82 results
Search Results
2. Nutritional intervention and neurodevelopmental outcome in infants with suspected cerebral palsy: the Dolphin infant double-blind randomized controlled trial.
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Andrew, Morag J., Montague‐Johnson, Christine, Laler, Karen, Baker, Bonny, Sullivan, Peter B., Parr, Jeremy R., Qi, Cathy, and Montague-Johnson, Christine
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NEURODEVELOPMENTAL treatment for infants ,CEREBRAL palsy ,DOCOSAHEXAENOIC acid ,NUTRITION ,RANDOMIZED controlled trials ,CEREBRAL palsy treatment ,NUCLEOTIDES ,CHOLINE ,CHILD development ,COMPARATIVE studies ,DIET therapy ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,BLIND experiment ,DISEASE complications ,PSYCHOLOGY ,THERAPEUTICS - Abstract
Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2018
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3. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.
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Wolff, Ulrika
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SHORT-term memory ,PRE-tests & post-tests ,ACTIVITY programs in education ,CLASSROOM activities ,ELEMENTARY schools ,ELEMENTARY school teachers ,ELEMENTARY education ,SCHOOL children ,DYSLEXIA ,COMPARATIVE studies ,LANGUAGE & languages ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,READABILITY (Literary style) ,READING ,RESEARCH ,STUDENTS ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PSYCHOLOGY ,THERAPEUTICS - Abstract
The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]
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- 2016
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4. Guidelines for the Reporting of Treatment Trials for Alcohol Use Disorders.
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Witkiewitz, Katie, Finney, John W., Harris, Alex H. S., Kivlahan, Daniel R., and Kranzler, Henry R.
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ALCOHOL-induced disorders ,CLINICAL trials ,EXPERIMENTAL design ,MEDICAL cooperation ,MEDICAL protocols ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,PATIENT participation ,SYSTEMATIC reviews ,SAMPLE size (Statistics) ,ELIGIBILITY (Social aspects) ,DATA analysis ,RANDOMIZED controlled trials ,CLINICAL trial registries ,HUMAN research subjects ,PATIENT selection ,THERAPEUTICS - Abstract
Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]
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- 2015
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5. Youth recovery outcomes at 6 and 9 months following participation in a mobile texting recovery support aftercare pilot study.
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Gonzales, Rachel, Hernandez, Mayra, Murphy, Debra A., and Ang, Alfonso
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BEHAVIORAL assessment of teenagers ,ADOLESCENT psychology ,TEXT messages ,GROUP psychotherapy for youth ,SUBSTANCE-induced disorders ,THERAPEUTICS ,SUBSTANCE abuse treatment ,COMPARATIVE studies ,HEALTH behavior ,PATIENT aftercare ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,SELF-efficacy ,TIME ,DISEASE relapse ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness - Abstract
Background and Objectives: We examined youth recovery outcomes at 6- and 9-months post-participation in an aftercare pilot study called Educating and Supporting inQuisitive Youth in Recovery (ESQYIR) that aimed to investigate the utility of a 12-week mobile texting recovery support intervention.Methods: A total of 80 youth [Mage 20.4 (SD = 3.5)] were randomized to a mobile texting aftercare intervention or an aftercare-as-usual control group. Both groups received identical data collection protocols with psychosocial and behavioral assessments occurring at baseline, during the trial (months 1 and 2), at discharge from the trial (month 3), and 3-, 6-, and 9-month post-intervention follow-ups.Results: Mixed modeling showed that youth who participated in the mobile texting aftercare intervention were less likely to test positive for their primary drug compared to youth in the aftercare-as-usual condition during 6- and 9-months follow-ups (p < .01). Additionally, youth in the aftercare intervention reported significantly higher self-efficacy/confidence to abstain during recovery (p < .05) and were more likely to participate in recovery-related behaviors (self-help and goal-directed extracurricular activities; p < .05) than those in aftercare-as-usual at the 6- and 9-month follow-ups.Conclusions: Results suggest that delivering a structured, behavioral-based wellness aftercare intervention using mobile texting can be an effective for sustaining recovery outcomes in youth over time compared to youth who receive aftercare-as-usual.Scientific Significance: This study shows that a mobile-texting aftercare intervention sustained effects at 6- and 9-months post-intervention for young people in substance use recovery. [ABSTRACT FROM AUTHOR]- Published
- 2016
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6. Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single‐blind, combined split‐mouth and parallel‐arm randomized controlled trial
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Smaïl‐Faugeron, Violaine, Muller‐Bolla, Michèle, Sixou, Jean‐Louis, and Courson, Frédéric
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DENTAL anesthesia ,CHILDREN'S dental care ,CONFIDENCE intervals ,MEDICAL cooperation ,PAIN ,PEDIATRIC dentistry ,RESEARCH ,STATISTICAL sampling ,THERAPEUTICS ,PAIN management ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,INTRAOSSEOUS infusions ,CHILDREN - Abstract
