment, separately, using glucosamine/Celecoxib and three traditional Chinese medicines (Epimedii folium, Chuanxiong Rhizoma and Bushen-Huoxue). In total, 3893 metabolites could be detected and 2923 of them were consistently detected in more than 50% of the runs. This high-coverage submetabolome dataset could be used to track OA progression and treatment. Many differentiating metabolites were found and 11 metabolites including 2-aminoadipic acid, saccharopine and GABA were selected as potential biomarkers of OA progression and OA treatment. This study illustrates that CIL LC-MS is a very useful technique for monitoring incremental metabolomic changes with high coverage and accuracy for studying disease progression and treatment in animal models.

  9. Chemical Isotope Labeling LC-MS for Monitoring Disease Progression and Treatment in Animal Models: Plasma Metabolomics Study of Osteoarthritis Rat Model

    PubMed Central

    Chen, Deying; Su, Xiaoling; Wang, Nan; Li, Yunong; Yin, Hua; Li, Liang; Li, Lanjuan

    2017-01-01

    We report a chemical isotope labeling (CIL) liquid chromatography mass spectrometry (LC-MS) method generally applicable for tracking metabolomic changes from samples collected in an animal model for studying disease development and treatment. A rat model of surgically induced osteoarthritis (OA) was used as an example to illustrate the workflow and technical performance. Experimental duplicate analyses of 234 plasma samples were carried out using dansylation labeling LC-MS targeting the amine/phenol submetabolome. These samples composed of 39 groups (6 rats per group) were collected at multiple time points with sham operation, OA control group, and OA rats with treatment, separately, using glucosamine/Celecoxib and three traditional Chinese medicines (Epimedii folium, Chuanxiong Rhizoma and Bushen-Huoxue). In total, 3893 metabolites could be detected and 2923 of them were consistently detected in more than 50% of the runs. This high-coverage submetabolome dataset could be used to track OA progression and treatment. Many differentiating metabolites were found and 11 metabolites including 2-aminoadipic acid, saccharopine and GABA were selected as potential biomarkers of OA progression and OA treatment. This study illustrates that CIL LC-MS is a very useful technique for monitoring incremental metabolomic changes with high coverage and accuracy for studying disease progression and treatment in animal models. PMID:28091618

  10. Influence of Hot-Etching Surface Treatment on Zirconia/Resin Shear Bond Strength

    PubMed Central

    Lv, Pin; Yang, Xin; Jiang, Ting

    2015-01-01

    This study was designed to evaluate the effect of hot-etching surface treatment on the shear bond strength between zirconia ceramics and two commercial resin cements. Ceramic cylinders (120 units; length: 2.5 mm; diameter: 4.7 mm) were randomly divided into 12 groups (n = 10) according to different surface treatments (blank control; airborne-particle-abrasion; hot-etching) and different resin cements (Panavia F2.0; Superbond C and B) and whether or not a thermal cycling fatigue test (5°–55° for 5000 cycles) was performed. Flat enamel surfaces, mounted in acrylic resin, were bonded to the zirconia discs (diameter: 4.7 mm). All specimens were subjected to shear bond strength testing using a universal testing machine with a crosshead speed of 1 mm/min. All data were statistically analyzed using one-way analysis of variance and multiple-comparison least significant difference tests (α = 0.05). Hot-etching treatment produced higher bond strengths than the other treatment with both resin cements. The shear bond strength of all groups significantly decreased after the thermal cycling test; except for the hot-etching group that was cemented with Panavia F2.0 (p < 0.05). Surface treatment of zirconia with hot-etching solution enhanced the surface roughness and bond strength between the zirconia and the resin cement. PMID:28793699

  11. Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

    PubMed

    McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

    2017-10-01

    The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

  12. Proteasome 20S in multiple myeloma: comparison of concentration and chymotrypsin-like activity in plasma and serum.

    PubMed

    Romaniuk, Wioletta; Kalita, Joanna; Ostrowska, Halina; Kloczko, Janusz

    2018-03-05

    The ubiquitin-proteasome system is relevant in the pathobiology of many haematological malignancies, including multiple myeloma. The assessment of proteasome concentration and chymotrypsin-like (ChT-L) activity might constitute a new approach to diagnosis, prognosis and monitoring of anticancer treatment of patients with haematological malignancies and other diseases. The aim of our study was to determine which material, plasma or serum, is better for measuring chymotrypsin-like (ChT-L) activity and proteasome concentration. We analysed proteasome concentration and chymotrypsin-like (ChT-L) activity in 70 plasma and serum samples drawn from 28 patients at different treatment stages for multiple myeloma (MM) and 31 healthy volunteers. Proteasome ChT-L activity and concentration in multiple myeloma patients were significantly higher in plasma compared to serum. In this group we observed significant and positive correlations both between the plasma and serum proteasome ChT-L activity and plasma and serum proteasome concentration. The higher values of proteasome concentration and ChT-L activity in plasma than in serum and their better correlations with parameters of tumour load and prognosis suggest that plasma constitutes a better biological material for measuring ChT-L activity and proteasome concentration than serum in multiple myeloma patients.

  13. Multiple forms of rhythmic movements in an adolescent boy with rhythmic movement disorder.

    PubMed

    Su, Changjun; Miao, Jianting; Liu, Yu; Liu, Rui; Lei, Gesheng; Zhang, Wei; Yang, Ting; Li, Zhuyi

    2009-12-01

    Rhythmic movement disorder (RMD) refers to a group of stereotyped, repetitive movements involving large muscles, usually occurring prior to the onset of sleep and persisting into sleep. RMD more commonly exhibits only one or two forms of rhythmic movements (RM) in most reported cases. However, multiple RM forms of RMD occurring in a patient in the same night have rarely been reported. In this report, we present the unique case of a 15-year-old boy with RMD affected by multiple forms of RM in the same night, including four known forms (i.e., body rocking, head banging, leg rolling, and rhythmic feet movements) and two new kinds of RM (bilateral rhythmic arm rocking and rhythmic hands movements). Two video-polysomnographic recordings were performed in this patient before starting pharmacologic treatment and after long-term oral clonazepam treatment (1.0mg nightly for 3 months). The characteristics of RMD with multiple RM forms and the effectiveness of clonazepam on the RM episodes and polysomnographic findings observed in our patient are discussed. This report raises the fact that a patient with RMD may present with multiple complex rhythmic movements disrupting sleep, which emphasizes that better understanding of the clinical features of complex rhythmic movements during sleep in primary care settings is essential for early clinical diagnosis and optimal management.

  14. Phase 3 randomised study of the proposed biosimilar adalimumab GP2017 in psoriasis - impact of multiple switches.

    PubMed

    Blauvelt, A; Lacour, J-P; Fowler, J F; Weinberg, J M; Gospodinov, D; Schuck, E; Jauch-Lembach, J; Balfour, A; Leonardi, C L

    2018-06-19

    The impact of multiple switches between GP2017 and reference adalimumab (ref-ADMB) was assessed following the demonstration of equivalent efficacy and similar safety and immunogenicity, in adult patients with active, clinically stable, moderate-to-severe plaque psoriasis. This 51-week double-blinded, phase 3 study randomly assigned patients to GP2017 (N=231) or ref-ADMB (N=234) 80 mg subcutaneously at Week 0, then 40 mg biweekly from Week 1. At Week 17, patients were re-randomised to switch (n=126) or continue (n=253) treatment. Primary endpoint: patients achieving Psoriasis Area and Severity Index (PASI)75 at Week 16 (equivalence confirmed if the 95% confidence interval [CI] for the difference in PASI75 between treatments was ±18%). Key secondary endpoint: change from baseline to Week 16 in continuous PASI. Other endpoints: PASI over time, PASI 50/75/90/100, pharmacokinetics, safety, tolerability and immunogenicity for the switched and continued treatment groups. Equivalent efficacy between GP2017 and ref-ADMB was confirmed for the primary (66.8% and 65.0%, respectively; 95% CI, -7.46, 11.15) and key secondary (-60.7% and -61.5%, respectively; 95% CI, -3.15, 4.84) endpoints. PASI improved over time and was similar between treatment groups at Week 16, and the switched/continued groups from Weeks 17-51. There were no relevant safety or immunogenicity differences between GP2017 and ref-ADMB at Week 16, or the switched/continued groups from Weeks 17-51. No hypersensitivity to adalimumab was reported upon switching. Following the demonstration of GP2017 biosimilarity to ref-ADMB, switching up to four times between GP2017 and ref-ADMB had no detectable impact on efficacy, safety or immunogenicity. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  15. Initial implementation and evaluation of a Hepatitis C treatment clinical decision support system (CDSS)

    PubMed Central

    Fathauer, L; Meek, J.

    2012-01-01

    Background Clinician compliance with clinical guidelines in the treatment of patients with Hepatitis C (HCV) has been reported to be as low as 18.5%. Treatment is complex and patient compliance is often inconsistent thus, active clinician surveillance and support is essential to successful outcomes. A clinical decision support system (CDSS) embedded within an electronic health record can provide reminders, summarize key data, and facilitate coordination of care. To date, the literature is bereft of information describing the implementation and evaluation of a CDSS to support HCV treatment. Objective The purpose of this case report is to describe the design, implementation, and initial evaluation of an HCV-specific CDSS while piloting data collection metrics and methods to be used in a larger study across multiple practices. Methods The case report describes the design and implementation processes with preliminary reporting on impact of the CDSS on quality indicator completion by comparing the pre-CDSS group to the post-CDSS group. Results The CDSS was successfully designed and implemented using an iterative, collaborative process. Pilot testing of the clinical outcomes of the CDSS revealed high rates of quality indicator completion in both the pre- and post-CDSS; although the post-CDSS group received a higher frequency of reminders (4.25 per patient) than the pre-CDSS group (.25 per patient). Conclusions This case report documents the processes used to successfully design and implement an HCV CDSS. While the small sample size precludes generalizability of findings, results did positively demonstrate the feasibility of comparing quality indicator completion rates pre-CDSS and post-CDSS. It is recommended that future studies include a larger sample size across multiple providers with expanded outcomes measures related to patient outcomes, staff satisfaction with the CDSS, and time studies to evaluate efficiency and cost effectiveness of the CDSS. PMID:23646082

  16. How to determine bortezomib-based regimen for elderly patients with multiple myeloma: PAD versus CBd, an observational study.

    PubMed

    Huang, Bin-Tao; Tan, Yan; Zhao, Wei-Hong; Zeng, Qing-Chun; Li, Bing-Sheng; Chen, Rui-Lin

    2014-02-01

    This was an open-label, observational, prospective assessment. We conducted an analysis of the impact of bortezomib-based therapy (PAD: bortezomib, doxorubicin, high-dose dexamethasone vs. CBd: cyclophosphamide bortezomib, low-dose dexamethasone) on the survival rates and adverse events in elderly patients with newly diagnosed multiple myeloma (MM). Out of 303 patients, 128 received the PAD regimen and the other 175 patients received the CBd induction therapy (age 65-89 years). Baseline patient characteristics between the two cohorts were balanced in age (P = 0.69), international staging system (ISS) prognostic stages (P = 0.90), serum calcium (P = 0.70), and serum creatinine (P = 0.52). Overall response (OS) after the induction chemotherapy was achieved in 214 of 303 patients (70.6 %), with no significant differences observed between the two treatment groups (71.9 vs. 69.7 %, P = 0.68). Patients with ISS stage 2 reached the same 5-year OS advantages compared to patients with ISS stage 1, because they received bortezomib-based PAD or CBd treatments. Patients receiving CBd protocol gained similar satisfactory progression-free survival (PFS) results when compared to the PAD regimen group: PFS at 5 years reached 58.2 versus 58.9 % (P = 0.85). Five-year OS in the CBd arm had significant advantages compared to the PAD group, 79.9 versus 49.9 % (P < 0.05). The overall safety profiles showed that 26 of 128 (20.3 %) patients died in the PAD arm, while 13 of 175 patients died (7.4 %) in the CBd group (P < 0.01). Similarly, the PAD arm had a higher serious infection rate than that of the CBd arm (39.2 vs. 13.1 %, P < 0.01). Bortezomib benefits elderly patients with newly diagnosed MM; they achieve satisfactory treatment responses and survival advantages. Further, patients treated with CBd have superior treatment advantages, with a predictable safety profile, when compared to the PAD regimen.

  17. The Long-Term Impact of Neurofeedback on Symptom Burden and Interference in Patients With Chronic Chemotherapy-Induced Neuropathy: Analysis of a Randomized Controlled Trial.

    PubMed

    Prinsloo, Sarah; Novy, Diane; Driver, Larry; Lyle, Randall; Ramondetta, Lois; Eng, Cathy; Lopez, Gabriel; Li, Yisheng; Cohen, Lorenzo

    2018-05-01

    Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment and may adversely affect quality of life (QOL) for years. We explored the long-term effects of electroencephalographic neurofeedback (NFB) as a treatment for CIPN and other aspects of QOL. Seventy-one cancer survivors (mean age 62.5; 87% females) with CIPN were randomized to NFB or to a waitlist control (WLC) group. The NFB group underwent 20 sessions of NFB where rewards were given for voluntary changes in electroencephalography. Measurements of pain, cancer-related symptoms, QOL, sleep, and fatigue were obtained at baseline, end of treatment, and one and four months later. Seventy one participants enrolled in the study. At the end of treatment, 30 in the NFB group and 32 in the WLC group completed assessments; at four months, 23 in the NFB group and 28 in the WLC completed assessments. Linear mixed model analysis revealed significant group × time interaction for pain severity. A general linear model determined that the NFB group had greater improvements in worst pain (primary outcome) and other symptoms such as numbness, cancer-related symptom severity, symptom interference, physical functioning, general health, and fatigue compared with the WLC group at the end of treatment and four months (all P < 0.05). Effect sizes were moderate or large for most measures. NFB appears to result in long-term reduction in multiple CIPN symptoms and improved postchemotherapy QOL and fatigue. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  18. Combined retrograde flexible ureteroscopic lithotripsy with holmium YAG laser for renal calculi associated with ipsilateral ureteral stones.

    PubMed

    Cocuzza, Marcello; Colombo, Jose R; Ganpule, Arvind; Turna, Burak; Cocuzza, Antonio; Dhawan, Divyar; Santos, Bruno; Mazzucchi, Eduardo; Srougi, Miguel; Desai, Mahesh; Desai, Mihir

    2009-02-01

    The purpose of this study was to evaluate the effectiveness of combined ureteroscopic holmium YAG lithotripsy for renal calculi associated with ipsilateral ureteral stones. Between August 2002 and March 2007, retrograde flexible ureteroscopic stone treatment was attempted in 351 cases. Indication for treatment was concurrent symptomatic ureteral stones in 63 patients (group I). Additional operative time and perioperative complication rates were compared to a group of 39 patients submitted to ureteroscopic treatment for ureteral calculi exclusively (group II). Mean ureteral stone size was 8.0 +/- 2.6 mm and 8.1 +/- 3.4 mm for groups I and II, respectively. Mean operative time for group I was 67.9 +/- 29.5 minutes and for group 2 was 49.3 +/- 13.2 minutes (p < 0.001). Flexible ureteroscopic therapy for renal calculi increased 18 minutes in the mean operative time. The overall complication rate was 3.1% and 2.5% for groups I and II, respectively (p = 0.87). Mean renal stone size was 10.7 +/- 6.4 mm, overall stone free rate in group I was 81%. However, considering only patients with renal stones smaller than 15 mm, the stone free rate was 88%. Successful treatment occurred in 81% of patients presenting lower pole stones, but only 76% of patients with multiple renal stones became stone free. As expected, stone free rate showed a significant negative correlation with renal stone size (p = 0.03; r = -0.36). Logistic regression model indicated an independent association of renal stones smaller than 15 mm and stone free rate (OR = 13.5; p = 0.01). Combined ureteroscopic treatment for ureteral and ipsilateral renal calculi is a safe and attractive option for patients presenting for symptomatic ureteral stone and ipsilateral renal calculi smaller than 15 mm.

  19. A comparison the effects of reflexology and relaxation on the psychological symptoms in women with multiple sclerosis

    PubMed Central

    Soheili, Mozhgan; Nazari, Fatemeh; Shaygannejad, Vahid; Valiani, Mahboobeh

    2017-01-01

    Background: Multiple sclerosis (MS) occurs with a variety of physical and psychological symptoms, yet there is not a conclusive cure for this disease. Complementary medicine is a current treatment which seems is effective in relieving symptoms of patients with MS. Therefore, this study is aimed to determine and compare the effects of reflexology and relaxation on anxiety, stress, and depression in women with MS. Subjects and Methods: This study is a randomized clinical trial that is done on 75 women with MS referred to MS Clinic of Kashani Hospital. After simple non random sampling, participants were randomly assigned by minimization method to three groups: reflexology, relaxation and control (25 patients in each group). In the experimental groups were performed reflexology and relaxation interventions within 4 weeks, twice a week for 40 min and the control group were received only routine treatment as directed by a doctor. Data were collected through depression anxiety and stress scale questionnaire, before, immediately after and 2 months after interventions in all three groups. Chi-square, Kruskal–Wallis, repeated measures analysis of variance and one-way analysis of variance and least significant difference post hoc test via SPSS version 18 were used to analyze the data (P < 0.05) was considered as significant level. Results: The results showed a significant reduction in the severity of anxiety, stress and depression during the different times in the reflexology and relaxation groups as compared with the control group (P < 0.05). Conclusion: The results showed that reflexology and relaxation in relieving anxiety, stress and depression are effective in women with MS. Hence, these two methods, as effective techniques, can be recommended. PMID:28546976

  20. A comparison the effects of reflexology and relaxation on the psychological symptoms in women with multiple sclerosis.

    PubMed

    Soheili, Mozhgan; Nazari, Fatemeh; Shaygannejad, Vahid; Valiani, Mahboobeh

    2017-01-01

    Multiple sclerosis (MS) occurs with a variety of physical and psychological symptoms, yet there is not a conclusive cure for this disease. Complementary medicine is a current treatment which seems is effective in relieving symptoms of patients with MS. Therefore, this study is aimed to determine and compare the effects of reflexology and relaxation on anxiety, stress, and depression in women with MS. This study is a randomized clinical trial that is done on 75 women with MS referred to MS Clinic of Kashani Hospital. After simple non random sampling, participants were randomly assigned by minimization method to three groups: reflexology, relaxation and control (25 patients in each group). In the experimental groups were performed reflexology and relaxation interventions within 4 weeks, twice a week for 40 min and the control group were received only routine treatment as directed by a doctor. Data were collected through depression anxiety and stress scale questionnaire, before, immediately after and 2 months after interventions in all three groups. Chi-square, Kruskal-Wallis, repeated measures analysis of variance and one-way analysis of variance and least significant difference post hoc test via SPSS version 18 were used to analyze the data ( P < 0.05) was considered as significant level. The results showed a significant reduction in the severity of anxiety, stress and depression during the different times in the reflexology and relaxation groups as compared with the control group ( P < 0.05). The results showed that reflexology and relaxation in relieving anxiety, stress and depression are effective in women with MS. Hence, these two methods, as effective techniques, can be recommended.

  1. New developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome.

    PubMed

    Pontari, Michel; Giusto, Laura

    2013-11-01

    To describe new developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CPPS). Symptoms in men with chronic prostatitis/CPPS appear to cluster into a group with primarily pelvic or localized disease, and a group with more systemic symptoms. Several other chronic pain conditions can be associated with chronic prostatitis/CPPS, including irritable bowel syndrome, fibromyalgia, and chronic fatigue syndrome. Markers of neurologic inflammation and autoimmune disease parallel changes in symptoms after treatment. Treatment options include new alpha-blockers, psychological intervention, and prostate-directed therapy. The areas of acupuncture and pelvic floor physical therapy/myofascial release have received increased recent attention and appear to be good options in these patients. Future therapy may include antibodies to mediators of neurogenic inflammation and even treatment of bacteria in the bowel. The diagnosis of chronic prostatitis/CPPS must include conditions traditionally outside the scope of urologic practice but important for the care of men with chronic pelvic pain. The treatment is best done using multiple simultaneous therapies aimed at the different aspects of the condition.

