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121. Sancuso - granisetron

. The quality of the starting material supplied by different manufacturers is satisfactory. The manufacturing processes are well established and reproducible and the specification of granisetron ensures that the product fully meets the requirements. Adequate details are provided for the quality control testing performed during the synthesis; these include specifications and the associated test methods for all the raw materials used in the process plus any in-process testing also with limits and test method (...) . These procedures and tests ensure that the processes are properly and adequately controlled. Batch analysis from production scale batches, are provided ensuring consistency in the manufacture of the active substance. Specification As the active substance in Sancuso preparation, presented in a form of granisetron base, is identical to the active moiety of the reference product Kytril 1 mg Tablet (granisetron hydrochloride), for the purposes of setting specifications the existing European Pharmacopoeia (Ph. Eur

2012 European Medicines Agency - EPARs

122. Perampanel (Fycompa)

. Doi notes that in the Phase 1 Study 013, the Romberg test was performed and showed a shift from normal to abnormal in a higher percentage of perampanel subjects vs placebo or moxifloxacin and Dr. Doi notes that this indicates a loss in proprioception (sensory) rather than a cerebellar cause for loss of coordination. Somnolence and Fatigue – In the epilepsy Phase 3 DB pool, subjects treated with perampanel experienced the TEAEs of somnolence, fatigue, asthenia, and lethargy (but not sedation

2012 FDA - Drug Approval Package

123. Parent Training Interventions for Attention Deficity Hyperactivity Disorder (ADHD) in Children Aged 5 to 18 years Full Text available with Trip Pro

The diagnosis of ADHD has stimulated considerable debate and sometimes strong and conflicting views (Jadad 1999b). Inattention, hyperactivity and impulsivity are normal traits in children, especially young children. There is no reliable test to confirm diagnostic validity, so diagnoses depend on clinical judgment. Consensus among experts in the field (Barkley 2002a) might exist but diagnoses may be open to bias. The use of operationalised diagnostic criteria, such as the DSM‐IV (APA 1994) or ICD‐10 (WHO (...) ; for example, Achenbach Child Behaviour Checklist ( ) All primary outcomes related to participant children, not to parent outcomes (for example, reduction of parental stress), so studies with only parent outcomes were excluded. See also Potential biases in the review process. 3.1.4.2 Secondary outcomes • * Academic achievement of children as measured through school test results or general tests of language or development • *Adverse events (these could include emotional or psychological trauma of any kind

2012 Campbell Collaboration

124. Behavioural and cognitive?behavioural group?based parenting programmes for early?onset conduct problems in children aged 3 to 12 years Full Text available with Trip Pro

of programme deliverers) is critical to programme success, a programme might be efficacious within experimental research settings but not effective when rolled out within more naturalistic settings ( ; ). There is increasing evidence that another important mechanism of change within behavioural and cognitive‐behavioural group‐based interventions may involve change in parenting skill as a substantial predictor of the child problem behaviour outcome ( ; ). On the other hand, qualitative studies highlight (...) if the means and standard deviations were available, or if we could calculate effect sizes from other data (for example, from t‐tests, F‐tests, or exact P values). We contacted study authors to provide missing data as necessary (see Appendix 3). Within the section on individual study data, we present continuous data using similar, but not identical, instruments as standardised mean differences (SMDs) and dichotomous data as risk ratios (RR). There were several different instruments measuring an outcome

2012 Campbell Collaboration

125. Indicated Truancy Interventions: Effects on School Attendance among Chronic Truant Students Full Text available with Trip Pro

or criteria. Second, this review will attempt to include evaluations of interventions operating in a broader set of geographical contexts than those of previous reviews. The search will be inclusive of interventions being conducted and tested in the United States as well as in other countries with similar educational systems, which will allow us to potentially identify studies that have been missed in prior reviews. Third, we will evaluate whether the research base is an adequate representation (...) of studies testing indicated (i.e., Tier 3) interventions with chronic truant students. 2 Objectives The main objective of this review was to examine the effects of indicated intervention programs on attendance outcomes of elementary and secondary school students who were identified as having chronic attendance problems. The specific questions guiding this study were: 1) Do indicated programs with a goal of increasing student attendance affect school attendance behaviors of elementary and secondary