Background: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies. Aim: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children. Design: We used an innovative design consisting in simultaneously conducting a multicentre split‐mouth and parallel‐arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0‐10 cm) concerning the insertion of the needle and injection. Results: A total of 30 children were included in the split‐mouth RCT and 128 in the parallel‐arm RCT. We combined treatment effect estimates by using an inverse‐variance weighting meta‐analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference −0.69 cm, 95% confidence intervals −1.13 to −0.25 cm). For each patient enrolled in the split‐mouth RCT, about five were enrolled in the parallel‐arm RCT, which allowed for not losing any eligible patients. Conclusion: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433). [ABSTRACT FROM AUTHOR]
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- 2019
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7. Randomized controlled trial of emotionally focused couple therapy compared to treatment as usual for depression: Outcomes and mechanisms of change.
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Wittenborn, Andrea K., Liu, Ting, Ridenour, Ty A., Lachmar, E. Megan, Mitchell, Erica A., and Seedall, Ryan B.
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EMOTION-focused therapy ,RANDOMIZED controlled trials ,STRUCTURAL equation modeling ,COUPLES therapy ,THERAPEUTICS ,COMPARATIVE studies ,MENTAL depression ,EMOTIONS ,RESEARCH methodology ,MEDICAL cooperation ,PSYCHOTHERAPY ,RESEARCH ,EVALUATION research ,TREATMENT effectiveness - Abstract
This randomized controlled trial examined the effectiveness of Emotionally Focused Therapy (EFT) for depression and relationship satisfaction versus usual care (i.e., couple therapy other than EFT), and explored mechanisms of change. Mixed model trajectory analyses of 16 couples indicated EFT was associated with greater improvement in relationship satisfaction among men and women. Men receiving EFT reported greater improvements in depressive symptoms compared to usual care. Unified structural equation modeling revealed changes in relationship satisfaction preceded changes in depressive symptoms in one cluster of partners, while changes in depression preceded changes in relationship satisfaction in a second cluster. Two other clusters reported simultaneous changes in satisfaction and depression. This study provides encouraging results on the effectiveness of EFT for depression, and insight into mechanisms of change. [ABSTRACT FROM AUTHOR]
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- 2019
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8. Flaminal® versus Flamazine® in the treatment of partial thickness burns: A randomized controlled trial on clinical effectiveness and scar quality (FLAM study).
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Krijnen, Pieta, Schipper, Inger B., Rashaan, Zjir M., Kwa, Kelly A.A., Breederveld, Roelf S., and Vlies, Cornelis H.
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SILVER sulfadiazine ,BACTERICIDES ,ALGINATES ,BURNS & scalds ,MEDICAL cooperation ,RESEARCH ,SCARS ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,ANTIMICROBIAL bandages ,THERAPEUTICS - Abstract
Although partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical effectiveness and scar quality of Flaminal® Forte to silver sulfadiazine (Flamazine®) in the treatment of partial thickness burns. In this two‐arm open label multicenter randomized controlled trial, adult patients with acute partial thickness burns and an affected total body surface area of less than 30% were randomized between Flaminal® Forte and Flamazine® and followed for 12 months. Dressing changes in the Flamazine® group were performed daily, and in the Flaminal® group during the first 3 days post burn and thereafter every other day until complete wound healing or surgery. Forty‐one patients were randomly allocated to Flaminal® Forte and 48 patients to Flamazine®. The primary outcome was time to wound healing, which did not differ between the groups: median 18 days with Flaminal® Forte (range 8–49 days) versus 16 days with Flamazine® (range 7–48 days; p = 0.24). Regarding the secondary outcomes during hospital admission, there were no statistically significant differences between the groups concerning need for surgery, pain scores, pruritus, or pain‐related and anticipatory anxiety. More patients in the Flaminal® group developed wound colonization (78% versus 32%, p < 0.001), but the treatment groups did not differ regarding the incidence of local infections and use of systemic antibiotics. In terms of scar quality, no statistically significant differences between both treatment groups were found regarding subjective scar assessment (Patient and Observer Scar Assessment Scale (POSAS)), scar melanin and pigmentation (DermaSpectrometer®), and scar elasticity and maximal extension (Cutometer®) during 12 month postburn. In conclusion, time to wound healing did not differ, but the use of Flaminal® Forte seemed favorable because less dressing changes are needed which lowers the burden of wound care. [ABSTRACT FROM AUTHOR]
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- 2019
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9. The Effect of Beginning Treatment With Fremanezumab on Headache and Associated Symptoms in the Randomized Phase 2 Study of High Frequency Episodic Migraine: Post‐Hoc Analyses on the First 3 Weeks of Treatment.