  2. The role of shock index as a predictor of multiple-trauma patients' pathways.

    PubMed

    Toccaceli, Andrea; Giampaoletti, Andrea; Dignani, Lucia; Lucertini, Carla; Petrucci, Cristina; Lancia, Loreto

    2016-03-01

    This research was conducted with the aim of investigating the accuracy of the shock index (SI) in distinguishing which multiple-trauma patients should be admitted to an intensive care unit (ICU) after treatment in an emergency room (ER). The SI is an easily obtained indicator, as it corresponds to an arithmetic ratio between the two parameters that are always measured during the first-aid treatment of multiple-trauma patients: heart rate (HR) and systolic blood pressure (SBP). There are many studies examining the SI in the multiple-trauma patients as a possible predictor of the destination unit. The SI is evaluated both at the trauma scene (pre-hospital SI-pH) and in the emergency room (SI-ER). An observational study with a retrospective approach was conducted on 158 adult patients with multiple trauma. The mean SI-pH and SI-ER values were higher in ICU patients than in-patients discharged or admitted to a normal ward, but the difference between these two patient groups was significant only for the SI-ER. Analysis of the receiver operating characteristic (ROC) curves confirmed that only the SI-ER is significant as a reliable indicator for ICU admission with a best cut-off of 1·05. However, a threshold value of 0·75 was still able to establish the correct type of destination for multiple-trauma patients, with a sensitivity of 57·3% and a specificity of 62·5%. This research showed that the SI-pH and SI-ER values are correlated, but only the SI-ER has shown statistical significance in terms of distinguishing the type of destination of multiple-trauma patient (ICU, ordinary ward or discharge) after initial treatment in the ER. The results of this study suggest the possibility of using SI in multiple-trauma patients as a triage indicator to assess the patients' care complexity and to guide the choice of proper clinical paths. © 2015 British Association of Critical Care Nurses.

  3. Beneficial effect of diosgenin as a stimulator of NGF on the brain with neuronal damage induced by Aβ-42 accumulation and neurotoxicant injection.

    PubMed

    Koh, Eun-Kyoung; Yun, Woo-Bin; Kim, Ji-Eun; Song, Sung-Hwa; Sung, Ji-Eun; Lee, Hyun-Ah; Seo, Eun-Ji; Jee, Seung-Wan; Bae, Chang-Joon; Hwang, Dae-Youn

    2016-06-01

    To investigate the beneficial effects of diosgenin (DG) on the multiple types of brain damage induced by Aβ-42 peptides and neurotoxicants, alterations in the specific aspects of brain functions were measured in trimethyltin (TMT)-injected transgenic 2576 (TG) mice that had been pretreated with DG for 21 days. Multiple types of damage were successfully induced by Aβ-42 accumulation and TMT injection into the brains of TG mice. However, DG treatment significantly reduced the number of Aβ-stained plaques and dead cells in the granule cells layer of the dentate gyrus. Significant suppression of acetylcholinesterase (AChE) activity and Bax/Bcl-2 expression was also observed in the DG treated TG mice (TG+DG group) when compared with those of the vehicle (VC) treated TG mice (TG+VC group). Additionally, the concentration of nerve growth factor (NGF) was dramatically enhanced in TG+DG group, although it was lower in the TG+VC group than the non-transgenic (nTG) group. Furthermore, the decreased phosphorylation of downstream members in the TrkA high affinity receptor signaling pathway in the TG+VC group was significantly recovered in the TG+DG group. A similar pattern was observed in p75(NTR) expression and JNK phosphorylation in the NGF low affinity receptor signaling pathway. Moreover, superoxide dismutase (SOD) activity was enhanced in the TG+DG group, while the level of malondialdehyde (MDA), a marker of lipid peroxidation, was lower in the TG+DG group than the TG+VC group. These results suggest that DG could exert a wide range of beneficial activities for multiple types of brain damage through stimulation of NGF biosynthesis.

  4. Beneficial effect of diosgenin as a stimulator of NGF on the brain with neuronal damage induced by Aβ-42 accumulation and neurotoxicant injection

    PubMed Central

    Koh, Eun-Kyoung; Yun, Woo-Bin; Kim, Ji-Eun; Song, Sung-Hwa; Sung, Ji-Eun; Lee, Hyun-Ah; Seo, Eun-Ji; Jee, Seung-Wan

    2016-01-01

    To investigate the beneficial effects of diosgenin (DG) on the multiple types of brain damage induced by Aβ-42 peptides and neurotoxicants, alterations in the specific aspects of brain functions were measured in trimethyltin (TMT)-injected transgenic 2576 (TG) mice that had been pretreated with DG for 21 days. Multiple types of damage were successfully induced by Aβ-42 accumulation and TMT injection into the brains of TG mice. However, DG treatment significantly reduced the number of Aβ-stained plaques and dead cells in the granule cells layer of the dentate gyrus. Significant suppression of acetylcholinesterase (AChE) activity and Bax/Bcl-2 expression was also observed in the DG treated TG mice (TG+DG group) when compared with those of the vehicle (VC) treated TG mice (TG+VC group). Additionally, the concentration of nerve growth factor (NGF) was dramatically enhanced in TG+DG group, although it was lower in the TG+VC group than the non-transgenic (nTG) group. Furthermore, the decreased phosphorylation of downstream members in the TrkA high affinity receptor signaling pathway in the TG+VC group was significantly recovered in the TG+DG group. A similar pattern was observed in p75NTR expression and JNK phosphorylation in the NGF low affinity receptor signaling pathway. Moreover, superoxide dismutase (SOD) activity was enhanced in the TG+DG group, while the level of malondialdehyde (MDA), a marker of lipid peroxidation, was lower in the TG+DG group than the TG+VC group. These results suggest that DG could exert a wide range of beneficial activities for multiple types of brain damage through stimulation of NGF biosynthesis. PMID:27382379

  5. Circulating IGF-1, IGFB-3, GH and TSH levels in multiple sclerosis and their relationship with treatment.

    PubMed

    Akcali, Aylin; Bal, Berrin; Erbagci, Binnur

    2017-07-01

    Improving the proficiency of oligodendrocytes in their ability to repair myelin damage is one of the major goals of multiple sclerosis treatment. Insulin-like growth factor-1 (IGF-1) is one of several polypeptides that are considered to have potential benefits in that sense. In the present study, we aimed to determine serum levels of IGF-1 and insulin-like growth factor binding protein-3 (IGFBP-3), thyroid stimulating hormone (TSH) and growth hormone (GH) among treated and non-treated patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and a healthy control group. The study enrolled 100 RRMS patients and 100 age- and sex-matched control subjects diagnosed with definite multiple sclerosis (MS). Serum GH, IGF-1, IGFBP-3, and TSH levels were studied. The number of relapses and Expanded Disability Status Scale were negatively correlated and IGFBP-3 and GH were positively correlated with IGF-1. A statistically significant difference was not observed when patients were divided into two subgroups as patients treated with a MS-specific therapy (n = 54) and non-treated patients (n = 46). TSH and IGFBP-3 values were significantly lower in patient group vs. While no difference was determined with in IGF-1 levels, low levels of IGF-1 was in correlation with the least levels of IGFBP-3. To understand the relation between IGF-1 and IGFBP-3, the role of low levels of IGFBP-3 and TSH may be studied with clinic isolated syndrome patients and the evolution of these patients to definite MS.

  6. The impact of multiple endpoint dependency on Q and I(2) in meta-analysis.

    PubMed

    Thompson, Christopher Glen; Becker, Betsy Jane

    2014-09-01

    A common assumption in meta-analysis is that effect sizes are independent. When correlated effect sizes are analyzed using traditional univariate techniques, this assumption is violated. This research assesses the impact of dependence arising from treatment-control studies with multiple endpoints on homogeneity measures Q and I(2) in scenarios using the unbiased standardized-mean-difference effect size. Univariate and multivariate meta-analysis methods are examined. Conditions included different overall outcome effects, study sample sizes, numbers of studies, between-outcomes correlations, dependency structures, and ways of computing the correlation. The univariate approach used typical fixed-effects analyses whereas the multivariate approach used generalized least-squares (GLS) estimates of a fixed-effects model, weighted by the inverse variance-covariance matrix. Increased dependence among effect sizes led to increased Type I error rates from univariate models. When effect sizes were strongly dependent, error rates were drastically higher than nominal levels regardless of study sample size and number of studies. In contrast, using GLS estimation to account for multiple-endpoint dependency maintained error rates within nominal levels. Conversely, mean I(2) values were not greatly affected by increased amounts of dependency. Last, we point out that the between-outcomes correlation should be estimated as a pooled within-groups correlation rather than using a full-sample estimator that does not consider treatment/control group membership. Copyright © 2014 John Wiley & Sons, Ltd.

  7. The influence of expert opinions on the selection of wastewater treatment alternatives: a group decision-making approach.

    PubMed

    Kalbar, Pradip P; Karmakar, Subhankar; Asolekar, Shyam R

    2013-10-15

    The application of multiple-attribute decision-making (MADM) to real life decision problems suggests that avoiding the loss of information through scenario-based approaches and including expert opinions in the decision-making process are two major challenges that require more research efforts. Recently, a wastewater treatment technology selection effort has been made with a 'scenario-based' method of MADM. This paper focuses on a novel approach to incorporate expert opinions into the scenario-based decision-making process, as expert opinions play a major role in the selection of treatment technologies. The sets of criteria and the indicators that are used consist of both qualitative and quantitative criteria. The group decision-making (GDM) approach that is implemented for aggregating expert opinions is based on an analytical hierarchy process (AHP), which is the most widely used MADM method. The pairwise comparison matrices (PCMs) for qualitative criteria are formed based on expert opinions, whereas, a novel approach is proposed for generating PCMs for quantitative criteria. It has been determined that the experts largely prefer natural treatment systems because they are more sustainable in any scenario. However, PCMs based on expert opinions suggest that advanced technologies such as the sequencing batch reactor (SBR) can also be appropriate for a given decision scenario. The proposed GDM approach is a rationalized process that will be more appropriate in realistic scenarios where multiple stakeholders with local and regional societal priorities are involved in the selection of treatment technology. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. Primary care clinicians' experiences with treatment decision making for older persons with multiple conditions.

    PubMed

    Fried, Terri R; Tinetti, Mary E; Iannone, Lynne

    2011-01-10

    Clinicians are caring for an increasing number of older patients with multiple diseases in the face of uncertainty concerning the benefits and harms associated with guideline-directed interventions. Understanding how primary care clinicians approach treatment decision making for these patients is critical to the design of interventions to improve the decision-making process. Focus groups were conducted with 40 primary care clinicians (physicians, nurse practitioners, and physician assistants) in academic, community, and Veterans Affairs-affiliated primary care practices. Participants were given open-ended questions about their approach to treatment decision making for older persons with multiple medical conditions. Responses were organized into themes using qualitative content analysis. The participants were concerned about their patients' ability to adhere to complex regimens derived from guideline-directed care. There was variability in beliefs regarding, and approaches to balancing, the benefits and harms of guideline-directed care. There was also variability regarding how the participants involved patients in the process of decision making, with clinicians describing conflicts between their own and their patients' goals. The participants listed a number of barriers to making good treatment decisions, including the lack of outcome data, the role of specialists, patient and family expectations, and insufficient time and reimbursement. The experiences of practicing clinicians suggest that they struggle with the uncertainties of applying disease-specific guidelines to their older patients with multiple conditions. To improve decision making, they need more data, alternative guidelines, approaches to reconciling their own and their patients' priorities, the support of their subspecialist colleagues, and an altered reimbursement system.

  9. Randomized controlled pilot study of customized pamphlets to promote physical activity and symptom self-management in women with multiple sclerosis.

    PubMed

    Plow, Matthew; Bethoux, Francois; McDaniel, Corey; McGlynn, Mark; Marcus, Bess

    2014-02-01

    Investigate the feasibility and potential efficacy of a customized print-based intervention to promote physical activity and symptom self-management in women with multiple sclerosis. A randomly allocated two-group repeated measures design, with a delayed-treatment contact group serving as the control. Participants were randomized to receive the intervention immediately (n =14) or receive it at week 12 (n =16). Outcome measures were administered at weeks 1, 12, and 24. Community-based in metropolitan area. Thirty women with multiple sclerosis. Prescribing a home-exercise program and following up with customized pamphlets, which are matched to participants' stage of readiness to change physical activity behavior and physical activity barriers (e.g. encouraging self-management of symptoms). Physical Activity and Disability Survey-revised, Godin Leisure-Time Exercise Questionnaire, SF-12, Symptoms of Multiple Sclerosis Scale, and 6-minute walk test. Intent-to-treat analyses using mixed multivariate analysis of variance (MANOVA) were conducted on (1) physical activity levels and (2) health and function outcomes. The mixed MANOVAs for physical activity levels and health and function outcomes indicated significant improvements in the immediate group compared with the delayed group (i.e. condition by time interaction was significant, Wilks' λ = 0.59, F(2, 27) = 9.31, P = 0.001 and Wilks' λ = 0.70, F(4, 25) = 2.72, P = 0.052, respectively). The intervention had moderate to large effect sizes in improving physical activity levels (d = 0.63 to 0.89), perceptions of physical function (d = 0.63), and 6-minute walk test (d=0.86). This pilot study indicates that a customized print-based intervention shows promise in improving physical activity levels and health and function in women with multiple sclerosis.

  10. Effect of metformin and oral contraceptives on polycystic ovary syndrome and IVF cycles.

    PubMed

    Kalem, M N; Kalem, Z; Gurgan, T

    2017-07-01

    The aim of this study is to investigate the effect of metformin and/or OC added to the treatment of PCOS patients at our clinic on IVF outcome. This study is a retrospective study that assesses the data of PCOS patients who received IVF between 2005 and 2015 at a private IVF center. The study included 496 PCOS cases aged between 24 and 40. Participants diagnosed with PCOS were divided into 4 groups according to the use of metformin and OC prior to the IVF cycle: 11.1% were in the metformin group, 31.3% in the OC group, 14.9% in the Metformin + OC group, and 42.7% in the control group. No difference was found in the total gonadotropin dose and duration of stimulation between the groups. Clinical pregnancy rates and implantation rates were similar in all groups, although the numbers of oocytes, mature oocytes, fertilized oocytes, and transferred embryos were lower in the treatment groups received metformin compared to the OC group and control group. There was no significant difference in the presence of OHSS and the singleton and multiple pregnancies between the four groups. The present study established no positive role of metformin and OC use in increasing the treatment success in IVF/ICSI cycles in PCOS patients. It would be appropriate to limit the use of these agents with special indications such as decreasing insulin resistance or synchronizing follicular cohort.

  11. Influence of laser irradiation on demyelination of nervous fibers

    NASA Astrophysics Data System (ADS)

    Melnik, Nataly O.; Plaksij, Yu. S.; Mamilov, Serge A.

    2000-11-01

    Problem demyelinating diseases from actual in modern of neurology. Main disease of this group - multiple sclerosis, which morphological manifestation is the process demyelineation - disintegration of myelin, which covers axial cylinders of nervous filaments. The outcome of such damage is violation of realization of nervous impulses, dissonance of implement and coordination functions. Most typical the feature of a multiple sclerosis is origin of repeated remissions, which compact with indication remyelination. In development of disease the large role is played by modifications of immunological of a reactivity of an organism. The purpose of the title is development of new methods of treatment of a multiple sclerosis because of lasertherapy. For thsi purpose the influence of a laser exposure on demyelination and remyelination processes will be investigated, is investigated pathological fabrics at microscopic and submicroscopic levels. The study of proceses demyelination and remyelination will be conducted on experimental animals (rats), which are sick experimental allergic encephalomyelitis (EAE), that is the most adequate model of a multiple sclerosis. The patients' EAE animals will be subjected to treatment by a laser exposure. For want of it there will be determinate optimum lengths of waves, dozes and modes of laser radiation.

  12. Intensive social cognitive treatment (can do treatment) with participation of support partners in persons with relapsing remitting multiple sclerosis: observation of improved self-efficacy, quality of life, anxiety and depression 1 year later.

    PubMed

    Jongen, Peter Joseph; Heerings, Marco; Ruimschotel, Rob; Hussaarts, Astrid; Duyverman, Lotte; van der Zande, Anneke; Valkenburg-Vissers, Joyce; van Droffelaar, Maarten; Lemmens, Wim; Donders, Rogier; Visser, Leo H

    2016-07-29

    In persons with multiple sclerosis (MS) self-efficacy positively affects health-related quality of life (HRQoL) and physical activity. In a previous study we observed that 6 months after an intensive 3-day social cognitive treatment (Can Do treatment) with the participation of support partners, self-efficacy and HRQoL had improved in persons with relapsing remitting MS (RRMS). Given the chronic nature of the disease, it is important to know whether these beneficial changes may last. Can Do treatment was given to 60 persons with MS and their support partners. At baseline and 12 months after treatment self-efficacy control, self-efficacy function, physical and mental HRQoL, anxiety, depression and fatigue were assessed via self-report questionnaires. Differences were tested via a paired t test. Of the 57 persons with MS that completed the baseline assessment and the 3-day treatment, 38 filled in the 12th month questionnaires (response rate 66.7 %), 22 with RRMS and 14 with progressive MS. In the RR group self-efficacy control had increased by 20.2 % and physical HRQoL by 15.0 %, and depression and anxiety had decreased by 29.8 and 25.9 %, respectively (all P < 0.05); the changes in mental HRQoL (+17 %) and fatigue (-20 %) failed to be statistically significant (P = 0.087, P = 0.080, respectively). In the progressive group no changes suggestive of improvement were seen. The findings suggest that a 3-day intensive social cognitive treatment (Can Do treatment) with the participation of support partners may have long lasting beneficial effects on the self-efficacy and HRQoL in persons with RRMS; and that improvements in anxiety and depression, not seen in the 6-month study, may yet develop at 12 months.

  13. Cost-effectiveness analysis: controlled-release nifedipine and valsartan combination therapy in patients with essential hypertension: the adalat CR and valsartan cost-effectiveness combination (ADVANCE-Combi) study.

    PubMed

    Saito, Ikuo; Fujikawa, Keita; Saruta, Takao

    2008-07-01

    As recommended by the guidelines such as JSH 2004, combination therapy with multiple agents is now being applied to many patients with hypertension. However, a pharmacoeconomic analysis of each therapy has not been fully undertaken in Japan, despite increasing societal interest. In this study, the cost-effectiveness of two calcium channel blockers, each coadministered with an angiotensin receptor blockade, was compared using data from the ADVANCE-Combi study. The ADVANCE-Combi study was a 16-week double-blind, randomized clinical trial to compare the efficacy and safety of two combination therapies (controlled-release nifedipine [nifedipine CR] plus valsartan vs. amlodipine plus valsartan) on blood pressure (BP) control in patients with moderate to severe essential hypertension. The incremental cost effectiveness of each cohort was compared from the perspective of insurers. The average total cost per patient was Japanese yen (JPY) 31,615 for the nifedipine CR treatment group and JPY 35,399 for the amlodipine treatment group (p < 0.001). The achievement rate of the target BP (SBP/DBP < 130/85 mmHg for patients aged under 60 years; SBP/DBP < 140/90 mmHg for those aged 60 years and over) was significantly higher in the nifedipine CR treatment group (61.2%) than in the amlodipine treatment group (34.6%) (p < 0.001), with no difference in the incidence of drug-related adverse events. Accordingly, the base case economic analysis demonstrated that the nifedipine CR treatment group was dominant (more efficacious and less costly) to the amlodipine treatment group. This result was supported by univariate and probabilistic sensitivity analyses. These results indicate that nifedipine CR-based combination therapy is superior to amlodipine-based combination therapy for the management of essential hypertension in the Japanese population.

  14. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent versus Sequential Intervention

    PubMed Central

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; Schneider, Kristin; Pingitore, Regina; Hedeker, Don

    2014-01-01

    Prospects for changing multiple health behaviors conjointly remain controversial. We compared effects on tobacco abstinence and weight gain of adding diet and exercise concurrently or after smoking treatment. Female regular smokers (n=315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit at week 5, and were followed for 9 months after the quit date. Weight management was added to the first 8 weeks for Early Diet (ED), the final 8 weeks for Late Diet (LD), and omitted for Control. Both Diet groups tended to show greater bio-verified abstinence than Control although differences were nonsignificant. Compared to Control, ED initially suppressed weight gain but lost that effect over time, whereas LD initially lacked but gradually acquired a weight suppression effect that stabilized [p = .004]. Behavioral weight control did not undermine smoking cessation and slowed the rate of weight gain when initiated after the smoking quit date, supporting a sequential approach to multiple behavior change. PMID:15482037

  15. The impact of extended longitudinal observation on the assessment of personality disorders.

    PubMed

    Pedersen, G; Karterud, S; Hummelen, B; Wilberg, T

    2013-11-01

    Multiple sources of information are necessary for a valid assessment of personality disorders (PDs). This study investigates the impact of longitudinal observation. The sample comprised 1217 patients from 15 different treatment units. PDs were assessed at admission to treatment using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) and additional clinical information (best estimate diagnosis). After approximately 18 weeks of treatment, the SCID-II protocols were re-examined at clinical conferences and the diagnostic status reassessed on the basis of longitudinal observations in multiple group situations (longitudinal, expert, all data principle). Using this procedure, 78% of the patients' diagnostic criteria sets were changed, and 32% of patients' diagnostic statuses were changed. Many (32%) patients who were evaluated initially as not having a PD received a PD diagnosis after re-examination. The information provided by customary clinical assessment has important limitations, and longitudinal observation provides additional information that may change the diagnostic status in approximately one-third of PD cases. Copyright © 2013 John Wiley & Sons, Ltd.