2012 Campbell Collaboration

126. Cognitive?Behavioural Interventions for Children Who Have Been Sexually Abused: A Systematic Review Full Text available with Trip Pro

screening tools (post‐traumatic stress disorder and eating disorders). The authors report that “all were strongly and highly significantly associated with childhood sexual abuse (P = < 0.0001), particularly if non‐consensual sexual intercourse was involved, for which odds ratios (ORs) ranged from 3.7 to 12.1. For some disorders, the relative odds were higher for females than males, but formal tests for moderation by gender were significant only for common mental disorders and then only in relation (...) of being sexually abused, or related to the other difficulties that children in these situations often face. Some studies suggest that being brought up witnessing or experiencing intrafamilial violence may combine with the experience of sexual abuse to increase the risk of a young man subsequently abusing others ( ). Longer‐term prospective studies testing and examining these consequences are awaited. The rationale for interventions for children who have been sexually abused is that successful

2012 Campbell Collaboration

127. Interventions to reduce the prevalence of female genital mutilation/cutting in African countries Full Text available with Trip Pro

studies. Baseline similarity of the outcome was a prerequisite. As is also standard, we used Mantel‐Haenszel random effects meta‐analysis for dichotomous outcomes and inverse‐variance random effects meta‐analysis for continuous outcomes. Compared to fixed effects meta‐analysis, random effects meta‐analysis is more conservative, which is reflected in the broader 95%CIs usually observed. We examined between‐study heterogeneity with the Chi‐square (Chi 2 ) and I‐square (I 2 ) tests. We had planned to use

2012 Campbell Collaboration

128. "The Effects of Clinical Pilates Exercises on Cognitive Functions and Speed of Movement in Healthy Young Adults"

Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study, end of the first session, 4th week and end of the study (8th week). Participants in control will keep an activity log. SPSS statistical program will be used for statistical analysis. The Shapiro Wilk test will be performed to determine the normal distribution suitability of the data. The difference between the continuous variables in the groups will be compared with the ANOVA and the Tukey HSD test will be used (...) (Group 1), aerobic exercise group (Group 2), control group (Group 3). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 81 cases in the study.First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test

2018 Clinical Trials

129. Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101-CODIT (Peanut Oral Immunotherapy)

to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a double-blind placebo-controlled food challenge (DBPCFC) at week 28. Secondary objectives are: To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at week 28 To assess (...) vs placebo plus AR101 who "pass" a double-blind, placebo-controlled food challenge (DBPCFC) with (cumulative) peanut protein [ Time Frame: At Week 28 ] Secondary Outcome Measures : Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants treated with dupilumab plus AR101 vs placebo plus AR101 [ Time Frame: Baseline to Week 28 ] Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the dose of AR101 [ Time

2018 Clinical Trials

130. Quantitative Approach Based on Wearable Inertial Sensors to Assess and Identify Motion and Errors in Techniques Used during Training of Transfers of Simulated c-Spine-Injured Patients Full Text available with Trip Pro

is subjective. This paper proposes a quantitative approach to measure the efficacy of the c-spine stabilization and provide objective feedback during training. Methods. 3D wearable motion sensors are positioned on a simulated patient to capture the motion of the head and trunk during a training scenario. Spatial and temporal indicators associated with the motion can then be derived from the signals. The approach was developed and tested on data obtained from 21 paramedics performing the log-roll, a transfer (...) technique commonly performed during prehospital and hospital care. Results. In this scenario, 55% of the c-spine motion could be explained by the difficulty of rescuers to maintain head and trunk alignment during the rotation part of the log-roll and their difficulty to initiate specific phases of the motion synchronously. Conclusion. The proposed quantitative approach has the potential to be used for personalized feedback during training sessions and could even be embedded into simulation mannequins

2018 Journal of healthcare engineering

131. Isolation of the Operative Field Influences the Survival Rate of Composite Restorations

-effectiveness of the restorations and the discomfort reported by the patient (measured using the Wong-Baker scale). The Kaplan-Meier survival analysis and log-rank test will be applied to the survival of the restoration. All variables will be modeled and compared with a Cox regression model of shared fragility. The discomfort reported by the patient will be analyzed by Ordinal Logistic Regression (α = 5%). Condition or disease Intervention/treatment Phase Dental Caries in Children Procedure: Rubber dam (...) (in Brazilian reais), as well as the cost-effectiveness of the restorations and the discomfort reported by the patient (measured using the Wong-Baker scale). The Kaplan-Meier survival analysis and log-rank test will be applied to the survival of the restoration. All variables will be modeled and compared with a Cox regression model of shared fragility. The discomfort reported by the patient will be analyzed by Ordinal Logistic Regression (α = 5%). Study Design Go to Layout table for study information Study