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Silberstein, Stephen D., Rapoport, Alan M., Loupe, Pippa S., Aycardi, Ernesto, McDonald, Mirna, Yang, Ronghua, and Bigal, Marcelo E.
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CALCITONIN ,CONFIDENCE intervals ,MEDICAL cooperation ,MIGRAINE ,NAUSEA ,RESEARCH ,STATISTICS ,VISION disorders ,VOMITING ,HYPERACUSIS ,DATA analysis ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,TREATMENT duration ,SYMPTOMS ,THERAPEUTICS - Abstract
Background: Migraine has a substantial impact on daily living, affecting productivity and quality of life for patients and their families. Patients frequently discontinue preventive medications in part because of a delay in headache and symptom relief due to the long dose titration procedures necessary for some migraine preventives. Objective: To evaluate the efficacy of fremanezumab, a selective monoclonal CGRP ligand antibody, during the first 3 weeks of therapy in patients with high‐frequency episodic migraine (HFEM) to relieve migraine headaches and associated symptoms and to reduce use of acute migraine medications. Methods: In a multicenter, randomized, double‐blind, placebo‐controlled, phase 2 study, patients with HFEM who met inclusion criteria and were 80% compliant with daily headache diary entry were randomized and treated once every 28 days for 3 months with either placebo or fremanezumab 225 or 675 mg. Compared to placebo, both doses of fremanezumab significantly reduced the primary endpoint of the HFEM study, change in the number of migraine days in month 3 relative to baseline. Herein, we performed post‐hoc analyses to assess the efficacy of each dose during the first 3 weeks of treatment to reduce migraine headache parameters, associated migraine symptoms, and the consumption of acute migraine medications. Results: The sample consisted of 297 study participants. Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of −0.93 (95% CI: −1.36, −0.49) and between 675 mg dose and placebo of −1.02 (95% CI: −1.46, −0.58), both P < .0001. This benefit was maintained through the second week of therapy for the 225 and 675 mg doses, respectively, (−0.76 (95% CI: −1.11, −0.40) P < .0001, −.79 (95% CI: −1.15, −0.44) P < .0001) and the third week of therapy (−0.64 (95% CI: −0.97, −0.30) P = .0003 and −0.64 (95% CI: −0.98, −0.30) P = .0003). Likewise in the first week, patients recorded reductions in associated migraine symptoms such as nausea, vomiting, photophobia, and phonophobia, which continued through weeks 2 and 3. There were also reductions in days with acute medication use to treat migraine for the 225 and 675 mg fremanezumab doses compared to placebo. In the first week, LSM differences between 225 mg and placebo were −1.02 (95% CI: −1.39, −0.64) and between 675 mg and placebo were −1.06 (95% CI: −1.39, −0.64) P < .0001); for the second and third weeks (−1.01 (95% CI: −1.14, −0.55) P < .0001; −.90 (95% CI: −1.04, −0.44) P < .0001; −.91 (95% CI: −0.92, −0.34) P < .0001; and −.83 (95% CI: −0.84, −0.26) P = .0002), respectively. Conclusion: Fremanezumab treatment resulted in a rapid preventive response in patients with HFEM, with reductions seen in several headache parameters and migraine symptoms within the first week after therapy initiation and continuing during the second and third weeks. Patients also were able to rapidly reduce their use of acute medications to treat migraine attacks. The trial is registered at Clinicaltrials.gov as NCT02025556. [ABSTRACT FROM AUTHOR]
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- 2019
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10. Randomized double-blind trial of amifostine versus placebo for radiation-induced xerostomia in patients with head and neck cancer.