  16. Tailor-made rehabilitation approach using multiple types of hybrid assistive limb robots for acute stroke patients: A pilot study.

    PubMed

    Fukuda, Hiroyuki; Morishita, Takashi; Ogata, Toshiyasu; Saita, Kazuya; Hyakutake, Koichi; Watanabe, Junko; Shiota, Etsuji; Inoue, Tooru

    2016-01-01

    This article investigated the feasibility of a tailor-made neurorehabilitation approach using multiple types of hybrid assistive limb (HAL) robots for acute stroke patients. We investigated the clinical outcomes of patients who underwent rehabilitation using the HAL robots. The Brunnstrom stage, Barthel index (BI), and functional independence measure (FIM) were evaluated at baseline and when patients were transferred to a rehabilitation facility. Scores were compared between the multiple-robot rehabilitation and single-robot rehabilitation groups. Nine hemiplegic acute stroke patients (five men and four women; mean age 59.4 ± 12.5 years; four hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using multiple types of HAL robots for 19.4 ± 12.5 days, and 14 patients (six men and eight women; mean age 63.2 ± 13.9 years; nine hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using a single type of HAL robot for 14.9 ± 8.9 days. The multiple-robot rehabilitation group showed significantly better outcomes in the Brunnstrom stage of the upper extremity, BI, and FIM scores. To the best of the authors' knowledge, this is the first pilot study demonstrating the feasibility of rehabilitation using multiple exoskeleton robots. The tailor-made rehabilitation approach may be useful for the treatment of acute stroke.

  17. Group Training in Interpersonal Problem-Solving Skills for Workplace Adaptation of Adolescents and Adults with Asperger Syndrome: A Preliminary Study

    ERIC Educational Resources Information Center

    Bonete, Saray; Calero, María Dolores; Fernández-Parra, Antonio

    2015-01-01

    Adults with Asperger syndrome show persistent difficulties in social situations which psychosocial treatments may address. Despite the multiple studies focusing on social skills interventions, only some have focused specifically on problem-solving skills and have not targeted workplace adaptation training in the adult population. This study…

  18. Incidence of post-operative pain after single visit and multiple visit root canal treatment: A randomized controlled trial

    PubMed Central

    Singh, Smita; Garg, Aniket

    2012-01-01

    Aim: To compare the incidence and intensity of post-obturation pain after single or multi visit root canal treatment on single rooted teeth in a randomized controlled trial. Materials and Methods: Two hundred patients requiring root canal treatment on permanent single rooted teeth (both vital and non vital) were included. The patients were assigned randomly into two groups of 100 patients each. The teeth in Group1 (n = 100) were obturated at the first visit, whilst those in Group 2 (n = 100) were obturated in a second visit 7 days later. A modified Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 6, 12, 24 and 48 hours after obturation. Independent-sample T-tests was used for statistical analysis. Results: Twelve patients were excluded from the study as they failed to follow the scheduled revisit. Data were obtained from the remaining 188 patients. There was no statistically significant difference in the incidence and intensity of post-obturation pain experienced by two groups. Conclusions: The incidence and intensity of post-obturation pain experience following one- or two-visit root canal treatment on teeth with a single canal were not significantly different. PMID:23112477

  19. Is endotracheal intubation a non-beneficial treatment in patients with respiratory failure due to paraquat poisoning?

    PubMed Central

    Wu, Meng-Ruey; Hsiao, Chia-Ying; Cheng, Chun-Han; Liao, Feng-Ching; Chao, Chuan-Lei; Chen, Chun-Yen; Yeh, Hung-I

    2018-01-01

    Introduction Paraquat poisoning can result in dysfunction of multiple organs, and pulmonary fibrosis with respiratory failure is the major cause of mortality. For terminally ill patients, some life-prolonging treatments can be non-beneficial treatments (NBT). The objective of this study was to determine if intubation is a NBT for patients with respiratory failure due to paraquat poisoning. Methods The study included 68 patients with respiratory failure due to paraquat poisoning. Patients were hospitalized at MacKay Memorial Hospital, Taitung Branch, Taiwan, between 2005 to April 2016. Composite outcomes of intra-hospital mortality, the rate of do-not-resuscitate (DNR) orders, prescribed medications, length of stay, and medical costs were recorded and compared between the do-not-intubate (DNI) group and endotracheal intubation (EI) group. Results Intra-hospital mortality rate for the entire population was 100%. There were significantly more patients with DNR orders in the DNI group (P = 0.007). There were no differences in the length of hospital stay. However, patients in DNI group had significantly less vasopressor use and more morphine use, shorter time in the intensive care unit, and fewer medical costs. Conclusion The procedure of intubation in patients with respiratory failure due to paraquat poisoning can be considered inappropriate life-prolonging treatment. PMID:29590187

  20. Prediction of Therapeutic Effect of Chemotherapy for NSCLC Using Dual-Input Perfusion CT Analysis: Comparison among Bevacizumab Treatment, Two-Agent Platinum-based Therapy without Bevacizumab, and Other Non-Bevacizumab Treatment Groups.

    PubMed

    Yabuuchi, Hidetake; Kawanami, Satoshi; Iwama, Eiji; Okamoto, Isamu; Kamitani, Takeshi; Sagiyama, Koji; Yamasaki, Yuzo; Honda, Hiroshi

    2018-02-01

    Purpose To determine whether dual-input perfusion computed tomography (CT) can predict therapeutic response and prognosis in patients who underwent chemotherapy for non-small cell lung cancer (NSCLC). Materials and Methods The institutional review board approved this study and informed consent was obtained. Sixty-six patients with stage III or IV NSCLC (42 men, 24 women; mean age, 63.4 years) who underwent chemotherapy were enrolled. Patients were separated into three groups: those who received chemotherapy with bevacizumab (BV) (n = 20), those who received two-agent platinum-based therapy without BV (n = 25), and those who received other non-BV treatment (n = 21). Before treatment, pulmonary artery perfusion (PAP) and bronchial artery perfusion (BAP) of the tumors were calculated. Predictors of tumor reduction after two courses of chemotherapy and prognosis were identified by using univariate and multivariate analyses. Covariates included were age, sex, patient's performance status, baseline maximum diameter of the tumor, clinical stage, pretreatment PAP, and pretreatment BAP. For multivariate analyses, multiple linear regression analysis for tumor reduction rate and Cox proportional hazards model for prognosis were performed, respectively. Results Pretreatment BAP was independently correlated with tumor reduction rate after two courses of chemotherapy in the BV treatment group (P = .006). Pretreatment BAP was significantly associated with a highly cumulative risk of death (P = .006) and disease progression after chemotherapy (P = .015) in the BV treatment group. Pretreatment PAP and clinical parameters were not significant predictors of therapeutic effect or prognosis in three treatment groups. Conclusion Pretreatment BAP derived from dual-input perfusion CT seems to be a promising tool to help predict responses to chemotherapy with BV in patients with NSCLC. © RSNA, 2017.

  1. Traditional chinese medicine Xuebijing treatment is associated with decreased mortality risk of patients with moderate paraquat poisoning.

    PubMed

    Gong, Ping; Lu, Zhidan; Xing, Jing; Wang, Na; Zhang, Yu

    2015-01-01

    Paraquat poisoning causes multiple organ injury and high mortality due to severe toxicity and lack of effective treatment. Xuebijing (XBJ) injection, a traditional Chinese medicine preparation of five Chinese herbs (Radix Salviae Miltiorrhiae, Rhizoma Chuanxiong, Flos Carthami, Angelica Sinensis and Radix Paeoniae Rubra), has an anti-inflammatory effect and is widely used in the treatment of sepsis. This retrospective study was designed to evaluate the effects of XBJ combined with conventional therapy on mortality risk of patients with acute paraquat poisoning. Out of 68 patients, 27 were treated with conventional therapy (control group) and 41 were treated with intravenous administration of XBJ (100 ml, twice a day, up to 7 days) plus conventional therapy (XBJ group). Vital organ function, survival time within 28 days and adverse events during the treatment were reviewed. Results indicated that XBJ treatment significantly increased median survival time among patients ingesting 10-30 ml of paraquat (P=0.02) compared with the control group. After adjustment for covariates, XBJ treatment was associated significantly with a lower mortality risk (adjusted HR 0.242, 95% CI 0.113 to 0.516, P=0.001) compared with the control group. Additionally, compared with Day 1, on Day 3 the value of PaO2/FiO2 was significantly decreased, and the values of serum alanine aminotransferase, creatinine and troponin T were significantly increased in the control group (all P<0.05), but these values were significant improved in the XBJ group (all P<0.05). Only one patient had skin rash with itch within 30 minutes after injection and no severe adverse events were found in the XBJ group. In conclusion, XBJ treatment is associated with decreased mortality risk of patients with moderate paraquat poisoning, which may be attributed to improved function of vital organs with no severe adverse events.

  2. Traditional Chinese Medicine Xuebijing Treatment Is Associated with Decreased Mortality Risk of Patients with Moderate Paraquat Poisoning

    PubMed Central

    Gong, Ping; Xing, Jing; Wang, Na

    2015-01-01

    Paraquat poisoning causes multiple organ injury and high mortality due to severe toxicity and lack of effective treatment. Xuebijing (XBJ) injection, a traditional Chinese medicine preparation of five Chinese herbs (Radix Salviae Miltiorrhiae, Rhizoma Chuanxiong, Flos Carthami, Angelica Sinensis and Radix Paeoniae Rubra), has an anti-inflammatory effect and is widely used in the treatment of sepsis. This retrospective study was designed to evaluate the effects of XBJ combined with conventional therapy on mortality risk of patients with acute paraquat poisoning. Out of 68 patients, 27 were treated with conventional therapy (control group) and 41 were treated with intravenous administration of XBJ (100 ml, twice a day, up to 7 days) plus conventional therapy (XBJ group). Vital organ function, survival time within 28 days and adverse events during the treatment were reviewed. Results indicated that XBJ treatment significantly increased median survival time among patients ingesting 10-30 ml of paraquat (P=0.02) compared with the control group. After adjustment for covariates, XBJ treatment was associated significantly with a lower mortality risk (adjusted HR 0.242, 95% CI 0.113 to 0.516, P=0.001) compared with the control group. Additionally, compared with Day 1, on Day 3 the value of PaO2/FiO2 was significantly decreased, and the values of serum alanine aminotransferase, creatinine and troponin T were significantly increased in the control group (all P<0.05), but these values were significant improved in the XBJ group (all P<0.05). Only one patient had skin rash with itch within 30 minutes after injection and no severe adverse events were found in the XBJ group. In conclusion, XBJ treatment is associated with decreased mortality risk of patients with moderate paraquat poisoning, which may be attributed to improved function of vital organs with no severe adverse events. PMID:25923333

  3. Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

    PubMed Central

    Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

    2016-01-01

    Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

  4. Multiplicative surrogate standard deviation: a group metric for the glycemic variability of individual hospitalized patients.

    PubMed

    Braithwaite, Susan S; Umpierrez, Guillermo E; Chase, J Geoffrey

    2013-09-01

    Group metrics are described to quantify blood glucose (BG) variability of hospitalized patients. The "multiplicative surrogate standard deviation" (MSSD) is the reverse-transformed group mean of the standard deviations (SDs) of the logarithmically transformed BG data set of each patient. The "geometric group mean" (GGM) is the reverse-transformed group mean of the means of the logarithmically transformed BG data set of each patient. Before reverse transformation is performed, the mean of means and mean of SDs each has its own SD, which becomes a multiplicative standard deviation (MSD) after reverse transformation. Statistical predictions and comparisons of parametric or nonparametric tests remain valid after reverse transformation. A subset of a previously published BG data set of 20 critically ill patients from the first 72 h of treatment under the SPRINT protocol was transformed logarithmically. After rank ordering according to the SD of the logarithmically transformed BG data of each patient, the cohort was divided into two equal groups, those having lower or higher variability. For the entire cohort, the GGM was 106 (÷/× 1.07) mg/dl, and MSSD was 1.24 (÷/× 1.07). For the subgroups having lower and higher variability, respectively, the GGM did not differ, 104 (÷/× 1.07) versus 109 (÷/× 1.07) mg/dl, but the MSSD differed, 1.17 (÷/× 1.03) versus 1.31 (÷/× 1.05), p = .00004. By using the MSSD with its MSD, groups can be characterized and compared according to glycemic variability of individual patient members. © 2013 Diabetes Technology Society.

  5. Effect of topical chamomile on immunohistochemical levels of IL-1β and TNF-α in 5-fluorouracil-induced oral mucositis in hamsters.

    PubMed

    Curra, Marina; Martins, Marco Antonio T; Lauxen, Isabel S; Pellicioli, Ana Carolina A; Sant'Ana Filho, Manoel; Pavesi, Vanessa Christina S; Carrard, Vinicius C; Martins, Manoela D

    2013-02-01

    The aim of the present study was to evaluate the effect of topical chamomile and corticosteroid treatment on the profile of tissue cytokines (IL-1β and TNF-α) in 5-fluorouracil-induced oral mucositis in hamsters. Thirty-six hamsters were randomly separated into three groups (12 animals each): Group I--without treatment (control); Group II-treatment with chamomile (Ad-Muc(®)); and Group III--treatment with corticosteroid (betamethasone elixir- Celestone(®)). The animals received an intraperitoneal injection of 5--fluorouracil on Days 0 and 2. On Days 3 and 4, the buccal mucosa was scratched and therapy was initiated on Day 5. Three animals from each group were killed on Days 0, 5, 10, and 14 and the buccal mucosa was removed. The streptavidin-biotin complex method was used to delineate the in situ distribution, localization, and semiquantitative analysis of IL-1β and TNF-α. Data from the semiquantitative analysis of immunohistochemical staining were comparatively analyzed using the Kruskal-Wallis test, followed by Dunn's multiple comparisons test. The distribution and localization of IL-1β and TNF-α immunolabeling were similar. These proteins exhibited a diffuse pattern distributed throughout the connective tissue. The epithelium and adipose tissue were negative for both proteins. The semiquantitative analysis revealed that immunolabeling of IL-1β and TNF-α increased in all groups with the development of mucositis. On Day 10 (period of peak mucositis), the group treated with chamomile had lower scores for both pro-inflammatory cytokines. Treatment with topical chamomile reduced the tissue levels of IL-1β and TNF-α, thereby demonstrating anti-inflammatory action in oral mucositis in hamsters.

  6. Assertive outreach in Slovenia; identification of target group and goals of treatment in a new program.

    PubMed

    Furlan, Mirjana

    2009-09-01

    A team from the Rehabilitation unit of Ljubljana psychiatric clinic attended a course on community care in London in October and November 2005. Because we decided that the methods presented to us could be of great use in Slovenia where the Health system is lacking such services we decided to implement them after our return. Immediately after we returned we started to carry out our plan. We designated our target group which were patients who poorly participated in treatment or had multiple and severe difficulties functioning and retaining their progress after discharge. Our goals were to improve patient participation in treatment before and after discharge, less and shorter hospitalizations and better integration of patients into society. Initial results are very positive, which leaves me much hope for further implementation of assertive outreach and community care in Slovenia.

  7. Cannabis Abstinence During Treatment and One-Year Follow-Up: Relationship to Neural Activity in Men

    PubMed Central

    Kober, Hedy; DeVito, Elise E; DeLeone, Cameron M; Carroll, Kathleen M; Potenza, Marc N

    2014-01-01

    Cannabis is among the most frequently abused substances in the United States. Cognitive control is a contributory factor in the maintenance of substance-use disorders and may relate to treatment response. Therefore, we assessed whether cognitive-control-related neural activity before treatment differs between treatment-seeking cannabis-dependent and healthy individuals and relates to cannabis-abstinence measures during treatment and 1-year follow-up. Cannabis-dependent males (N=20) completed a functional magnetic resonance imaging (fMRI) cognitive-control (Stroop) task before a 12-week randomized controlled trial of cognitive–behavioral therapy and/or contingency management. A healthy-comparison group (N=20) also completed the fMRI task. Cannabis use was assessed by urine toxicology and self-report during treatment, and by self-report across a 1-year follow-up period (N=18). The cannabis-dependent group displayed diminished Stroop-related neural activity relative to the healthy-comparison group in multiple regions, including those strongly implicated in cognitive-control and addiction-related processes (eg, dorsolateral prefrontal cortex and ventral striatum). The groups did not differ significantly in response times (cannabis-dependent, N=12; healthy-comparison, N=14). Within the cannabis-dependent group, greater Stroop-related activity in regions including the dorsal anterior cingulate cortex was associated with less cannabis use during treatment. Greater activity in regions including the ventral striatum was associated with less cannabis use during 1-year posttreatment follow-up. These data suggest that lower cognitive-control-related neural activity in classic ‘control' regions (eg, dorsolateral prefrontal cortex and dorsal anterior cingulate) and classic ‘salience/reward/learning' regions (eg, ventral striatum) differentiates cannabis-dependent individuals from healthy individuals and relates to less abstinence within-treatment and during long-term follow-up. Clinically, results suggest that treatment development efforts that focus on enhancing cognitive control in addition to abstinence may improve treatment outcomes in cannabis dependence. PMID:24705568

  8. Cannabis abstinence during treatment and one-year follow-up: relationship to neural activity in men.

    PubMed

    Kober, Hedy; DeVito, Elise E; DeLeone, Cameron M; Carroll, Kathleen M; Potenza, Marc N

    2014-09-01

    Cannabis is among the most frequently abused substances in the United States. Cognitive control is a contributory factor in the maintenance of substance-use disorders and may relate to treatment response. Therefore, we assessed whether cognitive-control-related neural activity before treatment differs between treatment-seeking cannabis-dependent and healthy individuals and relates to cannabis-abstinence measures during treatment and 1-year follow-up. Cannabis-dependent males (N=20) completed a functional magnetic resonance imaging (fMRI) cognitive-control (Stroop) task before a 12-week randomized controlled trial of cognitive-behavioral therapy and/or contingency management. A healthy-comparison group (N=20) also completed the fMRI task. Cannabis use was assessed by urine toxicology and self-report during treatment, and by self-report across a 1-year follow-up period (N=18). The cannabis-dependent group displayed diminished Stroop-related neural activity relative to the healthy-comparison group in multiple regions, including those strongly implicated in cognitive-control and addiction-related processes (eg, dorsolateral prefrontal cortex and ventral striatum). The groups did not differ significantly in response times (cannabis-dependent, N=12; healthy-comparison, N=14). Within the cannabis-dependent group, greater Stroop-related activity in regions including the dorsal anterior cingulate cortex was associated with less cannabis use during treatment. Greater activity in regions including the ventral striatum was associated with less cannabis use during 1-year posttreatment follow-up. These data suggest that lower cognitive-control-related neural activity in classic 'control' regions (eg, dorsolateral prefrontal cortex and dorsal anterior cingulate) and classic 'salience/reward/learning' regions (eg, ventral striatum) differentiates cannabis-dependent individuals from healthy individuals and relates to less abstinence within-treatment and during long-term follow-up. Clinically, results suggest that treatment development efforts that focus on enhancing cognitive control in addition to abstinence may improve treatment outcomes in cannabis dependence.

  9. Three-dimensional multiple object tracking in the pediatric population: the NeuroTracker and its promising role in the management of mild traumatic brain injury.

    PubMed

    Corbin-Berrigan, Laurie-Ann; Kowalski, Kristina; Faubert, Jocelyn; Christie, Brian; Gagnon, Isabelle

    2018-05-02

    As mild traumatic brain injury (mTBI) affects hundreds of thousands of children and their families each year, investigation of potential mTBI assessments and treatments is an important research target. Three-dimensional multiple object tracking (3D-MOT), where an individual must allocate attention to moving objects within 3D space, is one potentially promising assessment and treatment tool. To date, no research has looked at 3D-MOT in a pediatric mTBI population. Thus, the aim of this study was to examine 3D-MOT learning in children and youth with and without mTBI. Thirty-four participants (mean age=14.69±2.46 years), with and without mTBI, underwent six visits of 3D-MOT. A two-way repeated-measures analysis of variance (ANOVA) showed a significant time effect, a nonsignificant group effect, and a nonsignificant group-by-time interaction on absolute speed thresholds. In contrast, significant group and time effects and a significant group-by-time interaction on normalized speed thresholds were found. Individuals with mTBI showed smaller training gains at visit 2 than healthy controls, but the groups did not differ on the remaining visits. Although youth can significantly improve their 3D-MOT performance following mTBI, similar to noninjured individuals, they show slower speed of processing in the first few training sessions. This preliminary work suggests that using a 3D-MOT paradigm to train visual perception after mTBI may be beneficial for both stimulating recovery and informing return to activity decisions.