2018 Clinical Trials

132. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. (Abstract)

. Two-year freedom from composite endoleak was high among both cohorts (95% on-IFU vs 92% off-IFU). Freedom from migration was 97.7% on-IFU vs 93.2% off-IFU (P = .0125). Freedom from aneurysm enlargement was 98.1% on-IFU vs 93.5% off-IFU (P value is not available because of failure of log-rank test assumptions). Composite freedom from migration, type IA endoleak, or aneurysm expansion was 95.9% among the on-IFU cohort vs 85.1% in the off-IFU cohort (P = .0017).Consistent with the introduction (...) for selection of patients.Comprehensive engineering evaluations, statistical analyses, and clinical assessments were conducted looking at patients enrolled in the pivotal trial (N = 150), roll-in cohort (N = 29), and continued access program (N = 154). All patients in all cohorts were treated on-IFU at the time of enrollment. Logistic regression models supported the mechanism that migration with Nellix is associated with a small aortic flow lumen relative to a large aneurysm thrombus burden and large aortic

2018 Journal of Vascular Surgery

133. SKY vs. HEP in PTSD

diagnoses will be screened by the MINI (Mini International Neuropsychiatric Interview). The CAPS5 will also be used to rule out severe depersonalization and derealization as per exclusion criteria. If the participant is above the age of 65 years of age, they will complete a cognitive screening test using the Mini Mental State Examination, MMSE>24 to rule out significant cognitive impairment. Participants meeting all study criteria who wish to join the study will be enrolled and assigned a unique study (...) the participants code on the outside, and information about treatment allocation for the participant inside the envelope. Participants will be given this envelope at the end of their baseline assessment and instructed not to open it until they have left their appointment. TRIAL INTERVENTIONS: The investigators will offer the two interventions in groups of 6-8 participants on a rolling basis 1. Sudarshan Kriya Yoga (SKY): 1. Participants in the SKY group will undergo a 12-week training course conducted

2018 Clinical Trials

134. Electronic Cigarettes Full Text available with Trip Pro

Electronic Cigarettes Electronic Cigarettes | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search October 2019 September 2019 August 2019 July 2019 June 2019 May 2019 April 2019 March 2019 February 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use of cookies. Free Access article Share on Jump to Free Access article Electronic Cigarettes A Policy Statement From the American Heart Association , PhD (...) by the manufacturers as high, medium, or low nicotine strength. Some e-liquids are available in 36 mg/mL concentrations. Nicotine solutions of 100 mg/mL for use in making e-cigarette refill liquids are available over the Internet. As a point of context, 1 regular cigarette contains ≈10 to 15 mg of nicotine and delivers a systemic dose of ≈1 mg of nicotine. Testing has revealed that the nicotine content noted in some e-cigarette products and refill solutions has been incorrect and either overestimates

2014 American Heart Association

135. Diagnosis and Treatment of Fetal Cardiac Disease Full Text available with Trip Pro

Diagnosis and Treatment of Fetal Cardiac Disease Diagnosis and Treatment of Fetal Cardiac Disease | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 March 2019 March 2019 March 2019 March 2019 February 2019 February 2019 February 2019 February 2019 January 2019 January 2019 January 2019 January 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use of cookies. Free Access article Share (...) % necessitates additional expenditure of resources and at what level (screening ultrasound or fetal echocardiogram) are topics of debate. The answers vary, depending on the healthcare system environment, skill of screening operators, and available resources. Thus, recommendations for indications for referral for fetal echocardiogram must take into account risk for CHD in individual populations. In general, risk levels of ≥2% to 3% as defined by prenatal screening tests (such as maternal serum screening

2014 American Heart Association

136. Stakeholder Discussion to Reduce Population-Wide Sodium Intake and Decrease Sodium in the Food Supply Full Text available with Trip Pro