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Lee, Maverick GL, Roos, Daniel E, Freeman, Amanda R, Borg, Martin F, and Milner, Alvin D
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ETHIOFOS ,HEAD & neck cancer ,RADIOTHERAPY ,RANDOMIZED controlled trials ,XEROSTOMIA ,RADIATION-protective agents ,COMPARATIVE studies ,HEAD tumors ,RESEARCH methodology ,MEDICAL cooperation ,NECK tumors ,RESEARCH ,SURVIVAL ,EVALUATION research ,TREATMENT effectiveness ,BLIND experiment ,PREVENTION ,THERAPEUTICS - Abstract
Introduction: The role of the radioprotector amifostine in ameliorating radiotherapy side effects in head and neck squamous cell carcinoma (HNSCC) is controversial. This trial aimed to determine whether pretreatment with amifostine reduced the incidence of Radiation Therapy Oncology Group grade ≥2 acute and late xerostomia in patients receiving definitive or adjuvant radiotherapy for HNSCC, without reducing tumour control or survival.Methods: Between 14 September 2001 and 8 November 2004, 44 Royal Adelaide Hospital patients were randomized double-blind to receive amifostine (200 mg/m2 IV) or placebo (normal saline IV) 5 days/week, prior to standard radiotherapy (60-70 Gy), each having ≥75% of the parotids treated to ≥40 Gy. Side effects were assessed weekly during treatment, at 3 and 5 months after radiotherapy, then every 6 months until disease progression or death.Results: The accrual target was 200 patients over 4-5 years, but the trial closed prematurely when only 44 patients had been randomized after 3 years. Of 41 evaluable patients, 80% (16/20) in the amifostine arm had grade ≥2 acute radiation salivary toxicity versus 76% (16/21) in the placebo arm (P = 1.00). The rate of grade ≥2 late radiation salivary toxicity at 12 months was 66% in the amifostine arm and 82% in the placebo arm (estimated hazard ratio 1.61, 95% confidence interval 0.74-3.49, P = 0.22). Other toxicities tended to be worse in the amifostine arm: acute grade 3-4 skin 35% vs 5% and mucous membrane 40% vs 5%; grade ≥2 vomiting 35% vs 5%, hypocalcaemia 25% vs 5% and fatigue 85% vs 33%, with only the latter retaining statistical significance after adjusting for multiple comparisons. There were no significant differences in failure-free (P = 0.70) or overall survival (P = 0.86), with estimated 4-year rates of 48% vs 54% and 49% vs 59% for the amifostine vs placebo arms respectively.Conclusion: There was no clear evidence that pretreatment with amifostine made any difference to the incidence of grade ≥2 acute or late xerostomia. Other toxicity tended to be more severe with amifostine. There was no effect on failure-free or overall survival. Acknowledging the low statistical power, these results do not support the use of IV amifostine pre-radiotherapy in HNSCC. [ABSTRACT FROM AUTHOR]- Published
- 2019
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11. Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial.
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Bellad, MB, Hoffman, MK, Mallapur, AA, Charantimath, US, Katageri, GM, Ganachari, MS, Kavi, A, Ramdurg, UY, Bannale, SG, Revankar, AP, Sloan, NL, Kodkany, BS, Goudar, SS, Derman, RJ, Bellad, M B, Hoffman, M K, Mallapur, A A, Charantimath, U S, Katageri, G M, and Ganachari, M S
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CLINDAMYCIN ,PREMATURE labor prevention ,PREGNANT women ,MISCARRIAGE ,STILLBIRTH ,ANTIBIOTICS ,BACTERIAL vaginitis ,COMMUNICABLE diseases ,COMPARATIVE studies ,GESTATIONAL age ,PREMATURE infants ,RESEARCH methodology ,MEDICAL cooperation ,MEDICALLY underserved areas ,ORAL drug administration ,PREGNANCY complications ,PRENATAL care ,RESEARCH ,RURAL population ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DISEASE incidence ,BLIND experiment ,THERAPEUTICS ,PREVENTION - Abstract
Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]- Published
- 2018
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12. An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial.
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Zelen, Charles M., Orgill, Dennis P., Serena, Thomas E., Galiano, Robert E., Carter, Marissa J., DiDomenico, Lawrence A., Keller, Jennifer, Kaufman, Jarrod P., and Li, William W.