  10. Stem cell implantation for osteonecrosis of the femoral head.

    PubMed

    Lim, Young Wook; Kim, Yong Sik; Lee, Jong Wook; Kwon, Soon Yong

    2013-11-15

    What is the most effective treatment for the early stages of osteonecrosis of the femoral head? We assessed multiple drilling and stem cell implantation to treat the early stages of osteonecrosis of the femoral head. We report the clinical and radiological results of stem cell implantation and core decompression. In total, 128 patients (190 hips) who had undergone surgery were divided into two groups based on which treatment they had received: (1) multiple drilling and stem cell implantation or (2) core decompression, curettage and a bone graft. The clinical and radiographic results of the two groups were compared. At 5-year follow-up, in the stem cell implantation group, 64.3% (27/42) of the patients with Stage IIa disease, 56.7% (21/37) of the patients with Stage IIb disease and 42.9% (21/49) of the patients with Stage III disease had undergone no additional surgery. In the conventional core decompression group, 64.3% (9/14) of the patients with Stage IIa disease, 55.6% (5/9) of the patients with Stage IIb disease and 37.5% (3/8) of the patients with Stage III disease had undergone no additional surgery. Success rates were higher in patients with Ficat Stage I or II lesions than in those with Stage III lesions. There were no statistically significant differences between the groups in terms of success rate or in the clinical and radiographic results of the two methods. Essentially the same results were found with stem cell implantation as with the conventional method of core decompression.

  11. Treatment of periodontitis in smokers with multiple sessions of antimicrobial photodynamic therapy or systemic antibiotics: A randomized clinical trial.

    PubMed

    Theodoro, Letícia Helena; Assem, Naida Zanini; Longo, Mariéllen; Alves, Márcio Luiz Ferro; Duque, Cristiane; Stipp, Rafael Nobrega; Vizoto, Natália Leal; Garcia, Valdir Gouveia

    2018-06-01

    The aim of this study was to evaluate the effects of non-surgical periodontal therapies on smokers with chronic periodontitis, involving multiple adjunctive applications of antimicrobial photodynamic therapy (aPDT), and systemic metronidazole (MTZ) with amoxicillin (AMX). All participants were treated with scaling and root planing (SRP). Seventeen patients received 400 mg of MTZ and 500 mg of AMX three times per day for 7 days (MTZ + AMX). Additionally, 17 patients received a placebo, and 17 patients were treated with three applications of aPDT (immediately, 48 h and 96 h after SRP). Clinical and microbiological examinations were performed at baseline and at 90 and 180 days post-therapy. Subgingival samples were analyzed using real-time polymerase chain reaction. After 180 days, the patients in groups MTZ + AMX and aPDT had significantly lower mean probing depths, more clinical attachment level gains and less bleeding on probing. At 180 days, in the moderate pocket there was a reduction in the levels of Porphyromonas gingivalis and Prevotella nigrescens in the MTZ + AMX group, while group aPDT showed a reduction in Prevotella nigrescens. Furthermore, at 180 days, in the deep pocket a reduction in Porphyromonas gingivalis, Prevotella intermedia and Prevotella nigrescens was observed in group MTZ + AMX, as well as a reduction in the levels of Prevotella intermedia and Prevotella nigrescens in group aPDT. In smokers with periodontitis, the MTZ + AMX and aPDT treatments significantly improved the effects of SRP. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. Dynamics of HPV viral loads reflect the treatment effect of photodynamic therapy in genital warts.

    PubMed

    Hu, Zhili; Liu, Lishi; Zhang, Wenjing; Liu, Hui; Li, Junpeng; Jiang, Lifen; Zeng, Kang

    2018-03-01

    Photodynamic therapy (PDT) has demonstrated good clinical cure rates and low recurrence rates in the treatment of genital warts. Human papillomavirus (HPV) genotypes and viral load assays can reflect the status of persistent or latent infection and serve as a predictor of infection clearance. Specimens from 41 patients with HPV infection were obtained, and the HPV genotypes and viral load were analyzed using real-time polymerase chain reaction (PCR) assays. Traditional treatment, such as radiofrequency, microwave, or surgical therapy, was used to remove the visible lesions, and then PDT treatment was performed every week. HPV DNA testing was performed at every patient visit and the frequency of PDT treatment was determined by changes in HPV viral loads. HPV viral loads decreased significantly after PDT treatment. There were significant differences in HPV viral loads between pretherapy and three or six rounds of PDT treatment. Significant differences were also observed between single and multiple type HPV infection after six rounds of PDT treatment. Patients with single type HPV infection had significantly higher rates of negative HPV DNA test results, as compared with patients with multiple infections after six rounds of PDT treatment; however, there was no difference in recurrence rates between the two groups. Dynamic monitoring of HPV genotypes and viral loads can be used to guide PDT treatment and indicate PDT treatment efficacy in eliminating HPV. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Affective mediators of a physical activity intervention for depression in multiple sclerosis.

    PubMed

    Kratz, Anna L; Ehde, Dawn M; Bombardier, Charles H

    2014-02-01

    Previous analyses showed that a telephone-based intervention to increase physical activity in individuals with multiple sclerosis (MS) and depression resulted in significantly improved depressive symptoms compared to a wait-list control group. The aim of this study was to test positive affect and negative affect as mediators of the effect of the physical activity counseling on depressive symptoms. Ninety-two adults with MS, who met diagnostic criteria for either major depression or dysthymia and who reported low levels of physical activity, were randomized 1:1 to a 12-week telephone-based motivational interviewing (MI) intervention to improve physical activity (n = 44) or to a 12-week wait-list control group (n = 48). Self-reported positive and negative affect, physical activity, and depressive symptoms were gathered at baseline and postintervention. Path-analysis was used to test whether positive affect and negative affect mediated the positive effects of the intervention on depressive symptoms. Both positive and negative affect were significant mediators of the effects of the intervention on depressive symptoms; however, only positive affect mediated the association between changes in physical activity and improved depressive symptoms. Findings support physical activity and positive affect as key mediators of the MI treatment effect on improved mood. Decreases in negative affect were also evident in the treatment group, but were not related to improved physical activity. Findings may suggest the use of exercise-based interventions in conjunction with treatments that specifically target negative affective mechanisms for depression. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  14. Acarbose treatment affects the serum levels of inflammatory cytokines and the gut content of bifidobacteria in Chinese patients with type 2 diabetes mellitus.

    PubMed

    Su, Benli; Liu, Haixia; Li, Jing; Sunli, Yongjuan; Liu, Ben; Liu, Dandan; Zhang, Ping; Meng, Xiuxiang

    2015-09-01

    The effects of acarbose add-on therapy on gut microbiota and inflammatory cytokines were investigated in Chinese patients with type 2 diabetes mellitus (DM). Ninety-five DM patients were randomly allocated to two groups: 59 to Group A who received antidiabetic treatment that included acarbose 150 mg/day, and 36 to Group B who received similar treatment to Group A but without acarbose. Forty-five healthy volunteers were selected as a control group. Serum concentrations of inflammatory cytokines were determined by ELISA, and the contents of 16S rDNA of gut bacteria were determined by real-time quantitative polymerase chain reaction. General linear analysis for repeated measurements was used to analyze trend differences between the two diabetic groups. After 4 weeks of antidiabetic treatment, the gut contents of Bifidobacterium longum and Enterococcus faecalis were significantly increased in both diabetes groups. The increase of Bifidobacterium longum (P = 0.004) and the decrease of lipopolysaccharides (LPS) (P < 0.001) and prothrombin activator inhibitor-1 (P = 0.003) were more significant in Group A. Decreases of monocyte chemoattractant protein-1 and LPS were more significant in patients whose HbA1c decrease was ≥1%, but there were no significant differences in the changes of other cytokines and gut bacteria between patients with HbA1c <7% and ≥7%. Pearson correlation analysis showed that changes of Enterococcus faecalis were negatively correlated with LPS, while multiple linear regression analysis showed a positive correlation of Bifidobacterium longum with acarbose treatment and the high-density lipoprotein cholesterol concentration. Acarbose treatment can increase the content of gut Bifidobacterium longum in type 2 diabetes mellitus patients and decrease some inflammatory cytokines independently of its antihyperglycemic effects. © 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  15. Nitric Oxide Decreases Acute Kidney Injury and Stage 3 Chronic Kidney Disease after Cardiac Surgery.

    PubMed

    Lei, Chong; Berra, Lorenzo; Rezoagli, Emanuele; Yu, Binglan; Dong, Hailong; Yu, Shiqiang; Hou, Lihong; Chen, Min; Chen, Wensheng; Wang, Hongbing; Zheng, Qijun; Shen, Jie; Jin, Zhenxiao; Chen, Tao; Zhao, Rong; Christie, Emily; Sabbisetti, Venkata S; Nordio, Francesco; Bonventre, Joseph V; Xiong, Lize; Zapol, Warren M

    2018-06-22

    No medical intervention has been identified that decreases acute kidney injury and improves renal outcome at 1-year after cardiac surgery. To determine whether administration of nitric oxide reduces the incidence of post-operative acute kidney injury and improves long-term kidney outcomes after multiple cardiac valve replacement requiring prolonged cardiopulmonary bypass. 244 Patients undergoing elective, multiple valve replacement surgery mostly due to rheumatic fever were randomized to receive either nitric oxide (treatment) or nitrogen (control). Nitric oxide and nitrogen were administered via the gas exchanger during cardiopulmonary bypass and by inhalation for 24h post-operatively. Primary outcome: Oxidation of ferrous plasma oxyhemoglobin to ferric methemoglobin was associated to a reduced post-operative acute kidney injury from 64% (control group) to 50% (nitric oxide) (RR, 95% CI; 0.78, 0.62-0.97;P=0.014). At 90-days, transition to stage 3 chronic kidney disease was reduced from 33% in the controls to 21% in the treatment group (RR, 95%CI; 0.64, 0.41 - 0.99;P=0.024); and at 1-year, from 31% to 18% (RR, 95% CI; 0.59, 0.36 - 0.96;P=0.017). Nitric oxide treatment reduced the overall major adverse kidney events at 30-days (RR, 95% CI; 0.40, 0.18 - 0.92;P=0.016, 90-days (RR, 95% CI; 0.40, 0.17 - 0.92;P=0.015 and 1-year (RR, 95% CI; 0.47, 0.20-1.10;P=0.041). In patients undergoing multiple valve replacement and prolonged cardiopulmonary bypass, administration of nitric oxide decreased the incidence of acute kidney injury, transition to stage 3 chronic kidney disease and major adverse kidney events at 30-days, 90-days, and 1-year. Clinical trial registered with ClinicalTrials.gov (NCT01802619).

  16. Eating oysters without risk of vibriosis: application of a bacteriophage against Vibrio parahaemolyticus in oysters.

    PubMed

    Jun, Jin Woo; Kim, Hyoun Joong; Yun, Sae Kil; Chai, Ji Young; Park, Se Chang

    2014-10-01

    Vibrio parahaemolyticus is a major cause of foodborne illness and related with the consumption of raw contaminated seafood, especially oysters. To evaluate the effectiveness of various applications of a bacteriophage (phage), pVp-1, against a multiple-antibiotic-resistant V. parahaemolyticus pandemic strain (CRS 09-17), we designed artificial contamination models that are most likely to be encountered during oyster processing. When live oysters were treated with bath immersion with pVp-1 after CRS 09-17 challenge, the growth of bacterial strain was significantly reduced. After 72h of phage application with bath immersion, bacterial growth reduction was observed to be 8.9×10(6)CFU/ml (control group) to 1.4×10CFU/ml (treatment group). When pVp-1 was surface-applied on the flesh of oysters after CRS 09-17 inoculation, bacterial growth was properly inhibited. After 12h of phage application on the surface of oysters, bacterial growth inhibition was revealed to be 1.44×10(6)CFU/ml (control group) to 1.94CFU/ml (treatment group). This is the first report, to the best of our knowledge, of oyster surface-application of a phage against a multiple-antibiotic-resistant V. parahaemolyticus pandemic strain, and our successful phage application to various situations emphasizes the potential use of the phage to avoid V. parahaemolyticus infection from aquaculture to consumption. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. How Can eHealth Technology Address Challenges Related to Multimorbidity? Perspectives from Patients with Multiple Chronic Conditions.

    PubMed

    Zulman, Donna M; Jenchura, Emily C; Cohen, Danielle M; Lewis, Eleanor T; Houston, Thomas K; Asch, Steven M

    2015-08-01

    Patient eHealth technology offers potential support for disease self-management, but the value of existing applications for patients with multiple chronic conditions (MCCs) is unclear. To understand self-management and health care navigation challenges that patients face due to MCCs and to identify opportunities to support these patients through new and enhanced eHealth technology. After administering a screening survey, we conducted 10 focus groups of 3-8 patients grouped by age, sex, and common chronic conditions. Patients discussed challenges associated with having MCCs and their use of (and desires from) technology to support self-management. Three investigators used standard content analysis methods to code the focus group transcripts. Emergent themes were reviewed with all collaborators, and final themes and representative quotes were validated with a sample of participants. Fifty-three individuals with ≥3 chronic conditions and experience using technology for health-related purposes. Focus group participants had an average of five chronic conditions. Participants reported using technology most frequently to search for health information (96%), communicate with health care providers (92%), track medical information (83%), track medications (77%), and support decision-making about treatment (55%). Three themes emerged to guide eHealth technology development: (1) Patients with MCCs manage a high volume of information, visits, and self-care tasks; (2) they need to coordinate, synthesize, and reconcile health information from multiple providers and about different conditions; (3) their unique position at the hub of multiple health issues requires self-advocacy and expertise. Focus groups identified desirable eHealth resources and tools that reflect these themes. Although patients with multiple health issues use eHealth technology to support self-care for specific conditions, they also desire tools that transcend disease boundaries. By addressing the holistic needs of patients with MCCs, eHealth technology can advance health care from a disease-centered to a patient-centered model.

  18. Relational Psychotherapy Mothers’ Group: A developmentally informed intervention for at-risk mothers

    PubMed Central

    Luthar, Suniya S.; Suchman, Nancy E.

    2012-01-01

    The Relational Psychotherapy Mothers’ Group (RPMG), a developmentally informed, supportive psychotherapy designed to serve heroin-addicted mothers with children up to 16 years of age, aims at addressing psychosocial vulnerabilities, and facilitating optimal parenting, among at-risk mothers. We present preliminary evidence on the efficacy of RPMG as an “add on” treatment in comparison with standard methadone counseling alone. At the end of the 24-week treatment period, mothers receiving RPMG plus standard methadone counseling demonstrated lower levels of risk for child maltreatment, greater involvement with their children, and more positive psychosocial adjustment than women who received methadone counseling alone. Children of RPMG participants also reflected fewer problems in multiple areas. At 6 months posttreatment, RPMG recipients continued to be at a relative advantage, although the magnitude of group differences was often attenuated. Notably, urinalyses indicated that RPMG mothers showed greater improvements in levels of opioid use over time than comparison mothers. PMID:10847626

  19. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial.

    PubMed

    Braendvik, Siri Merete; Koret, Teija; Helbostad, Jorunn L; Lorås, Håvard; Bråthen, Geir; Hovdal, Harald Olav; Aamot, Inger Lise

    2016-12-01

    The most effective treatment approach to improve walking in people with multiple sclerosis (MS) is not known. The aim of this trial was to assess the efficacy of treadmill training and progressive strength training on walking in people with MS. A single blinded randomized parallel group trial was carried out. Eligible participants were adults with MS with Expanded Disability Status Scale score ≤6. A total of 29 participants were randomized and 28 received the allocated exercise intervention, treadmill (n = 13) or strength training (n = 15). Both groups exercised 30 minutes, three times a week for 8 weeks. Primary outcome was The Functional Ambulation Profile evaluated by the GAITRite walkway. Secondary outcomes were walking work economy and balance control during walking, measured by a small lightweight accelerometer connected to the lower back. Testing was performed at baseline and the subsequent week after completion of training. Two participants were lost to follow-up, and 11 (treadmill) and 15 (strength training) were left for analysis. The treadmill group increased their Functional Ambulation Profile score significantly compared with the strength training group (p = .037). A significant improvement in walking work economy (p = .024) and a reduction of root mean square of vertical acceleration (p = .047) also favoured the treadmill group. The results indicate that task-specific training by treadmill walking is a favourable approach compared with strength training to improve walking in persons with mild and moderate MS. Implications for Physiotherapy practice, this study adds knowledge for the decision of optimal treatment approaches in people with MS. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  20. In vitro evaluation of mitochondrial dysfunction and treatment with adeno-associated virus vector in fibroblasts from Doberman Pinschers with dilated cardiomyopathy and a pyruvate dehydrogenase kinase 4 mutation.

    PubMed

    Sosa, Ivan; Estrada, Amara H; Winter, Brandy D; Erger, Kirsten E; Conlon, Thomas J

    2016-02-01

    To compare mitochondrial oxygen consumption rate (OCR) of fibroblasts from Doberman Pinschers with and without dilated cardiomyopathy (DCM) and mutation of the gene for pyruvate dehydrogenase kinase isozyme 4 (PDK4) and to evaluate in vitro whether treatment with adeno-associated virus (AAV) vector (i.e., gene therapy) would alter metabolic efficiency. 10 Doberman Pinschers screened for DCM and PDK4 mutation. PROCEDURES Fibroblasts were harvested from skin biopsy specimens obtained from Doberman Pinschers, and dogs were classified as without DCM or PDK4 mutation (n = 3) or with occult DCM and heterozygous (4) or homozygous (3) for PDK4 mutation. Fibroblasts were or were not treated with tyrosine mutant AAV type 2 vector containing PDK4 at multiplicities of infection of 1,000. Mitochondrial OCR was measured to evaluate mitochondrial metabolism. The OCR was compared among dog groups and between untreated and treated fibroblasts within groups. Mean ± SD basal OCR of fibroblasts from heterozygous (74 ± 8 pmol of O2/min) and homozygous (58 ± 12 pmol of O2/min) dogs was significantly lower than that for dogs without PDK4 mutation (115 ± 9 pmol of O2/min). After AAV transduction, OCR did not increase significantly in any group (mutation-free group, 121 ± 26 pmol of O2/min; heterozygous group, 88 ± 6 pmol of O2/min; homozygous group, 59 ± 3 pmol of O2/min). Mitochondrial function was altered in skin fibroblasts of Doberman Pinschers with DCM and PDK4 mutation. Change in mitochondrial function after in vitro gene therapy at the multiplicities of infection used in this study was not significant.

  1. Beneficial effect of azathioprine and prediction of prognosis in primary biliary cirrhosis. Final results of an international trial.

    PubMed

    Christensen, E; Neuberger, J; Crowe, J; Altman, D G; Popper, H; Portmann, B; Doniach, D; Ranek, L; Tygstrup, N; Williams, R

    1985-11-01

    The effect of azathioprine on survival of patients with primary biliary cirrhosis was studied prospectively in a multinational, double-blind, randomized clinical trial including 248 patients of whom 127 received azathioprine and 121 placebo. There were 57 deaths in the azathioprine group and 62 in the placebo group. The actual survival was slightly longer during azathioprine than during placebo treatment. Using Cox multiple regression analysis and adjusting for slight imbalance between the two treatment groups, the therapeutic effect of azathioprine was statistically significant (p = 0.01), with azathioprine reducing the risk of dying to 59% of that observed during placebo treatment (95% confidence interval 40%-90%) or improving survival time by 20 mo in the average patient. Furthermore, azathioprine slowed down progressing incapacitation. Side effects of azathioprine were relatively few. The analysis revealed that the following five variables independently implied poor prognosis: high serum bilirubin, old age, cirrhosis, low serum albumin, and central cholestasis. These factors were combined to a "prognostic index" for prediction of outcome in new patients. The index was validated on independent patient data. On the basis of these results we recommend azathioprine as a routine treatment of primary biliary cirrhosis.