Stakeholder Discussion to Reduce Population-Wide Sodium Intake and Decrease Sodium in the Food Supply Stakeholder Discussion to Reduce Population-Wide Sodium Intake and Decrease Sodium in the Food Supply | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 March 2019 March 2019 March 2019 March 2019 February 2019 February 2019 February 2019 February 2019 January 2019 January 2019 January 2019 January 2019 January 2019 This site uses cookies (...) to inflammation. Evidence on the adverse health effects of excess sodium intake includes results from animal studies, epidemiological studies, clinical trials, and meta-analyses of trials. To date, >50 randomized trials have tested the effects of sodium reduction on BP in adults. A meta-analysis of these trials documented that a median reduction in urinary sodium of ≈1800 mg/d lowered systolic and diastolic BP by 2.0 and 1.0 mm Hg, respectively, in nonhypertensive individuals and by 5.0 and 2.7 mm Hg

2014 American Heart Association

137. The Non-Surgical Management of Hip & Knee Osteoarthritis (OA)

in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. These guidelines are not intended to represent TRICARE policy. Further, inclusion of recommendations for specific testing (...) . Therefore, as a tool for routine diagnosis for OA, MRI is not recommended. [28] Clinical Practice Guideline for the Non-Surgical Management of Osteoarthritis Page 21 of 126 A4. Routine Use of Laboratories and Synovial Fluid Analysis Background The literature review revealed little evidence of benefit from laboratory evaluation of blood, urine, or synovial fluid in the evaluation of OA. These relatively few available studies found that laboratory tests or synovial fluid analysis may be of benefit only

2014 VA/DoD Clinical Practice Guidelines

138. Specification, implementation and management of information technology (IT) systems in hospital transfusion laboratories

upgrade to the LIMS ? Electronic Issue is not permitted if test results have been manually edited ? Label attachment verification ? Remote electronic issue ? Section on electronic blood administration (tracking) systems Summary of Recommendations There are a large number of recommendations against which compliance should be assessed. This summary shows the important principles underpinning the recommendations. Adequate control and resources are required to ensure the IT project complies (...) will be archived. This may be done on the basis of time (e.g. data from the last 5 years is migrated and prior data archived) or may be specific to information types depending on the database structure (e.g. it may be more necessary to transfer patient information, blood group and antibody status than test data and component details). Where an existing database is to be split into data for migration and data for archiving careful consideration needs to be given to the boundary cases to ensure there is a clean

2014 British Committee for Standards in Haematology

139. Psychological, social and biological determinants of ill health (pSoBid)

and to the participants themselves. This study was funded by the Glasgow Centre for Population Health which is a partnership between NHS Greater Glasgow and Clyde, Glasgow City Council and the University of Glasgow, supported by the Scottish Government. Jennifer McLean July 2013 3Abbreviations and glossary AVLT Auditory Verbal Learning Test: assesses short-term auditory-verbal memory BMI Body mass index BP Blood pressure CHD Coronary heart disease cIMT Carotid intima-media thickness: a surrogate marker (...) from the most and least deprived communities of Glasgow. This study also illustrates the willingness of subjects to volunteer for a variety of investigations involving psychological, behavioural, sociological and medical questions and tests. The depth and range of the data collected and the analyses undertaken in this study yield important information concerning the relationships between health and socioeconomic status, inflammation, atherosclerosis, mental outlook, cognitive performance

2013 Glasgow Centre for Population Health

140. March 2014 supplement to the 2013 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection

– Guidance on operations and service delivery, including rolling out viral load testing, procurement and supply chain management concerns and community models of ART delivery; and Chapter 11 – Monitoring and evaluation, including surveillance of ARV drug toxicity monitoring and surveillance of drug resistance. WHO will issue the next supplement to the consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection in the second half of 2014. This later supplement (...) of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in Switzerland5 CONTENTS 6 7 8 11 12 17 32 37 43 55 58 69 75 77 81 86 94 100 105 Abbreviations and acronyms Foreword Acknowledgements Executive summary Supplementary sections to Chapter 5 – HIV diagnosis and ARV drugs for HIV prevention 1. HIV self-testing 2. New strategies for diagnosing HIV infection among infants Supplementary sections to Chapter 7 – Antiretroviral

2014 World Health Organisation HIV Guidelines

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