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DIABETIC foot ,CHRONIC wounds & injuries ,COMBINED modality therapy ,COST effectiveness ,DERMIS ,HOMOGRAFTS ,LONGITUDINAL method ,MEDICAL quality control ,MEDICAL care costs ,MEDICAL cooperation ,MEDICAL screening ,MEETINGS ,RESEARCH ,WOUND healing ,RANDOMIZED controlled trials ,DISEASE incidence ,ADVERSE health care events ,SURGERY ,THERAPEUTICS - Abstract
Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing diabetic foot ulcers. [ABSTRACT FROM AUTHOR]
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- 2018
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13. Characteristics of high‐ and low‐risk individuals in the PRIORITY study: urinary proteomics and mineralocorticoid receptor antagonism for prevention of diabetic nephropathy in Type 2 diabetes.
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Tofte, N., Lindhardt, M., Frimodt‐Møller, M., Persson, F., Rossing, P., Dimos, I., Francová, L., Rychlík, I., Girman, P., Havrdova, T., Göke, R., Kooy, A., Mischak, H., Navis, G., Nijpels, G., Noutsou, M., Ortiz, A., Adamova, K., Parvanova, A., and Ruggenenti, P. L.
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DIABETIC nephropathies ,HORMONE antagonists ,TYPE 2 diabetes complications ,BIOMARKERS ,CONFIDENCE intervals ,CREATININE ,GLOMERULAR filtration rate ,LONGITUDINAL method ,MEDICAL cooperation ,MINERALOCORTICOIDS ,SCIENTIFIC observation ,RESEARCH ,SEX distribution ,STATISTICS ,LOGISTIC regression analysis ,PROTEOMICS ,RENIN-angiotensin system ,ALBUMINS ,RANDOMIZED controlled trials ,BLIND experiment ,DISEASE duration ,CHEMICAL inhibitors ,PROGNOSIS ,PREVENTION ,THERAPEUTICS ,DISEASE risk factors - Abstract
Abstract: Aim: To compare clinical baseline data in individuals with Type 2 diabetes and normoalbuminuria, who are at high or low risk of diabetic kidney disease based on the urinary proteomics classifier CKD273. Methods: We conducted a prospective, randomized, double‐blind, placebo‐controlled international multicentre clinical trial and observational study in participants with Type 2 diabetes and normoalbuminuria, stratified into high‐ or low‐risk groups based on CKD273 score. Clinical baseline data for the whole cohort and stratified by risk groups are reported. The associations between CKD273 and traditional risk factors for diabetic kidney disease were evaluated using univariate and logistic regression analysis. Results: A total of 1777 participants from 15 centres were included, with 12.3% of these having a high‐risk proteomic pattern. Participants in the high‐risk group (n=218), were more likely to be men, were older, had longer diabetes duration, a lower estimated GFR and a higher urinary albumin:creatinine ratio than those in the low‐risk group (n=1559, P<0.02). Numerical differences were small and univariate regression analyses showed weak associations (R
2 < 0.04) of CKD273 with each baseline variable. In a logistic regression model including clinical variables known to be associated with diabetic kidney disease, estimated GFR, gender, log urinary albumin:creatinine ratio and use of renin‐angiotensin system‐blocking agents remained significant determinants of the CKD273 high‐risk group: area under the curve 0.72 (95% CI 0.68–0.75; P<0.01). Conclusions: In this population of individuals with Type 2 diabetes and normoalbuminuria, traditional diabetic kidney disease risk factors differed slightly between participants at high risk and those at low risk of diabetic kidney disease, based on CKD273. These data suggest that CKD273 may provide additional prognostic information over and above the variables routinely available in the clinic. Testing the added value will be subject to our ongoing study. (European Union Clinical Trials Register: EudraCT 2012‐000452‐34 and Clinicaltrials.gov: NCT02040441). [ABSTRACT FROM AUTHOR]- Published
- 2018
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14. Incremental benefit of drug therapies for chronic heart failure with reduced ejection fraction: a network meta-analysis.