  2. Could conscious sedation with midazolam for dental procedures be an alternative to general anesthesia?

    PubMed

    Silay, E; Candirli, C; Taskesen, F; Coskuner, I; Ceyhanli, K T; Yildiz, H

    2013-01-01

    The aim of our study was to evaluate the likelihood that conscious sedation (CS) with intravenous midazolam could become an alternative modality to general anesthesia (GA) for dental procedures. In our study, 58 and 47 American Society of Anesthesiologists (ASA)-1 pediatric patients, aged 2-12 (mean 6) years, underwent dental procedures and minor oral surgical procedures under GA and CS with intravenous midazolam, respectively. The two groups were evaluated in terms of vital signs, duration of the treatment procedure, patient behavior, and the treatment comfort experienced by the physicians. The oxygen saturation level was significantly lower (GA: 99.0 ± 0.30, CS: 98.4 ± 1.02; P < 0.001) and the duration of the treatment procedure was significantly shorter (P < 0.001) in the sedation group compared with the GA group. The physicians encountered various difficulties during implementation of the treatment strategy in cases where they used CS. Minor oral surgical procedures and tooth extraction processes requiring no saline irrigation, however, could be performed successfully under CS. In cases requiring multiple dental management issues, the sedation method was not found to be a useful alternative to GA.

  3. Preventing dengue through mobile phones: evidence from a field experiment in Peru.

    PubMed

    Dammert, Ana C; Galdo, Jose C; Galdo, Virgilio

    2014-05-01

    Dengue is the most rapidly spreading mosquito-borne viral disease in the world (WHO, 2009). During the last two decades, the dramatic rise in the number of dengue infections has been particularly evident in Latin American and the Caribbean countries. This paper examines the experimental evidence of the effectiveness of mobile phone technology in improving households' health preventive behavior in dengue-endemic areas. The main results suggest that repeated exposure to health information encourages households' uptake of preventive measures against dengue. As a result, the Breteau Index in treatment households, an objective measure of dengue risk transmission, is 0.10 standard deviations below the mean of the control group, which shows a reduction in the number of containers per household that test positive for dengue larvae. The estimates also show marginally significant effects of the intervention on self-reported dengue symptoms. Moreover, we use a multiple treatment framework that randomly assigns households to one of the four treatment groups in order to analyze the impacts of framing on health behavior. Different variants emphasized information on monetary and non-monetary benefits and costs. The main results show no statistical differences among treatment groups. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. Manual for the psychotherapeutic treatment of acute and post-traumatic stress disorders following multiple shocks from implantable cardioverter defibrillator (ICD)

    PubMed Central

    Jordan, Jochen; Titscher, Georg; Peregrinova, Ludmila; Kirsch, Holger

    2013-01-01

    Background: In view of the increasing number of implanted cardioverter defibrillators (ICD), the number of people suffering from so-called “multiple ICD shocks” is also increasing. The delivery of more than five shocks (appropriate or inappropriate) in 12 months or three or more shocks (so called multiple shocks) in a short time period (24 hours) leads to an increasing number of patients suffering from severe psychological distress (anxiety disorder, panic disorder, adjustment disorder, post-traumatic stress disorder). Untreated persons show chronic disease processes and a low rate of spontaneous remission and have an increased morbidity and mortality. Few papers have been published concerning the psychotherapeutic treatment for these patients. Objective: The aim of this study is to develop a psychotherapeutic treatment for patients with a post-traumatic stress disorder or adjustment disorder after multiple ICD shocks. Design: Explorative feasibility study: Treatment of 22 patients as a natural design without randomisation and without control group. The period of recruitment was three years, from March 2007 to March 2010. The study consisted of two phases: in the first phase (pilot study) we tested different components and dosages of psychotherapeutic treatments. The final intervention programme is presented in this paper. In the second phase (follow-up study) we assessed the residual post-traumatic stress symptoms in these ICD patients. The time between treatment and follow-up measurement was 12 to 30 months. Population: Thirty-one patients were assigned to the Department of Psychocardiology after multiple shocks. The sample consisted of 22 patients who had a post-traumatic stress disorder or an adjustment disorder and were willing and able to participate. They were invited for psychological treatment. 18 of them could be included into the follow-up study. Methods: After the clinical assessment at the beginning and at the end of the inpatient treatment a post-treatment assessment with questionnaires followed. In this follow-up measurement, minimum 12 months after inpatient treatment, posttraumatic stress was assessed using the “Impact of Event Scale” (IES-R). Setting: Inpatient treatment in a large Heart and Thorax Centre with a Department of Psychocardiology (Kerckhoff Heart Centre). Results: From the 18 patients in the follow-up study no one reported complaints of PTSD. 15 of them reported a high or even a very high decrease of anxiety and avoidance behaviour. Conclusions: The fist step of the treatment development seems to be successful. It shows encouraging results with an acceptable dosage. The second step of our work is in process now: we evaluate the treatment manual within other clinical institutions and a higher number of psychotherapists. This leads in the consequence to a controlled and randomised comparison study. PMID:24403967

  5. Effects of hippotherapy in multiple sclerosis: pilot study on quality of life, spasticity, gait, pelvic floor, depression and fatigue.

    PubMed

    Muñoz-Lasa, Susana; López de Silanes, Carlos; Atín-Arratibel, M Ángeles; Bravo-Llatas, Carmen; Pastor-Jimeno, Salvador; Máximo-Bocanegra, Nuria

    2018-04-19

    Hippotherapy is being used as a promising method in the physical treatment of multiple sclerosis (MS). Comparative open clinical pre-post study into hippotherapy intervention during a 6-month period in patients with MS (n=6). Not randomised and with control group (n=4). The study was performed by MHG Foundation. A statistically significant improvement was observed in the therapy group in: spasticity pre-post measured by the modified Ashworth scale (P=.01). Statistically significant improvement in fatigue impact (P<.0001) measured with FIS; in general, perception of heath outcome in urinary quality of life scale KHQ (P=.033), and in subscales 2, 3 and 4 of MSQOL-54 (P=.011). Control group showed no improvement in any scale. This study reinforces current literature that supports hippotherapy as an adequate intervention for MS patients. Further studies with more participants, control groups and blinded research would be logical steps for future research in this field. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

  6. The cam impinging femur has multiple morphologic abnormalities.

    PubMed

    Ellis, Andrew R; Noble, Philip C; Schroder, Steven J; Thompson, Matthew T; Stocks, Gregory W

    2011-09-01

    This study was performed to establish whether the "cam" impinging femur has a single deformity of the head-neck junction or multiple abnormalities. Average dimensions (anteversion angle, α angle of Notzli, β angle of Beaulé, normalized anterior head offset) were compared between normal and impinging femora. The results demonstrated that impinging femora had wider necks, larger heads, and decreased head-neck ratios. There was no difference in neck-shaft angle or anteversion angle. Forty-six percent of impinging femora had significant posterior head displacement (>2mm), which averaged 1.93 mm for the cam impinging group, and 0.78 mm for the normal group. In conclusion, surgical treatment limited to localized recontouring of the head-neck profile may fail to address significant components of the underlying abnormality. Copyright © 2011 Elsevier Inc. All rights reserved.

  7. The motivation, skills, and decision-making model of "drug abuse" prevention.

    PubMed

    Sussman, Steve; Earleywine, Mitchell; Wills, Thomas; Cody, Christine; Biglan, Tony; Dent, Clyde W; Newcomb, Michael D

    2004-01-01

    This article summarizes the theoretical basis for targeted prevention programs as they apply to different high-risk groups. We explain the advantages and disadvantages of different definitions of risk and discuss strategies for preventing drug use related problems in high-risk youth. Productive prevention programs for many at-risk groups share similar components, including those that address motivation, skills, and decision making. We present key aspects of these three components and link them to theories in clinical psychology, social psychology, sociology, and chemical dependence treatment. Among a total of 29 promising targeted prevention programs, we describe examples of empirically evaluated, intensive interventions that have made a positive impact on the attitudes and behavior of multiple problem youth. Incorporating the perspectives of multiple disciplines appears essential for progress in drug abuse and other problem behavior prevention.

  8. Patient engagement and attrition in pediatric obesity clinics and programs: results and recommendations.

    PubMed

    Hampl, Sarah; Paves, Heather; Laubscher, Katie; Eneli, Ihuoma

    2011-09-01

    Pediatric tertiary care institutions are well positioned to provide multidisciplinary, intensive interventions for pediatric obesity known as stage 3 treatment. One contributor to the difficulty in administering this treatment is the high rate of patient attrition. Little is known about the practices used by pediatric weight-management clinics and group-based programs to minimize attrition. Hospital members and nonmembers of FOCUS on a Fitter Future were surveyed on the methods used to engage and retain obese children in their clinics and programs. Shortly thereafter, a benchmarking activity that centered on rates of patient nonattendance at initial and follow-up clinic visits was initiated among FOCUS-group-participating hospitals. Clinic- and group-based program results were contrasted. Staff from group-based programs reported that the majority of patients did not complete even 50% of program follow-up visits. Multiple patient/family- and clinic/program-level barriers to retention were identified. Attention to successful techniques should be paid during planning for new programs and improvement of established ones.

  9. Comparison of clinical characteristics among narcolepsy with and without cataplexy and idiopathic hypersomnia without long sleep time, focusing on HLA-DRB1( *)1501/DQB1( *)0602 finding.

    PubMed

    Sasai, Taeko; Inoue, Yuichi; Komada, Yoko; Sugiura, Tatsuki; Matsushima, Eisuke

    2009-10-01

    Clinical characteristics of narcolepsy without cataplexy (NA w/o CA) and its relation to positivity of HLA-DRB1( *)1501/DQB1( *)0602 remain unclarified. We investigated clinical features of NA w/o CA, particularly addressing HLA-DRB1( *)1501/DQB1( *)0602. Comparisons of the Epworth Sleepiness Scale (ESS), multiple sleep latency test (MSLT) variables, rapid eye movement (REM)-related symptoms, and treatment response to psychostimulant medication were made for four patient groups (narcolepsy with cataplexy; NA-CA, NA w/o CA HLA-positive, NA w/o CA HLA-negative, and idiopathic hypersomnia without long sleep time; IHS w/o LST). Mean sleep latency was significantly shorter and the rate of reduction of ESS after medication was lower in both NA-CA and NA w/o CA HLA-positive groups than those in the IHS w/o LST group. Among the three narcoleptic groups, the NA w/o CA HLA-negative group showed the lowest REM latency and the highest reduction rate of ESS after treatment. Neither these subjective and objective sleepiness measures nor the treatment response measure was significantly different between this group and the IHS w/o LST group. In NA w/o CA, HLA-positivity might affect hypersomnia severity and REM propensity. The NA w/o CA HLA-negative group and the IHS w/o LST group exhibit equivalent hypersomnia severity.

  10. Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

    PubMed

    Huang, DeRen

    2015-12-01

    The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

  11. Changes in Th17 cells function after nanocurcumin use to treat multiple sclerosis.

    PubMed

    Dolati, Sanam; Ahmadi, Majid; Rikhtegar, Reza; Babaloo, Zohreh; Ayromlou, Hormoz; Aghebati-Maleki, Leili; Nouri, Mohammad; Yousefi, Mehdi

    2018-05-28

    MS is a chronic inflammatory disease that causes to brain inflammation and Th17 cells are considered to be important in multiple sclerosis pathogenesis. In the current study, we aimed to identify nanocurcumin effects on Th17 cells frequency, cytokines secretion, and expression of transcription factor of patients with relapsing-remitting multiple sclerosis (RRMS). In this study we investigated frequency of Th17 lymphocytes; the expression of transcription factor, associated cytokines and the concentration of them in 35 healthy controls, and from 25 patients at baseline and after 6 months of nanocurcumin treatment and also from 25 patients whose received placebo by flowcytometry, real-time PCR and ELISA, respectively. Our analysis revealed that the proportions of Th17 were increased dramatically, along with increases in the levels of IL-17A, IL-23, and RORγt expression in MS patients in compared with healthy control group. Post-treatment evaluation of the nanocurcumin group revealed a significant decrease in Th17 associated parameters such as Th17 frequency (p = 0.029), expression levels of RORγt (p < 0.0001) and IL-17 (p = 0.0044) and also secretion level of IL-17 (p = 0.0011), but IL-23 mRNA expression levels and IL-23 concentration were not influenced by nanocurcumin. However, in the placebo group there is no significant changes in these factors. Our study suggests that the increase in proportion of Th17 cells might contribute to the pathogenesis of RRMS. The results of the current work indicated that nanocurcumin is able to restore the dysregulated of Th17 cells in MS patients. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. The Effect of Orem’s Self-Care Model on Fatigue in Patients With Multiple Sclerosis: A Single Blind Randomized Clinical Trial Study

    PubMed Central

    Afrasiabifar, Ardashir; Mehri, Zahra; Javad Sadat, Saied; Ghaffarian Shirazi, Hamid Reza

    2016-01-01

    Background Orem’s self-care model is a nursing model that was introduced with the purpose of improving the self-care of individuals, especially patients suffering from chronic diseases. Objectives To determining the effect of Orem’s self-care model on fatigue in multiple sclerosis patients. Patients and Methods This research involved a clinical trial. Sixty-three multiple sclerosis patients at the vice-chancellor in treatment affairs of Yasuj University of Medical Sciences were selected based on nonrandom sampling, but they were allocated to the two groups based on random allocation. In the intervention group, Orem’s model was applied during six sessions of 45 - 60 minutes in length, and the process continued for 1 month. The data were collected 1 week before and 7 weeks after the end of the intervention using the Orem’s self-care model-based assessment form and fatigue severity scale, the validity and reliability of which have been Results Before the intervention, 11.11% of the participants had a good knowledge of self-care. In addition, self-care willingness and skills were observed in 76.19% and 4.76% of participants, respectively. The mean difference in fatigue reduced significantly in the intervention group after the intervention (P < 0.05). After the intervention, a statistically significant difference was observed in the mean difference of fatigue between the two groups (P < 0.05). Conclusions Orem’s self-care model is significantly effective in reducing the fatigue of multiple sclerosis patients. PMID:27781119

  13. Short-term nanostructural effects of high radiofrequency treatment on the skin tissues of rabbits.

    PubMed

    Choi, Samjin; Cheong, Youjin; Shin, Jae-Ho; Lee, Hui-Jae; Lee, Gi-Ja; Choi, Seok Keun; Jin, Kyung-Hyun; Park, Hun-Kuk

    2012-09-01

    The aim of this study is to quantitatively investigate the short-term effects of RF tissue-tightening treatment in in vivo rabbit dermal collagen fibrils. These effects were measured at different energy levels and at varying pass procedures on the nanostructural response level using histology and AFM analysis. Each rabbit was divided into one of seven experimental groups, which included the following: control group, and six RF group according to RF energy (20 W and 40 W) and three RF pass procedures. The progressive changes in the diameter and D-periodicity of rabbit dermal collagen fibrils were investigated in detail over a 7-day post-treatment period. The dermal tissues treated with the RF tissue-tightening device showed more prominent inflammatory responses with inflammatory cell ingrowth compared to the control. This effect showed more prominent with the passage of day after treatment. Although an increase in the diameter and D-periodicity of dermal collagen fibrils was identified immediately after the RF treatment, a decrease in the morphology of dermal collagen fibrils continued until post-operative day 7. Furthermore, RF treatment led to the loss of distinct borders. Increases in RF energy with the same pass procedure, as well as an increase in the number of RF passes, increased the occurrence of irreversible collagen fibril injury. A multiple-pass treatment at low energy rather than a single-pass treatment at high energy showed a large amount of collagen fibrils contraction at the nanostructural level.

  14. Effect size calculation in meta-analyses of psychotherapy outcome research.

    PubMed

    Hoyt, William T; Del Re, A C

    2018-05-01

    Meta-analysis of psychotherapy intervention research normally examines differences between treatment groups and some form of comparison group (e.g., wait list control; alternative treatment group). The effect of treatment is normally quantified as a standardized mean difference (SMD). We describe procedures for computing unbiased estimates of the population SMD from sample data (e.g., group Ms and SDs), and provide guidance about a number of complications that may arise related to effect size computation. These complications include (a) incomplete data in research reports; (b) use of baseline data in computing SMDs and estimating the population standard deviation (σ); (c) combining effect size data from studies using different research designs; and (d) appropriate techniques for analysis of data from studies providing multiple estimates of the effect of interest (i.e., dependent effect sizes). Clinical or Methodological Significance of this article: Meta-analysis is a set of techniques for producing valid summaries of existing research. The initial computational step for meta-analyses of research on intervention outcomes involves computing an effect size quantifying the change attributable to the intervention. We discuss common issues in the computation of effect sizes and provide recommended procedures to address them.

  15. Heart Rate Changes in Electroacupuncture Treated Polycystic Ovary in Rats.

    PubMed

    Ramadoss, Mukilan; Ramanathan, Gunasekaran; Subbiah, Angelie Jessica; Natrajan, Chidambaranathan

    2016-03-01

    Polycystic Ovary Syndrome (PCOS) is a common metabolic disorder, it affects both humans and animals. It may induce coronary heart disease, obesity and hyperandrogenism. Previous studies show that Low frequency Electroacupuncture (EA) have an effect on PCOS, however the exact pathway is unclear. To find the effect of EA on autonomic activity of the heart in Estradiol Valerate (EV) induced PCOS rats. Heart rate variability (HRV) was assessed in 3 groups: 1) Control; 2) PCOS rats; and 3) PCOS rats after EA treatment (n=8 in each group). From the time domain analysis and frequency domain analysis (linear measures) HRV analysis was done. EA stimulation was given at low frequency of 2Hz for 15 min on alternate days for 4-5 weeks. Collected data were statistically analysed using One-Way Analysis of Variance with the application of multiple comparisons of Tukey test. EA treatment group shows significant reduction in Heart Rate (HR) and low frequency, high frequency ratio (LF/HF); and increase in RR interval, Total Power (TP) when compared to PCOS group. The study concludes that EA treatment has a significant effect on reducing sympathetic tone and decreasing HR in PCOS.

  16. Measuring chronic pain intensity among veterans in a residential rehabilitation treatment program.

    PubMed

    Randleman, Mary L; Douglas, Mary E; DeLane, Alice M; Palmer, Glen A

    2014-01-01

    The purpose of this study was to identify whether veterans with chronic pain, substance abuse, and posttraumatic stress disorder (PTSD) diagnoses residing in a Residential Rehabilitation Treatment Program (RRTP) perceived a higher level of pain than those veterans who had chronic pain but did not have active substance abuse issues or PTSD. A sample of veterans (n = 200) with chronic pain undergoing treatment for either chemical dependency and/or PTSD in an RRTP and a Surgical Specialty Care outpatient clinic at a Department of Veterans Affairs medical center took part in the study. Multiple analysis of variance and further univariate statistics were examined to determine the association between groups on the different scales. There was a considerable difference in terms of which group of veterans perceived a higher rate of pain even with the use of the same four pain assessment scales (i.e., Numeric Rating, Visual Analog, Faces, and Mankoski). Scores were significantly higher for the RRTP group than the Surgical Specialty Care group on all screening measures (p < .001). Veterans with chronic pain, substance abuse, and/or PTSD diagnoses residing in an RRTP tended to have a higher perception of chronic pain compared to those without substance abuse or PTSD diagnoses.

  17. The costs and consequences of assisted reproductive technology: an economic perspective.

    PubMed

    Connolly, Mark P; Hoorens, Stijn; Chambers, Georgina M

    2010-01-01

    Despite the growing use of assisted reproductive technologies (ART) worldwide, there is only a limited understanding of the economics of ART to inform policy about effective, safe and equitable financing of ART treatment. A review was undertaken of key studies regarding the costs and consequences of ART treatment, specifically examining the direct and indirect costs of treatment, economic drivers of utilization and clinical practice and broader economic consequences of ART-conceived children. The direct costs of ART treatment vary substantially between countries, with the USA standing out as the most expensive. The direct costs generally reflect the costliness of the underlying healthcare system. If unsubsidized, direct costs represent a significant economic burden to patients. The level of affordability of ART treatment is an important driver of utilization, treatment choices, embryo transfer practices and ultimately multiple birth rates. The costs associated with caring for multiple-birth ART infants and their mothers are substantial, reflecting the underlying morbidity associated with such pregnancies. Investment analysis of ART treatment and ART-conceived children indicates that appropriate funding of ART services appears to represent sound fiscal policy. The complex interaction between the cost of ART treatment and how treatments are subsidized in different healthcare settings and for different patient groups has far-reaching consequences for ART utilization, clinical practice and infant outcomes. A greater understanding of the economics of ART is needed to inform policy decisions and to ensure the best possible outcomes from ART treatment.

  18. Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

    PubMed

    Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

    2017-02-01

    To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( P<0.01). This pilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

  19. Effect of alpha-lipoic acid on asymmetric dimethylarginine and disability in multiple sclerosis patients: A randomized clinical trial.

    PubMed

    Khalili, Mohammad; Soltani, Madjid; Moghadam, Shirin Amiri; Dehghan, Parvin; Azimi, Amirreza; Abbaszadeh, Omid

    2017-07-01

    Multiple Sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system. Oxidative stress plays a major role in the onset and progression of MS. Asymmetric dimethylarginine (ADMA) formation is dependent on oxidative stress status. We examined whether alpha-lipoic acid (ALA) as a potent antioxidant could improve the Expanded Disability Status Scale (EDSS) and decrease plasma level of ADMA in multiple sclerosis patients. In a randomized, double-blinded clinical trial conducted at Sina Hospital in Tehran, Iran, from September 2009 to July 2011, 24 patients with relapsing-remitting MS were divided into a treatment group receiving ALA (1200mg/day) for 12 weeks and a control group receiving placebo. Then patients' EDSS and Plasma levels of ADMA were measured at baseline and 12 weeks later. Statistical analysis was done by SPSS software version 16 using the K-S test, Chi square, Mann-Whitney U-test and Wilcoxon test. The plasma levels of ADMA in the intervention group were decreased significantly (p=0.04). Also, no patient had increased EDSS score in the supplement group, where 2 out of 12 patients in the placebo group experienced so. Comparing the serum level of ADMA between the two groups failed to show any significant change in the supplement group compared with the control group. Considering that ADMA is produced by oxidative stress in MS patients and leads to increase of inflammation, ALA may have the potential of beneficial effects in them, in part, by decreasing the plasma level of ADMA and stopping progression. The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: No. IRCT138812222602N2. The authors received no financial support for the research, authorship, and/or publication of this article.

  20. Antitumor Effect of GO-PEG-DOX Complex on EMT-6 Mouse Breast Cancer Cells.

    PubMed

    Yan, Jinyin; Song, Bo; Hu, Wanning; Meng, Ying; Niu, Fengling; Han, Xiaochen; Ge, Yuhui; Li, Ning

    2018-05-01

    Doxorubicin (DOX) can be used to treat malignant tumors, but with multiple adverse effects. Graphene oxide-polyethylene glycol (GO-PEG) is a novel nanoscale carrier material and can elevate solubility and biocompatibility of drugs. This study prepared a GO-PEG-DOX complex, whose toxicity and antitumor effects were evaluated on mouse EMT-6 breast cancer cells. GO-PEG-DOX complex was prepared for calculating the drug carrier rate of DOX on GO-PEG by MV approach. EMT-6 cells were treated with 40 μg/mL GO-PEG, 1 μg/mL DOX, or 40 μg/mL +1 μg/mL GO-PEG-DOX for 72 h of incubation. Cells without treatment were considered the control group. Cell survival rate and apoptotic rate were tested at different time points. GO-PEG and GO-PEG-DOX complex were successfully prepared with satisfactory solubility. After 72 h of incubation, EMT-6 cells after GO-PEG-DOX treatment had significantly higher survival rate than GO-PEG group (p < 0.05). All three treatment groups had significantly elevated apoptotic rates than control group (p < 0.05). GO-PEG-DOX group had much more apoptosis (p < 0.05 compared with DOX group). Moreover, with elongated treatment time, all groups showed decreased survival rate (p < 0.05). GO-PEG did not reduce the cytotoxicity of DOX on EMT-6 cells. GO-PEG-DOX complex can increase the water solubility and targeting sensitivity of DOX, with facilitating effects on DOX-induced tumor cell apoptosis.

  1. Characteristics of Rosai-Dorfman Disease Primarily Involved in the Central Nervous System: 3 Case Reports and Review of Literature.

    PubMed

    Luo, Zhengxiang; Zhang, Yansong; Zhao, Penglai; Lu, Hucheng; Yang, Kun; Zhang, Yuhai; Zeng, Yanjun

    2017-01-01

    This study aimed to summarize the clinical characteristics of Rosai-Dorfman disease primarily involving the central nervous system and to explore diagnosis and treatment. We analyzed the clinical, imaging, and pathologic characteristics; treatment; and prognosis in 3 cases of Rosai-Dorfman disease primarily involving the central nervous system. We also performed a literature review. The largest of multiple intracranial lesions was totally resected, and steroid administration and radiotherapy were performed in phases for the remaining lesions. During the 1-year follow-up period, the excised lesion did not recur, and no obvious variations were observed in the other lesions. Subtotal resection was performed of the largest of another group of multiple intracranial lesions, and the residual did not show any obvious variations during the 1-year follow-up period. The isolated lesion was totally resected and did not recur during a 2-year follow-up period. Rosai-Dorfman disease with multiple lesions primarily involving the central nervous system is rare. Imaging characteristics are similar to meningiomas, and the pathological features include lymphocytes and plasma cells reaching tissue cells with large volume and abundant cytoplasm. Surgery is the preferred treatment, as the effects of steroid administration and radiotherapy are not apparent. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. MRI study of the cuprizone-induced mouse model of multiple sclerosis: demyelination is not found after co-treatment with polyprenols (long-chain isoprenoid alcohols)

    NASA Astrophysics Data System (ADS)

    Khodanovich, M.; Glazacheva, V.; Pan, E.; Akulov, A.; Krutenkova, E.; Trusov, V.; Yarnykh, V.

    2016-02-01

    Multiple sclerosis is a neurological disorder with poorly understood pathogenic mechanisms and a lack of effective therapies. Therefore, the search for new MS treatments remains very important. This study was performed on a commonly used cuprizone animal model of multiple sclerosis. It evaluated the effect of a plant-derived substance called Ropren® (containing approximately 95% polyprenols or long-chain isoprenoid alcohols) on cuprizone- induced demyelination. The study was performed on 27 eight-week old male CD-1 mice. To induce demyelination mice were fed 0.5% cuprizone in the standard diet for 10 weeks. Ropren® was administered in one daily intraperitoneal injection (12mg/kg), beginning on the 6th week of the experiment. On the 11th week, the corpus callosum in the brain was evaluated in all animals using magnetic resonance imaging with an 11.7 T animal scanner using T2- weighted sequence. Cuprizone treatment successfully induced the model of demyelination with a significant decrease in the size of the corpus callosum compared with the control group (p<0.01). Mice treated with both cuprizone and Ropren® did not exhibit demyelination in the corpus callosum (p<0.01). This shows the positive effect of polyprenols on cuprizone-induced demyelination in mice.

  3. "One for Sorrow, Two for Joy?": American embryo transfer guideline recommendations, practices, and outcomes for gestational surrogate patients.

    PubMed

    White, Pamela M

    2017-04-01

    In January 2016, Melissa Cook, a California gestational surrogate experiencing a multiple-birth pregnancy following the in vitro fertilization (IVF) transfer of three embryos comprised of donor eggs and sperm provided by the intended father, went to the media when the intended father requested that she undergo a fetal reduction because twins were less expensive to raise than triplets. Much of the legal interest in this case to date has centered on the enforceability of surrogacy contracts. However, the Cook case also raises troubling issues about fertility treatment practices involving gestational surrogates, twin preference, and third-party reproduction medical decision-making. This paper focuses on multiple-embryo transfers in the context of US surrogacy arrangements. Offering an original analysis of data obtained from the US national-assisted reproduction registry, it examines single- and multiple-embryo transfer trends over a 12-year period (2003 to 2014). Findings reveal that recommended guidelines were followed in fewer than 42% of the cases in 2014. The paper argues that ensuring equitable medical treatment for all recipients of IVF requires the adoption of treatment guidelines tailored to, and offering protections for, specific patient groups, and that, once in place, guidelines must be robustly implemented.

  4. Disparities in breast cancer treatment and outcomes: biological, social, and health system determinants and opportunities for research.

    PubMed

    Wheeler, Stephanie B; Reeder-Hayes, Katherine E; Carey, Lisa A

    2013-01-01

    Racial disparities in breast cancer mortality have been widely documented for several decades and persist despite advances in receipt of mammography across racial groups. This persistence leads to questions about the roles of biological, social, and health system determinants of poor outcomes. Cancer outcomes are a function not only of innate biological factors but also of modifiable characteristics of individual behavior and decision making as well as characteristics of patient-health system interaction and the health system itself. Attempts to explain persistent racial disparities have mostly been limited to discussion of differences in insurance coverage, socioeconomic status, tumor stage at diagnosis, comorbidity, and molecular subtype of the tumor. This article summarizes existing literature exploring reasons for racial disparities in breast cancer mortality, with an emphasis on treatment disparities and opportunities for future research. Because breast cancer care requires a high degree of multidisciplinary team collaboration, ensuring that guideline recommended treatment (such as endocrine therapy for hormone receptor positive patients) is received by all racial/ethnic groups is critical and requires coordination across multiple providers and health care settings. Recognition that variation in cancer care quality may be correlated with race (and socioeconomic and health system factors) may assist policy makers in identifying strategies to more equally distribute clinical expertise and health infrastructure across multiple user populations.

  5. Review of multiple-choice-questions and group performance - A comparison of face-to-face and virtual groups with and without facilitation

    PubMed Central

    Kazubke, Edda; Schüttpelz-Brauns, Katrin

    2010-01-01

    Background: Multiple choice questions (MCQs) are often used in exams of medical education and need careful quality management for example by the application of review committees. This study investigates whether groups communicating virtually by email are similar to face-to-face groups concerning their review process performance and whether a facilitator has positive effects. Methods: 16 small groups of students were examined, which had to evaluate and correct MCQs under four different conditions. In the second part of the investigation the changed questions were given to a new random sample for the judgement of the item quality. Results: There was no significant influence of the variables “form of review committee” and “facilitation”. However, face-to-face and virtual groups clearly differed in the required treatment times. The test condition “face to face without facilitation” was generally valued most positively concerning taking over responsibility, approach to work, sense of well-being, motivation and concentration on the task. Discussion: Face-to-face and virtual groups are equally effective in the review of MCQs but differ concerning their efficiency. The application of electronic review seems to be possible but is hardly recommendable because of the long process time and technical problems. PMID:21818213

  6. A 10-year trend of dental treatments under general anesthesia of children in Taipei Veterans General Hospital.

    PubMed

    Chen, Yung-Pan; Hsieh, Chun-Yi; Hsu, Wen-Ting; Wu, Fu-Ya; Shih, Wen-Yu

    2017-04-01

    General anesthesia (GA) as a pediatric dental procedure is a well-established method of behavior management. However, studies of pediatric dentistry under GA have mostly focused on handicapped patients, and various retrospective studies in Taiwan have mainly reviewed only a limited number of years. The purpose of the present study was to report trends in pediatric dental treatment performed under GA over the past 10 years. A retrospective review of the hospital records of patients receiving dental treatment under GA from 2006 until 2015 was performed. The patients were divided into three age groups: < 3 years, 3-6 years, and > 6 years. A range of information including basic patient characteristics and types of dental treatment was identified and then analyzed. A total of 791 cases (< 3 years old: 65 cases, 3-6 years old: 492, > 6 years old: 235; 549 male, 242 female) were treated under GA. The case number was found to have increased from 94 during 2006-2007 to 238 during 2014-2015, with the increase being especially pronounced among those aged 3-6 years (2006-2007: 49, 2014-2015: 165). The most common treatments (extraction, restoration, and pulp therapy) were associated with multiple dental caries (684, 86.4%). The < 3-years-old group was characterized by the highest decayed, extracted, and filled surface and decayed, missing, and filled surface indices; the highest mean number of treated teeth; and the highest mean number of treated teeth by composite resin fillings. The 3-6-years-old group had the highest number of primary teeth extractions. The > 6-years-old group had the lowest mean number of treated teeth by stainless-steel crowns (SSCs) and fewest cases treated with pulp therapy. From 2011 onwards, the number of primary tooth extractions significantly increased, while in 2013, there was a crossover whereby the SSC count surpassed the composite resin filling count. Over the past 10 years, there has been an increased use of GA for pediatric dental treatments, in particular, in cases with multiple dental caries. In addition, there has also been an increasing trend towards extraction of primary teeth and the use of SSCs. Copyright © 2017. Published by Elsevier Taiwan LLC.

  7. Light chains removal by extracorporeal techniques in acute kidney injury due to multiple myeloma: a position statement of the Onconephrology Work Group of the Italian Society of Nephrology.

    PubMed

    Fabbrini, P; Finkel, K; Gallieni, M; Capasso, G; Cavo, M; Santoro, A; Pasquali, S

    2016-12-01

    Acute kidney injury (AKI) is a frequent complication of multiple myeloma and is associated with increased short-term mortality. Additionally, even a single episode of AKI can eventually lead to end-stage renal disease (ESRD), significantly reducing quality of life and long-term survival. In the setting of multiple myeloma, severe AKI (requiring dialysis) is typically secondary to cast nephropathy (CN). Renal injury in CN is due to intratubular obstruction from precipitation of monoclonal serum free light chains (sFLC) as well as direct tubular toxicity of sFLC via stimulation of nuclear factor (NF)κB inflammatory pathways. Current mainstays of CN treatment are early removal of precipitating factors such as nephrotoxic drugs, acidosis and dehydration, together with rapid reduction of sFLC levels. Introduction of the proteasome inhibitor bortezomib has significantly improved the response rates in multiple myeloma due to its ability to rapidly reduce sFLC levels and has been referred to as "renoprotective" therapy. As an adjunct to chemotherapy, several new extracorporeal techniques have raised interest as a further means to reduce sFLC concentrations in the treatment of CN. Whether addition of extracorporeal therapies to renoprotective therapy can result in better renal recovery is still a matter of debate and there are currently no guidelines in this field. In this positon paper, we offer an overview of the available data and the authors' perspectives on extracorporeal treatments in CN.

  8. Analysis of buprenorphine/naloxone dosing impact on treatment duration, resource use and costs in the treatment of opioid-dependent adults: a retrospective study of US public and private health care claims.

    PubMed

    Khemiri, Amine; Kharitonova, Elizaveta; Zah, Vladimir; Ruby, Jane; Toumi, Mondher

    2014-09-01

    The buprenorphine/naloxone combination is used to treat the chronic relapsing disorder of opioid dependence. Adequate dosing levels are important to control cravings, prevent withdrawal syndrome, and maintain patients in treatment. The objective of this study was to estimate the impact of dosing on treatment persistence, resource utilization, and total direct health care costs. A retrospective cohort analysis was performed using administrative claims extracted from the MarketScan and Clinformatics databases from January 2007 to June and November 2012. Patients initiating treatment with buprenorphine/naloxone were classified into 2 groups based on the prescribed average dose over the entire treatment period and matched by multiple criteria. The threshold for differentiating the dosing groups was set at 15 and 15.7 mg/day for publicly and privately insured patients, respectively. Resource utilization and related costs were calculated over the 12-month period after the treatment initiation. Patient characteristics at baseline were considerably different between the privately and publicly insured patients. Publicly insured patients were slightly younger (33.1 vs 34.3 years old for privately insured) and had a higher prevalence of mental disorders (70.9% vs 64.9%). In both groups, patients treated with higher doses (> 15 mg and > 15.7 mg per day for publicly and privately insured patients, respectively) had lower risk of discontinuation (public: 11% lower; private: 9% lower) and lower probability of a psychiatric hospitalization than patients treated with lower doses (public: 17% lower; private: 41% lower). Total costs were comparable between the 2 groups (public: $14 600; private: $21 000) despite the expected higher cost of pharmacy in the higher-dose group. Treatment with higher doses of buprenorphine/naloxone was associated with a longer time to treatment discontinuation, less resource use, and lower total medical costs despite higher pharmacy acquisition cost.

  9. Peer Attachment, Perceived Parenting Style, Self-concept, and School Adjustments in Adolescents with Chronic Illness.

    PubMed

    Ahn, Jeong-Ah; Lee, Sunhee

    2016-12-01

    The purpose of this study was to identify how peer attachment and parenting style differentially affect self-concept and school adjustment in adolescents with and without chronic illness. A cross-sectional study using multiple group analysis on the Korean panel data was used. A nationwide stratified multistage cluster sampling method was used and the survey was conducted in 2013 on 2,092 first-year middle school students in Korea. We used standardized instruments by the National Youth Policy Institute to measure peer attachment, parenting style, self-concept, and school adjustment. Multiple-group structural equation modeling was used to evaluate the difference of relations for peer attachment, parenting style, self-concept, and school adjustment variable between adolescents with chronic illness and those without chronic illness. The model fit of a multiple-group structural equation modeling was good. The difference of the path from negative parenting style to self-concept between the two groups was significant, and a significant between-group difference in the overall path was found. This indicated that self-concept in adolescents with chronic illness was more negatively affected by negative parenting style than in adolescents without chronic illness. Healthcare providers can promote the process of school adjustment in several ways, such as discussing this issue directly with adolescent patients, along with their parents and peers, examining how the organization and content of the treatment can be modified according to the adolescents' school life. Copyright © 2016. Published by Elsevier B.V.

  10. Feedback mechanisms of change: How problem alerts reported by youth clients and their caregivers impact clinician-reported session content

    PubMed Central

    Douglas, Susan R.; Jonghyuk, Bae; de Andrade, Ana Regina Vides; Tomlinson, M. Michele; Hargraves, Ryan Pamela; Bickman, Leonard

    2015-01-01

    Objective This study explored how clinician-reported content addressed in treatment sessions was predicted by clinician feedback group and multi-informant cumulative problem alerts that appeared in computerized feedback reports for 299 clients aged 11 to 18 years receiving home-based community mental health treatment. Method Measures included a clinician-report of content addressed in sessions and additional measures of treatment progress and process (e.g., therapeutic alliance) completed by clinicians, clients, and their caregivers. Item responses in the top 25th percentile in severity from these measures appeared as ‘problem alerts’ on corresponding computerized feedback reports. Clinicians randomized to the feedback group received feedback weekly while the control group did not. Analyses were conducted using the Cox proportional hazards regression for recurrent events. Results For all content domains, the results of the survival analyses indicated a robust effect of the feedback group on addressing specific content in sessions, with feedback associated with shorter duration to first occurrence and increased likelihood of addressing or focusing on a topic compared to the non-feedback group. Conclusion There appears to be an important relationship between feedback and cumulative problem alerts reported by multiple informants as they influence session content. PMID:26337327

  11. In vivo NMR microscopy allows short-term serial assessment of multiple skeletal implications of corticosteroid exposure

    PubMed Central

    Takahashi, Masaya; Wehrli, Felix W.; Hilaire, Luna; Zemel, Babette S.; Hwang, Scott N.

    2002-01-01

    Corticosteroids are in widespread clinical use but are known to have adverse skeletal side effects. Moreover, it is not known how soon these effects become apparent. Here, we describe a longitudinal approach to evaluate the short-term implications of excess corticosteroid exposure by quantitative in vivo magnetic resonance imaging and spectroscopy in conjunction with digital image processing and analysis in a rabbit model. Two-week treatment with dexamethasone induced a significant reduction in trabecular bone volume, which occurred at the expense of uniform trabecular thinning without affecting network architecture. Paralleling the loss in bone volume was conversion of hematopoietic to yellow marrow in the femoral metaphysis and atrophy of the femoral epiphyseal growth plate. This work demonstrates that detailed quantitative morphometric and physiological information can be obtained noninvasively at multiple skeletal locations. The method is likely to eventually replace invasive histomorphometry in that it obviates the need to sacrifice groups of animals at multiple time points. Finally, this work, which was performed on a clinical scanner, has implications for evaluating patients on high-dose steroid treatment. PMID:11904367

  12. The Impact of Drug Use in Social Networks of Patients with Substance Use and Bipolar Disorders

    PubMed Central

    McDonald, Leah J.; Griffin, Margaret L.; Kolodziej, Monika E.; Fitzmaurice, Garrett M.; Weiss, Roger D.

    2011-01-01

    In this exploratory analysis, we assessed the effect of drug use among social network members on recovery from drug dependence in patients with co-occurring bipolar disorder. Patients (n=57) enrolled in a group therapy study completed assessments over 15 months. Patients with 0–1 drug users in their social networks at intake had few days of drug use during treatment and follow-up, whereas those with ≥ 2 drug users had significantly more days of drug use. Multivariate analysis showed that patients who consistently named multiple drug users in their social networks had a marked increase in drug use over 15 months, while those who never or occasionally named multiple drug users had a small decline in drug use over time. Multiple drug users in social networks of treatment-seeking drug dependent patients with co-occurring bipolar disorder may indicate poor drug use outcomes; efforts to reduce the association with drug users may be useful. This clinical trial has been registered in a public trials registry at clinicaltrials.gov (identifier is NCT00227838). PMID:21314751

  13. A comparison of simulation-based education versus lecture-based instruction for toxicology training in emergency medicine residents.