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Komajda, Michel, Böhm, Michael, Borer, Jeffrey S., Ford, Ian, Tavazzi, Luigi, Pannaux, Matthieu, and Swedberg, Karl
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HEART failure ,META-analysis ,RANDOMIZED controlled trials ,DRUG therapy ,CARDIAC arrest ,CARDIOVASCULAR agents ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL protocols ,RESEARCH ,RESEARCH funding ,SYSTEMATIC reviews ,EVALUATION research ,TREATMENT effectiveness ,STROKE volume (Cardiac output) ,THERAPEUTICS - Abstract
Aims: A network meta-analysis (NMA) of all recommended drug groups for the treatment of heart failure with reduced ejection fraction (HFrEF), including their combinations, was performed to assess the relative efficacy and incremental benefit.Methods and Results: A search was made in biomedical databases for randomized controlled trials published between 1987 and 2017 on angiotensin-converting enzyme inhibitors (ACEIs), beta-blockers (BBs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), ivabradine (IVA), or angiotensin receptor-neprilysin inhibitors (ARNI). A total of 58 relevant trials were identified. The relative efficacy of each treatment group (or combination) in terms of all-cause mortality, cardiovascular mortality, all-cause hospitalizations and hospitalizations for heart failure, per patient-year of follow-up, were combined in a random-effects Bayesian NMA. The pairwise comparison between each regimen and for each outcome was estimated. The NMA was dominated by 15 large-scale trials with between 1984 and 18 898 patient-years of follow-up. Combinations of drug groups showed incremental benefits on outcomes over single groups. The most effective combinations were ARNI+BB + MRA and ACEI+BB + MRA + IVA, showing reductions in all-cause mortality (vs. placebo) of 62% and 59%, respectively; hazard ratios were 0.38 [credible interval (CrI) 0.20-0.65] and 0.41 (CrI 0.21-0.70); and in all-cause hospitalizations with reductions of 42% for both. These two combinations were also the most effective for the other outcomes studied.Conclusion: Our analysis shows that the incremental use of combinations of disease-modifying therapies has resulted in the progressive improvement in mortality and hospitalization outcomes in HFrEF. Our findings support the current guideline recommendations. [ABSTRACT FROM AUTHOR]- Published
- 2018
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15. PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.
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Laufs, Ulrich, Griese‐Mammen, Nina, Krueger, Katrin, Wachter, Angelika, Anker, Stefan D., Koehler, Friedrich, Rettig‐Ewen, Volker, Botermann, Lea, Strauch, Dorothea, Trenk, Dietmar, Böhm, Michael, Schulz, Martin, Griese-Mammen, Nina, and Rettig-Ewen, Volker
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HEART failure ,RANDOMIZED controlled trials ,HOSPITAL care ,OUTPATIENT medical care ,DRUG therapy ,ADRENERGIC beta blockers ,ACE inhibitors ,ANGIOTENSIN receptors ,COMBINATION drug therapy ,COMPARATIVE studies ,DRUGS ,INTERDISCIPLINARY education ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,PATIENT compliance ,RESEARCH ,STATISTICAL sampling ,PILOT projects ,EVALUATION research ,TREATMENT effectiveness ,THERAPEUTICS - Abstract
We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. [ABSTRACT FROM AUTHOR]
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- 2018
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16. Pilot study of acupuncture to treat anxiety in children and adolescents.
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Leung, Brenda, Takeda, Wendy, and Holec, Victoria
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ACUPUNCTURE ,ANXIETY in children ,GENERALIZED anxiety disorder ,ANXIETY treatment ,RANDOMIZED controlled trials ,THERAPEUTICS ,ANXIETY disorders treatment ,AGE distribution ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,PATIENT compliance ,PROGNOSIS ,PSYCHOLOGICAL tests ,QUALITY of life ,REFERENCE values ,RESEARCH ,RISK assessment ,SEX distribution ,PILOT projects ,EVALUATION research ,ANXIETY disorders ,TREATMENT effectiveness ,BLIND experiment ,SEVERITY of illness index - Abstract
Aim: This pilot study investigated the use of acupuncture in the treatment of paediatric anxiety.Methods: Children with anxiety, aged 8-16, were randomised to either the acupuncture or waitlist control groups. Anxiety was measured using the Hamilton Anxiety Rating Scale (HAM-A) for children and adolescents with generalised anxiety disorder and Multidimensional Anxiety Scale for Children 2nd Edition (MASC-2) self-rated and parent-rated forms.Results: Twenty participants were enrolled in the study and 19 completed all the questionnaires to be included in the analysis. There were no differences in socio-demographic characteristics at baseline between the two groups. At the second assessment, the mean MASC-parent score for the acupuncture group was significantly lower than the waitlist group (65.6 (SD 15.0) compared to 81.0 (SD 11.9), P = 0.025) with an effect size = 1.13. The pre- and post-treatment comparisons were also significantly lower for both groups in the anxiety measures. In the acupuncture group, MASC-parent (P = 0.008, effect size 0.75) and the HAM-A (P < 0.001, effect size 1.4). In the waitlist group, MASC-self (P = 0.022; effect size 0.4), MASC-parent (P = 0.048; effect size 0.75) and HAM-A (P = 0.007; effect size 1.21).Conclusions: This study provided promising results on the potential use of acupuncture to treat children and adolescents with general anxiety. Future research using a randomised control trial with a sufficient sample size to control for confounders and sham (placebo) comparators is warranted. [ABSTRACT FROM AUTHOR]- Published
- 2018
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17. Subclinical cardiovascular disease in patients starting contemporary protease inhibitors.