    PubMed

    Maddry, Joseph K; Varney, Shawn M; Sessions, Daniel; Heard, Kennon; Thaxton, Robert E; Ganem, Victoria J; Zarzabal, Lee A; Bebarta, Vikhyat S

    2014-12-01

    Simulation-based teaching (SIM) is a common method for medical education. SIM exposes residents to uncommon scenarios that require critical, timely actions. SIM may be a valuable training method for critically ill poisoned patients whose diagnosis and treatment depend on key clinical findings. Our objective was to compare medical simulation (SIM) to traditional lecture-based instruction (LEC) for training emergency medicine (EM) residents in the acute management of critically ill poisoned patients. EM residents completed two pre-intervention questionnaires: (1) a 24-item multiple-choice test of four toxicological emergencies and (2) a questionnaire using a five-point Likert scale to rate the residents' comfort level in diagnosing and treating patients with specific toxicological emergencies. After completing the pre-intervention questionnaires, residents were randomized to SIM or LEC instruction. Two toxicologists and three EM physicians presented four toxicology topics to both groups in four 20-min sessions. One group was in the simulation center, and the other in a lecture hall. Each group then repeated the multiple-choice test and questionnaire immediately after instruction and again at 3 months after training. Answers were not discussed. The primary outcome was comparison of immediate mean post-intervention test scores and final scores 3 months later between SIM and LEC groups. Test score outcomes between groups were compared at each time point (pre-test, post-instruction, 3-month follow-up) using Wilcoxon rank sum test. Data were summarized by descriptive statistics. Continuous variables were characterized by means (SD) and tested using t tests or Wilcoxon rank sum. Categorical variables were summarized by frequencies (%) and compared between training groups with chi-square or Fisher's exact test. Thirty-two EM residents completed pre- and post-intervention tests and comfort questionnaires on the study day. Both groups had higher post-intervention mean test scores (p < 0.001), but the LEC group showed a greater improvement compared to the SIM group (5.6 [2.3] points vs. 3.6 [2.4], p = 0.02). At the 3-month follow-up, 24 (75 %) tests and questionnaires were completed. There was no improvement in 3-month mean test scores in either group compared to immediate post-test scores. The SIM group had higher final mean test scores than the LEC group (16.6 [3.1] vs. 13.3 [2.2], p = 0.009). SIM and LEC groups reported similar diagnosis and treatment comfort level scores at baseline and improved equally after instruction. At 3 months, there was no difference between groups in comfort level scores for diagnosis or treatment. Lecture-based teaching was more effective than simulation-based instruction immediately after intervention. At 3 months, the SIM group showed greater retention than the LEC group. Resident comfort levels for diagnosis and treatment were similar regardless of the type of education.

  14. Symbolic online exposure for spider fear: habituation of fear, disgust and physiological arousal and predictors of symptom improvement.

    PubMed

    Matthews, Allison; Naran, Nishma; Kirkby, Kenneth C

    2015-06-01

    This research compared the effects of real versus hyper-real images on anxiety, disgust, and physiological arousal during internet-delivered exposure in high spider-fearfuls. Hyper-real images were digitally altered to highlight fearful aspects. A further aim was to examine self-reported and behavioural therapeutic outcomes and exposure-related predictors of these outcomes. Twenty-eight females were randomised to real (n = 14) or hyper-real (n = 14) treatment groups and nine participants were subsequently allocated to a wait-list control group. Treatment groups viewed an 8-stage exposure hierarchy of real or hyper-real spider images. Subjective anxiety and disgust ratings were taken during each stage (0, 60, 120, 180 s) with heart rate and skin conductance recorded throughout. Anxiety, disgust and physiological arousal habituated within each exposure stage, with no differential effect of real compared to hyper-real images. Both treatment groups but not controls demonstrated significant reductions in behavioural avoidance and self-reported phobic symptoms from pre-treatment to post-treatment with large effect sizes noted. The change in within-stage habituation of anxiety, disgust and heart rate, between the first and last stage, predicted improvement in behavioural avoidance at post-treatment. This suggests that generalisation of habituation to multiple images is an important predictor of improvement. While findings in relation to therapeutic outcome should be considered preliminary, clear relationships were found between exposure-related variables and outcome among those who undertook treatment. Findings provide evidence in support of the efficacy of online image-based exposure and have implications for informing further research into the underlying mechanisms of image-based exposure treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Long-term treatment with low dose naltrexone maintains stable health in patients with multiple sclerosis.

    PubMed

    Ludwig, Michael D; Turel, Anthony P; Zagon, Ian S; McLaughlin, Patricia J

    2016-01-01

    A retrospective study was conducted on patients at Penn State Hershey Medical Center diagnosed with relapsing-remitting multiple sclerosis between 2006 and 2015. Laboratory and clinical data collected over this 10-year period were reviewed. Two cohorts of patients were established based on their relapsing-remitting multiple sclerosis therapy at the time of their first visit to Penn State. One group of patients ( n  = 23) was initially prescribed low dose naltrexone at the time first seen at Hershey. This group was offered low dose naltrexone because of symptoms of fatigue or refusal to take an available disease-modifying therapy. The second group of patients ( n  = 31) was treated with the glatiramer acetate (Copaxone) and offered low dose naltrexone as an adjunct therapy to their disease-modifying therapy. Patient data from visits after 1-50 months post-diagnosis were evaluated in a retrospective manner. Data obtained from patient charts included clinical laboratory values from standard blood tests, timed 25-foot walking trials, and changes in magnetic resonance imaging reports. Statistical analyses between the groups and for each patient over time indicated no significant differences in clinical laboratory values, timed walking, or changes in magnetic resonance imaging. These data suggest that the apparently non-toxic, inexpensive, biotherapeutic is safe and if taken alone did not result in an exacerbation of disease symptoms.

  16. Detection of multiple drug-resistant Trypanosoma congolense populations in village cattle of south-east Mali

    PubMed Central

    2012-01-01

    Background Tsetse fly-transmitted African animal trypanosomosis causes annual losses that run into billions of dollars. The disease is assumed to cause hunger and poverty in most sub-Saharan countries since it represents a serious impediment to sustainable livestock production. Both a cross-sectional and a longitudinal study were carried out from November to December 2007 to evaluate trypanosomosis risk and susceptibility of trypanosomes to trypanocidal drug treatment in village cattle populations in south-east Mali. Methods Eight purposively selected villages participated in the study. In each village, eight traps deployed along drainage lines over 24hour duration were used to catch tsetse. One hundred systematically selected cattle in the study villages were examined for trypanosomes. All trypanosome-positive cattle were randomly allocated into two treatment groups: a group treated with 0.5 mg/kg bw. isometamidium chloride (ISMM) and a group treated with 3.5 mg/kg bw. diminazene aceturate (DIM). The cattle were monitored for trypanosomes at day 14 and 28 post-treatment. Results Of the 796 cattle examined, 125 (15.7%) were trypanosome-positive. Village trypanosome prevalences ranged between 11% and 19%. There were no significant (p > 0.05) differences in the village trypanosome prevalences. Trypanosoma congolense was the dominant trypanosome species accounting for 73% (91/125) of the infections and T. vivax the remainder. Twenty (31.7%) of the 63 cattle on 0.5 mg/kg bw. ISMM treatment were still positive14 days post-treatment. Of the 43 aparasitaemic cattle monitored to day 28, 25.6% (11) became parasitaemic, resulting in a cumulative failure rate of 49.2% (31/63). Trypanosoma congolense accounted for 77.4% (24/31) of failed ISMM treatments. The 62 cattle treated with 3.5 mg/kg bw. DIM resulted in 30.6% (19/62) failed treatments. Although 42.2% (19/45) of T. congolense positive cattle did not respond to DIM treatment, all T. vivax positive cattle responded positively to DIM treatment. Conclusions The overreliance on trypanocides in the control of trypanosomosis will ultimately lead to multiple drug-resistant trypanosome populations as detected in villages in south-east Mali rendering the use of drugs doubtful. Effective alternative methods for trypanosomosis control ought to substitute chemotherapy to ensure sustainable cattle production in these villages. Since there is no single strategy for containing trypanocidal drug resistance, promotion of an integrated approach combining proven trypanosomosis control approaches in high trypanosomosis risk areas is most desirous. The best-bet strategy this study recommended for areas with multiple drug resistance included area-wide community tsetse control, control of co-infections to exploit self-cure against resistant trypanosome populations and the rational use of trypanocidal drugs which should be urgently promoted at all levels as a way of containing or reversing resistance. PMID:22852796

  17. Parent inclusion in Early Intensive Behavioral Intervention: the influence of parental stress, parent treatment fidelity and parent-mediated generalization of behavior targets on child outcomes.

    PubMed

    Strauss, Kristin; Vicari, Stefano; Valeri, Giovanni; D'Elia, Lidia; Arima, Serena; Fava, Leonardo

    2012-01-01

    Although early intensive behavior interventions have been efficient in producing positive behavior outcome in young children with Autism Spectrum Disorder, there is a considerable variety in the children's progress. Research has suggested that parental and treatment factors are likely to affect children's response to treatment. The purpose of the current study was to examine the interrelating factors that impact children's progress, highlighting the influence of parent inclusion in treatment provision captured by parental stress, how faithfully the parents followed the treatment protocols and the intensity of treatment provided at home. Twenty-four children received cross-setting staff- and parent-mediated EIBI, including continuous parent training and supervision. A comparison group of 20 children received eclectic intervention. Standardized tests were carried out by independent examiners at intake and after six months. The intervention group outperformed the eclectic group in measures of autism severity, developmental and language skills. Parent training and constant parent-mediated treatment provision led to reduced challenging behaviors from the children, increased treatment fidelity and child direct behavior change as measured by performance in correct responding on behavior targets. Variables of treatment progress and potential predictors of child outcome were analyzed in detail and mapped with regard to their relationships drawn from multiple regression analysis. Particularly, the study highlights an association between parental stress and staff treatment fidelity that interferes with decision making in treatment planning and consequently with positive behavior outcome. Such results provide important scientific and clinical information on parental and treatment factors likely to affect a child's response to treatment. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. A Multiple-Sequence Variant of the Multiple-Baseline Design: A Strategy for Analysis of Sequence Effects and Treatment Comparison.

    ERIC Educational Resources Information Center

    Noell, George H.; Gresham, Frank M.

    2001-01-01

    Describes design logic and potential uses of a variant of the multiple-baseline design. The multiple-baseline multiple-sequence (MBL-MS) consists of multiple-baseline designs that are interlaced with one another and include all possible sequences of treatments. The MBL-MS design appears to be primarily useful for comparison of treatments taking…

  19. Equilibrium Performance Changes Produced by Atropine in M. mulatta and M. fascicularis.

    DTIC Science & Technology

    1981-09-01

    the behavior of one animal within each group was more severely disrupted than the others. A Student -Newman-Keuls Multiple Comparison Test (31) on the...Med 45(11):1291- 1297 (1974). 7. I)ix, M. R. Treatment of vertigo. Physiotherapy 60(12):380-384 (1974). 8. Fregly, A. R., M. J. Smith, C. D. Wood, and

  20. Therapeutic Guidance for Infants and Families: Using Multi-Family Groups as an Extension of Child-Parent Psychotherapy

    ERIC Educational Resources Information Center

    Frame, Laura; Ivins, Barbara; Wong, Lynette; Cantrell, Sally

    2015-01-01

    Treatment of very young children in foster care involves the complex dynamics of a child's trauma history, multiple relationships, and caregivers' and providers' feelings about working with the child welfare system. Through the story of a toddler removed from his parents and placed in foster care, the authors illustrate a model of combined group…

  1. Helping Children Exposed to War and Violence: Perspectives from an International Work Group on Interventions for Youth and Families

    ERIC Educational Resources Information Center

    Kletter, Hilit; Rialon, Rebecca A.; Laor, Nathaniel; Brom, Daniel; Pat-Horenczyk, Ruth; Shaheen, Mohammed; Hamiel, Daniel; Chemtob, Claude; Weems, Carl F.; Feinstein, Carl; Lieberman, Alicia; Reicherter, Daryn; Song, Suzan; Carrion, Victor G.

    2013-01-01

    Background: This paper outlines conclusions from a three-day workgroup hosting the eight authors as well as others with expertise in the evaluation and treatment of youth exposed to war and violence. Objective: The purpose of this meeting was to bring multiple perspectives together to identify components that comprise effective psychosocial…

  2. THE EFFECTS ON LEARNING FROM A MOTION PICTURE FILM OF SELECTIVE CHANGES IN SOUND TRACK LOUDNESS LEVEL. FINAL REPORT.

    ERIC Educational Resources Information Center

    MOAKLEY, FRANCIS X.

    EFFECTS OF PERIODIC VARIATIONS IN AN INSTRUCTIONAL FILM'S NORMAL LOUDNESS LEVEL FOR RELEVANT AND IRRELEVANT FILM SEQUENCES WERE MEASURED BY A MULTIPLE CHOICE TEST. RIGOROUS PILOT STUDIES, RANDOM GROUPING OF SEVENTH GRADERS FOR TREATMENTS, AND RATINGS OF RELEVANT AND IRRELEVANT PORTIONS OF THE FILM BY AN UNSPECIFIED NUMBER OF JUDGES PRECEDED THE…

  3. [Correlation of Th17 Cells and IL-17 Level in Multiple Myeloma Patients with Pathogenesis of Multiple Myeloma].

    PubMed

    DU, Chao-Yang; Yang, Ru-Yu; Li, Chao; Duan, Li-Juan

    2017-02-01

    To explore the correlation of Th17 cell rate and IL-17 level with pathogenetis of multiple myeloma(MM). Forty-five cases of MM were enrolled in MM group, while 45 healthy volunteers were selected in control group. The rate of Th17 cells, levels of IL-17 and β2-microglobulin(β2-MG) in patients subgrouping according to ISS staging and treatment were detected by using flow cytometer and IL-17 assay kit. The correlation of Th17 cell rate and IL-17 level with MM was analyzed. The rate of Th17 cells and level of IL-17 in MM group were higher than those in control group(P<0.05), the rate of Th17 cells and level of IL-17 in ISS III stage patients were higher than those in ISS I and II stage patients(P<0.05); the rate of Th17 cells and level of IL-17 in ISS I and ISS II stage patients were not significant difference (P>0.05); the rate of Th17 cells and level of IL-17 in firstly treated, retreated/refractory patients were significantly higher than those in patients with effective treatment(P<0.05), while the rate of Th17 cells and level of IL-17 between firstly treated patients and retreated/refractory patients were not significant difference (P>0.05). The Th17 rate and IL-17 level in MM patients positively correlated with β2-MG level (r=0.422, r=0.416, P<0.05). The obvious increase of Th17 rate, IL-17 and β2-MG levels closely relates with pathogenesis of MM. The Th17 rate and IL-17 level may be used as important evidence for evaluation of ISS stage and therapeutic efficacy of MM.

  4. Healthcare resource utilization among patients with relapsed multiple myeloma in the UK, France, and Italy.

    PubMed

    Gonzalez-McQuire, Sebastian; Yong, Kwee; Leleu, Henri; Mennini, Francesco S; Flinois, Alain; Gazzola, Carlotta; Schoen, Paul; Campioni, Marco; DeCosta, Lucy; Fink, Leah

    2018-05-01

    To assess the real-world healthcare resource utilization (HRU) and costs associated with different treatment regimens used in the management of patients with relapsed multiple myeloma in the UK, France, and Italy. Retrospective medical chart review of characteristics, time to progression, level of response, HRU during treatment, and adverse events (AEs). Data collection started on June 1, 2015 and was completed on July 15, 2015. In the 3 months before record abstraction, eligible patients had either disease progression after receiving one of their country's most commonly prescribed regimens or had received the best supportive care and died. Costs were calculated based on HRU and country-specific diagnosis-related group and/or unit reference costs, amongst other standard resources. Physicians provided data for 1,282 patients (387 in the UK, 502 in France, 393 in Italy) who met the inclusion criteria. Mean [median] total healthcare costs associated with a single line of treatment were €51,717 [35,951] in the UK, €37,009 [32,538] for France, and €34,496 [42,342] for Italy, driven largely by anti-myeloma medications costs (contributing 95.0%, 90.0%, and 94.2% of total cost, respectively). During active treatment, the highest costs were associated with lenalidomide- and pomalidomide-based regimens. Mean cost per month was lowest for patients achieving a very good partial response or better. Unscheduled events (i.e. not considered part of routine management, whether or not related to multiple myeloma, such as unscheduled hospitalization, AEs, fractures) accounted for 1-9% of total costs and were highest for bendamustine. The use of retrospective data means that clinical practice (e.g. use of medical procedures, evaluation of treatment response) is not standardized across participating countries/centers, and some data (e.g. low-grade AEs) may be incomplete or differently adjudicated/reported. The centers involved may not be fully representative of national practice. Drug costs are the main contributor to total HRU costs associated with multiple myeloma. The duration of active treatment may influence the average total costs, as well as response, associated with a single line of therapy. Improved treatment outcomes, and reductions in unscheduled events and concomitant medication use may, therefore, reduce the overall HRU and related costs of care in multiple myeloma.

  5. Cost-Effectiveness Analysis of Initial Treatment Strategies for Nonembolic Acute Limb Ischemia Using Real-Word Data.

    PubMed

    Vaidya, Varun; Gangan, Nilesh; Comerota, Anthony; Lurie, Fedor

    2017-02-01

    Nonembolic acute limb ischemia (ALI) is a condition characterized by a sudden decrease in limb perfusion and requires immediate interventions. There are multiple treatment options available including surgery, catheter-directed thrombolysis (CDT), endovascular procedures, and hybrid treatment (a combination of open and endovascular techniques). Randomized trials provide information only on clinical efficacy, but not on economic outcomes. The objective of the study was to perform the cost-effective analysis comparing different treatment alternatives of ALI. The data were collected from 4r ProMedica community hospitals in the Northwest Ohio from January 2009 to December 2012. Patients were included if they were treated within 14 days of onset of symptoms for nonembolic ALI and were divided into groups of receiving CDT, surgery, endovascular, or hybrid treatments. Demographics, comorbidities, medications taken before admission, and smoking status were collected at baseline for all patients and were compared among the treatment groups. A cost-effectiveness decision tree was developed to calculate expected costs and life years gained associated with available treatment options. A probabilistic sensitivity analysis was also performed to check the robustness of the model. A population of 205 patients with the diagnosis of ALI was included and divided into different treatment groups. There was no major significant difference in baseline characteristics among the studied groups (P > 0.05). The total costs were $17,163.47 for surgery, $20,620.39 for endovascular, $21,277.61 for hybrid, and $30,675.42 for CDT. The life years gained were 17.25 for surgery, 18 for endovascular, 18 for hybrid, and 17 for CDT. CDT was dominated because of the high cost and the low effectiveness, while hybrid treatment was dominated when compared with endovascular treatment because these 2 treatments have similar outcomes. The incremental cost-effectiveness ratio of the endovascular group over the surgery group was found to be $4,609.23 per life year gained. The sensitivity analysis showed that the endovascular treatment was found to be cost-effective under willingness to pay $50,000. This study provides economic evaluation of ALI treatments for a defined clinical population in the real-world setting. Compared with other available alternatives, the endovascular treatment showed to be a cost-effective use of healthcare resources. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Posttraumatic headache: biopsychosocial comparisons with multiple control groups.

    PubMed

    Tatrow, Kristin; Blanchard, Edward B; Hickling, Edward J; Silverman, Daniel J

    2003-01-01

    This study examined somatic, psychological, and cognitive functioning of subjects with posttraumatic headache in comparison with multiple control groups. Posttraumatic headache is not as widely studied as other forms of headache (eg, tension-type, migraine). Previous research has suggested poor psychological functioning in patients with posttraumatic headache in comparison with other groups of patients with pain; however, this group has yet to be compared with a group of persons who have experienced trauma but are headache-free. Nineteen subjects with posttraumatic headache were studied, with full assessments available for 14 participants. Comparison groups, containing 16 participants each, included another headache group, a nonheadache group, and a trauma (motor vehicle accident) survivor nonheadache group. Participants completed several measures assessing somatic, psychological, and cognitive functioning. Findings revealed that the posttraumatic headache group exhibited significantly poorer functioning than the comparison groups on several measures including the Psychosomatic Symptom Checklist, Postconcussion Syndrome Checklist, axis II psychiatric diagnoses, Minnesota Multiphasic Personality Inventory, and the Daily Hassles Scale (frequency and total). Additionally, they scored higher on the following: number of axis I psychiatric diagnoses, the Daily Hassles Scale (intensity), Beck Depression Inventory, State-Trait Anxiety Inventory, and State-Trait Anger Expression Inventory. The posttraumatic headache group was similar to the other trauma group on the Posttraumatic Stress Disorder Symptom Checklist and the Life-Trauma Checklist. This study confirmed the distress seen in this understudied population of persons with headache and highlights areas of focus for proper assessment and treatment of those with headache and who have had an accident.

  7. Somatic symptoms: an important index in predicting the outcome of depression at six-month and two-year follow-up points among outpatients with major depressive disorder.

    PubMed

    Hung, Ching-I; Liu, Chia-Yih; Wang, Shuu-Jiun; Juang, Yeong-Yuh; Yang, Ching-Hui

    2010-09-01

    Few studies have simultaneously compared the ability of depression, anxiety, and somatic symptoms to predict the outcome of major depressive disorder (MDD). This study aimed to compare the MDD outcome predictive ability of depression, anxiety, and somatic severity at 6-month and 2-year follow-ups. One-hundred and thirty-five outpatients (men/women=34/101) with MDD were enrolled. Depression and anxiety were evaluated by the Hamilton Depression Rating Scale, Hospital Anxiety and Depression Scale, and depression subscale of the Depression and Somatic Symptoms Scale (DSSS). Somatic severity was evaluated by the somatic subscale of the DSSS. Subjects undergoing pharmacotherapy in the follow-up month were categorized into the treatment group; the others were categorized into the no-treatment group. Multiple linear regressions were used to identify the scales most powerful in predicting MDD outcome. Among the 135 subjects, 119 and 106 completed the 6-month and 2-year follow-ups, respectively. Somatic severity at baseline was correlated with the outcomes of the three scales at the two follow-ups. After controlling for demographic variables, somatic severity independently predicted most outcomes of the three scales at the two follow-ups in the no-treatment group and the cost of pharmacotherapy and DSSS score at the 6-month follow-up in the treatment group. Division of the subjects into treatment and no-treatment groups was not based on randomization and bias might have been introduced. Somatic severity was the most powerful index in predicting MDD outcome. Psychometric scales with appropriate somatic symptom items may be more accurate in predicting MDD outcome. 2010 Elsevier B.V. All rights reserved.

  8. Neurofilament light antibodies in serum reflect response to natalizumab treatment in multiple sclerosis.

    PubMed

    Amor, Sandra; van der Star, Baukje J; Bosca, Isabel; Raffel, Joel; Gnanapavan, Sharmilee; Watchorn, Jonathan; Kuhle, Jens; Giovannoni, Gavin; Baker, David; Malaspina, Andrea; Puentes, Fabiola

    2014-09-01

    Increased levels of antibodies to neurofilament light protein (NF-L) in biological fluids have been found to reflect neuroinflammatory responses and neurodegeneration in multiple sclerosis (MS). To evaluate whether levels of serum antibodies against NF-L correlate with clinical variants and treatment response in MS. The autoantibody reactivity to NF-L protein was tested in serum samples from patients with relapsing-remitting MS (RRMS) (n=22) and secondary progressive MS (SPMS) (n=26). Two other cohorts of RRMS patients under treatment with natalizumab were analysed cross-sectionally (n=16) and longitudinally (n=24). The follow-up samples were taken at 6, 12, 18 and 24 months after treatment, and the NF-L antibody levels were compared against baseline levels. NF-L antibodies were higher in MS clinical groups than healthy controls and in RRMS compared to SPMS patients (p<0.001). NF-L antibody levels were lower in natalizumab treated than in untreated patients (p<0.001). In the longitudinal series, NF-L antibody levels decreased over time and a significant difference was found following 24 months of treatment compared with baseline measurements (p=0.001). Drug efficacy in MS treatment indicates the potential use of monitoring the content of antibodies against the NF-L chain as a predictive biomarker of treatment response in MS. © The Author(s) 2014.

  9. MO-D-BRC-04: Multiple-Criteria Optimization Planning

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Donaghue, J.

    Treatment planning is a central part of radiation therapy, including delineation in tumor volumes and critical organs, setting treatment goals of prescription doses to the tumor targets and tolerance doses to the critical organs, and finally generation of treatment plans to meet the treatment goals. National groups like RTOG have led the effort to standardize treatment goals of the prescription doses to the tumor targets and tolerance doses to the critical organs based on accumulated knowledge from decades of abundant clinical trial experience. The challenge for each clinical department is how to achieve or surpass these set goals within themore » time constraints of clinical practice. Using fifteen testing cases from different treatment sites such as head and neck, prostate with and without pelvic lymph nodes, SBRT spine, we will present clinically utility of advanced planning tools, including knowledge based, automatic based, and multiple criteria based tools that are clinically implemented. The objectives of this session are: Understand differences among these three advanced planning tools Provide clinical assessments on the utility of the advanced planning tools Discuss clinical challenges of treatment planning with large variations in tumor volumes and their relationships with adjacent critical organs. Ping Xia received research grant from Philips. Jackie Wu received research grant from Varian; P. Xia, Research support by Philips and Varian; Q. Wu, NIH, Varian Medical.« less

  10. Monetary reward processing in obese individuals with and without binge eating disorder.

    PubMed

    Balodis, Iris M; Kober, Hedy; Worhunsky, Patrick D; White, Marney A; Stevens, Michael C; Pearlson, Godfrey D; Sinha, Rajita; Grilo, Carlos M; Potenza, Marc N

    2013-05-01

    An important step in obesity research involves identifying neurobiological underpinnings of nonfood reward processing unique to specific subgroups of obese individuals. Nineteen obese individuals seeking treatment for binge eating disorder (BED) were compared with 19 non-BED obese individuals (OB) and 19 lean control subjects (LC) while performing a monetary reward/loss task that parses anticipatory and outcome components during functional magnetic resonance imaging. Differences in regional activation were investigated in BED, OB, and LC groups during reward/loss prospect, anticipation, and notification. Relative to the LC group, the OB group demonstrated increased ventral striatal and ventromedial prefrontal cortex activity during anticipatory phases. In contrast, the BED group relative to the OB group demonstrated diminished bilateral ventral striatal activity during anticipatory reward/loss processing. No differences were observed between the BED and LC groups in the ventral striatum. Heterogeneity exists among obese individuals with respect to the neural correlates of reward/loss processing. Neural differences in separable groups with obesity suggest that multiple, varying interventions might be important in optimizing prevention and treatment strategies for obesity. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  11. Safety of fluralaner chewable tablets (BravectoTM), a novel systemic antiparasitic drug, in dogs after oral administration

    PubMed Central

    2014-01-01

    Background Fluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment. This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose. Methods Thirty-two (16 male and 16 female) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study. Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56, 168, and 280 mg fluralaner/kg body weight, equivalent to 1, 3, and 5 times the highest recommended treatment dose of fluralaner; sham dosed dogs served as controls. During the study, all dogs were clinically observed, and their health was carefully monitored including body weight development, food consumption and measurement of hematology, coagulation, clinical chemistry (including measurement of levels of ACTH and C-reactive protein) and urinalysis. Following euthanasia of the dogs, complete gross post mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted. Results There were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights; none of these findings were considered to be of clinical relevance. Conclusions Oral administration of fluralaner at the highest recommended treatment dose (56 mg/kg) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg. PMID:24606886

  12. Current challenges and possible solutions to improve access to care and treatment for hepatitis C infection in Vietnam: a systematic review.

    PubMed

    Berto, Alessandra; Day, Jeremy; Van Vinh Chau, Nguyen; Thwaites, Guy E; My, Ngoc Nghiem; Baker, Stephen; Darton, Thomas C

    2017-04-11

    Hepatitis C infection is a major public health concern in low- and middle-income countries where an estimated 71.1 million individuals are living with chronic infection. The World Health Organization (WHO) has recently released new guidance for hepatitis C virus (HCV) treatment programs, which include improving the access to new direct-acting antiviral agents. In Vietnam, a highly populated middle-income country, the seroprevalence of HCV infection is approximately 4% and multiple genotypes co-circulate in the general population. Here we review what is currently known regarding the epidemiology of HCV in Vietnam and outline options for reducing the significant burden of morbidity and mortality in our setting. We performed a systematic review of the currently available literature to evaluate what has been achieved to date with efforts to control HCV infection in Vietnam. This search retrieved few publications specific to Vietnam indicating a significant gap in baseline epidemiological and public health data. Key knowledge gaps identified included an understanding of the prevalence in specific high-risk groups, characterization of circulating HCV genotypes in the population and likely response to treatment, and the extent to which HCV treatment is available, accessed and utilized. We conclude that there is an urgent need to perform up to date assessments of HCV disease burden in Vietnam, especially in high-risk groups, in whom incidence is high and cross infection with multiple genotypes is likely to be frequent. Coordinating renewed surveillance measures with forthcoming HCV treatment studies should initiate the traction required to achieve the WHO goal of eliminating HCV as a public health threat by 2030, at least in this region.

  13. What influences participation in genetic carrier testing? Results from a discrete choice experiment.

    PubMed

    Hall, Jane; Fiebig, Denzil G; King, Madeleine T; Hossain, Ishrat; Louviere, Jordan J

    2006-05-01

    This study explores factors that influence participation in genetic testing programs and the acceptance of multiple tests. Tay Sachs and cystic fibrosis are both genetically determined recessive disorders with differing severity, treatment availability, and prevalence in different population groups. We used a discrete choice experiment with a general community and an Ashkenazi Jewish sample; data were analysed using multinomial logit with random coefficients. Although Jewish respondents were more likely to be tested, both groups seem to be making very similar tradeoffs across attributes when they make genetic testing choices.

  14. Individualized treatment in stage IVC nasopharyngeal carcinoma.

    PubMed

    Chan, Oscar S H; Ngan, Roger K C

    2014-09-01

    The stage IVC nasopharyngeal carcinoma is a catch-all entity covering minute solitary metastasis to bulky disseminated disease. Prognosis varies greatly within this stage group. A subset of patients with oligometastases may benefit from aggressive local ablative therapy. Meanwhile, in multiple metastatic diseases, customizing conventional cytotoxics basing on individual tumor characteristics and previous chemotherapy responses can be a new direction to improve therapeutic results. Prognostic models built on clinical features and genomic profiles can be utilized to stratify different risk groups and tailor therapy schemes. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Impact of educational intervention on willingness-to-pay for health insurance: A study of informal sector workers in urban Bangladesh.

    PubMed

    Khan, Jahangir Am; Ahmed, Sayem

    2013-04-29

    The reliance on out-of-pocket payments for health services leads to a catastrophic burden for many households in Bangladesh. The World Health Organization suggests that risk-pooling mechanisms should be used for financing healthcare. Like many low-income countries (LIC), a large share of employment in Bangladesh is in the informal sector (88%). Inclusion of these workers in health insurance is a big challenge. Among other barriers, the "literacy gap" for health insurance" is a reason for the low insurance uptake in Bangladesh. The aim of this study is, therefore, to assess the impact of an educational intervention on willingness-to-pay (WTP) for health insurance among informal sector workers in urban Bangladesh. An educational intervention on occupational solidarity and health insurance is offered to groups of informal workers. Educational sessions take place once a week (3-4 hours) during three subsequent weeks for each occupational group. For assessing the impact of the educational intervention, WTP for joining health insurance using occupational solidarity between workers in "pre- and post-treatment" periods as well as between "control and treatment" groups were compared. Multiple-regression analysis is applied for predicting WTP by educational intervention, while controlling for demographic and socioeconomic characteristics. The coefficient of variation (CoV) of the WTP is estimated in control and treatment groups and expected to be lower in the latter. The WTP for health insurance is higher (33.8%) among workers who joined the educational intervention in comparison with those who did not (control group). CoV of WTP is found to be generally lower in post-treatment period and in treatment group compared to pre-treatment period and control group respectively. Educational interventions can be used for increasing demand for health insurance scheme using occupational solidarity among informal sector workers.

  16. A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis.

    PubMed

    Iannitti, Tommaso; Palmieri, Beniamino; Aspiro, Anna; Di Cerbo, Alessandro

    2014-01-01

    Hyperhidrosis is a chronic disease characterized by increased sweat production. Local injections of botulinum toxin A (BTX-A) have been extensively used for treatment of primary hyperhidrosis (idiopathic). The current treatment for this condition involves several intradermal injections, resulting in poor patient compliance due to injection-related pain. Therefore, new protocols, including an improved anesthetic regimen, are required. We designed the present study to determine whether JetPeel™-3, a medical device used for transdermal delivery of drugs by jet nebulization, could be used to deliver lidocaine prior to the standard multiple BTX-A injections or deliver lidocaine together with BTX-A in order to determine the protocol giving better results in terms of procedure-related pain, sweating, and patient satisfaction in subjects affected by primary axillary, palmar or plantar hyperhidrosis. Twenty patients with a visual analog scale (VAS) sweating score ≥ 8 cm were randomized to receive lidocaine 2% (5 mL) delivered by JetPeel™-3 followed by multiple injections of BTX-A (100 units) or lidocaine 2% (5 mL) and BTX-A (50 units) delivered together by JetPeel™-3. Effect of treatment on sweating was measured by VAS (0= minimum sweating; 10= maximum sweating) at 3-month follow-up. Pain induced by the procedure was assessed by VAS (0= minimum pain; 10= maximum pain) immediately after the procedure. Patient satisfaction was assessed at 3-month follow-up using a 5-point scale (1= not at all satisfied; 2= not satisfied; 3= partially satisfied; 4= satisfied; 5= highly satisfied). Both treatment modalities reduced sweating at 3-month follow-up, if compared with baseline (all P<0.001). Delivery of lidocaine and BTX-A by JetPeel™-3 resulted in lower procedure-related pain and reduced sweating, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (all P<0.001). Patient satisfaction with the procedure was higher in the group receiving lidocaine and BTX-A treatment by JetPeel™-3, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (P<0.001). No side effects were observed in both groups. Lidocaine and BTX-A can be safely delivered together by JetPeel™-3 to treat primary palmar, plantar and axillary hyperhidrosis, resulting in lower procedure-related pain, improved sweating and higher patient satisfaction, if compared with lidocaine delivered by JetPeel™-3 followed by standard BTX-A injection therapy. Our protocol delivering lidocaine and BTX-A together by JetPeel™-3 requires a reduced quantity of BTX-A, further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis.

  17. The Effect of Sitagliptin on the Regression of Carotid Intima-Media Thickening in Patients with Type 2 Diabetes Mellitus: A Post Hoc Analysis of the Sitagliptin Preventive Study of Intima-Media Thickness Evaluation.

    PubMed

    Mita, Tomoya; Katakami, Naoto; Shiraiwa, Toshihiko; Yoshii, Hidenori; Gosho, Masahiko; Shimomura, Iichiro; Watada, Hirotaka

    2017-01-01

    Background. The effect of dipeptidyl peptidase-4 (DPP-4) inhibitors on the regression of carotid IMT remains largely unknown. The present study aimed to clarify whether sitagliptin, DPP-4 inhibitor, could regress carotid intima-media thickness (IMT) in insulin-treated patients with type 2 diabetes mellitus (T2DM). Methods . This is an exploratory analysis of a randomized trial in which we investigated the effect of sitagliptin on the progression of carotid IMT in insulin-treated patients with T2DM. Here, we compared the efficacy of sitagliptin treatment on the number of patients who showed regression of carotid IMT of ≥0.10 mm in a post hoc analysis. Results . The percentages of the number of the patients who showed regression of mean-IMT-CCA (28.9% in the sitagliptin group versus 16.4% in the conventional group, P  = 0.022) and left max-IMT-CCA (43.0% in the sitagliptin group versus 26.2% in the conventional group, P  = 0.007), but not right max-IMT-CCA, were higher in the sitagliptin treatment group compared with those in the non-DPP-4 inhibitor treatment group. In multiple logistic regression analysis, sitagliptin treatment significantly achieved higher target attainment of mean-IMT-CCA ≥0.10 mm and right and left max-IMT-CCA ≥0.10 mm compared to conventional treatment. Conclusions . Our data suggested that DPP-4 inhibitors were associated with the regression of carotid atherosclerosis in insulin-treated T2DM patients. This study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000007396).

  18. Evidence for the importance of personalized molecular profiling in pancreatic cancer.

    PubMed

    Lili, Loukia N; Matyunina, Lilya V; Walker, L DeEtte; Daneker, George W; McDonald, John F

    2014-03-01

    There is a growing body of evidence that targeted gene therapy holds great promise for the future treatment of cancer. A crucial step in this therapy is the accurate identification of appropriate candidate genes/pathways for targeted treatment. One approach is to identify variant genes/pathways that are significantly enriched in groups of afflicted individuals relative to control subjects. However, if there are multiple molecular pathways to the same cancer, the molecular determinants of the disease may be heterogeneous among individuals and possibly go undetected by group analyses. In an effort to explore this question in pancreatic cancer, we compared the most significantly differentially expressed genes/pathways between cancer and control patient samples as determined by group versus personalized analyses. We found little to no overlap between genes/pathways identified by gene expression profiling using group analyses relative to those identified by personalized analyses. Our results indicate that personalized and not group molecular profiling is the most appropriate approach for the identification of putative candidates for targeted gene therapy of pancreatic and perhaps other cancers with heterogeneous molecular etiology.

  19. Effect of surface treatments on the bond strength of soft denture lining materials to an acrylic resin denture base.

    PubMed

    Gundogdu, Mustafa; Yesil Duymus, Zeynep; Alkurt, Murat

    2014-10-01

    Adhesive failure between acrylic resin and resilient liner material is commonly encountered in clinical practice. The purpose of this study was to evaluate the effect of different surface treatments on the bond strength of 2 different resilient lining materials to an acrylic resin denture base. Ninety-six dumbbell-shaped specimens were fabricated from heat-polymerized acrylic resin, and 3 mm of the material was cut from the thin midsection. The specimens were divided into 6 groups according to their surface treatments: no surface treatment (control group), 36% phosphoric acid etching (acid group), erbium:yttrium-aluminum-garnet (Er:YAG) laser (laser group), airborne-particle abrasion with 50-μm Al2O3 particles (abrasion group), an acid+laser group, and an abrasion+laser group. The specimens in each group were divided into 2 subgroups according to the resilient lining material used: heat-polymerized silicone based resilient liner (Molloplast B) and autopolymerized silicone-based resilient liner (Ufi Gel P). After all of the specimens had been polymerized, they were stored in distilled water at 37°C for 1 week. A tensile bond strength test was then performed. Data were analyzed with a 2-way ANOVA, and the Sidak multiple comparison test was used to identify significant differences (α=.05). The effects of the surface treatments and resilient lining materials on the surface of the denture base resin were examined with scanning electron microscopy. The tensile bond strength was significantly different between Molloplast B and Ufi Gel P (P<.001). The specimens of the acid group had the highest tensile bond strength, whereas those of the abrasion group had the lowest tensile bond strength. The scanning electron microscopy observations showed that the application of surface treatments modified the surface of the denture base resin. Molloplast B exhibited significantly higher bond strength than Ufi Gel P. Altering the surface of the acrylic resin denture base with 36% phosphoric acid etching increased bond strength. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  20. Changes in LORETA and conventional patterns of P600 after steroid treatment in multiple sclerosis patients.

    PubMed

    Papageorgiou, Charalabos C; Sfagos, Costas; Kosma, Katerina K; Kontoangelos, Kostantinos A; Triantafyllou, Nikolaos; Vassilopoulos, Dimitrios; Rabavilas, Andreas D; Soldatos, Constantin R

    2007-01-30

    The P600 component of event-related potentials (ERPs) reflecting the 'rule-governed sequence of information processing', has been associated with multiple sclerosis (MS)-related cognition. The present study aimed at examining the effects of methylprednisolone treatment in MS patients on cognition as reflected by the low-resolution brain electromagnetic tomography (LORETA) of the P600 as well as its conventional constituents (amplitudes and latencies) recorded during a working memory (WM) test. A paired LORETA comparison was performed in the P600 component of ERPs elicited during a (WM) test in 18 MS patients suffering from the relapsing-remitting form, before and after 1 week treatment with methylprednisolone. The P600 component was also evaluated in 16 healthy controls matched to the patients on age and educational level. When pre- and post-treatment recordings of LORETA were compared all patients as a group showed significantly different patterns of current density activation located at right frontal lobe. The treatment was accompanied by an increase of the amplitude of P600 at the right frontoparietal area. In the post-treatment phase the patients exhibited significant improvement of the memory performance as compared to themselves before treatment. As a result both the P600 amplitudes and memory performance at post-treatment were closer to those exhibited by normal controls. These findings support the notion that steroid treatment in relapsing-remitting MS patients, may exert a beneficial effect in 'rule-governed sequence of information processing'.

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