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González‐Cordón, A., Doménech, M., Camafort, M., Martínez‐Rebollar, M., Torres, B., Laguno, M., Rojas, J., Loncà, M., Blanco, J. L., Mallolas, J., Gatell, J. M., de Lazzari, E., and Martínez, E.
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AORTA physiology ,THERAPEUTIC use of protease inhibitors ,ANTIRETROVIRAL agents ,EMTRICITABINE ,DARUNAVIR ,ATAZANAVIR ,TENOFOVIR ,RITONAVIR ,BIOMARKERS ,CARDIOVASCULAR diseases ,CARDIOVASCULAR diseases risk factors ,CONFIDENCE intervals ,CLINICAL drug trials ,HIV ,HIV infections ,MEDICAL cooperation ,MULTIVARIATE analysis ,REGRESSION analysis ,RESEARCH ,PILOT projects ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DISEASE progression ,CAROTID intima-media thickness ,THERAPEUTICS - Abstract
Objectives: The aim of the study was to assess changes in and factors associated with anatomical [carotid artery intima‐media thickness (CIMT)] and functional (arterial stiffness) markers of subclinical cardiovascular disease progression in antiretroviral‐naïve patients starting triple combination antiretroviral therapy containing contemporary protease inhibitors. Methods: This was a planned substudy of the ATADAR (Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV‐1 Infected Patients) clinical trial (ClinicalTrials.gov identifier NCT01274780). ATADAR is a multicentre, randomized, open‐label clinical trial comparing the effects of ritonavir‐boosted atazanavir and darunavir, both with tenofovir/emtricitabine, in antiretroviral‐naïve HIV‐infected patients. Common CIMT and aortic augmentation index (AIx@75) were measured at baseline and after 12 months of follow‐up. Antiretroviral treatment, traditional cardiovascular risk factors and HIV‐related factors were assessed as potential predictors of CIMT and Aix@75 changes using linear regression analysis. Results: Thirty‐three patients were included in this pilot study. While CIMT significantly increased in the pooled population [median (interquartile range (IQR)) 68 (−13, 128) μm; P = 0.0511], AIx@75 did not [median (IQR) 1 (−6, 5)%; P = 0.8964]. Patients on darunavir showed a trend to faster CIMT progression than those on atazanavir [median change (IQR) 117 (−2, 143) vs. −6 (−58, 89) μm, respectively; P = 0.0917]. However, after adjustment in the multivariate analysis, a higher baseline Framingham score was the only factor associated with CIMT progression (coefficient 16.02; 95% confidence interval –1.04, 33.08; P = 0.064). AIx@75 change was not associated with any baseline factor. Conclusions: CIMT was a more sensitive marker of subclinical vascular disease progression than arterial stiffness in antiretroviral‐naïve patients starting antiretroviral therapy with contemporary protease inhibitors. Classical risk factors but not antiretroviral therapy were associated with faster CIMT progression. [ABSTRACT FROM AUTHOR]
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- 2018
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18. Blood pressure lowering and anti-inflammatory effects of hesperidin in type 2 diabetes; a randomized double-blind controlled clinical trial.
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Homayouni, Fatemeh, Haidari, Fatemeh, Hedayati, Mehdi, Zakerkish, Mehrnoosh, and Ahmadi, Kambiz
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REACTIVE oxygen species ,BLOOD pressure ,COMPARATIVE studies ,ANTIHYPERTENSIVE agents ,RESEARCH methodology ,MEDICAL cooperation ,TYPE 2 diabetes ,RESEARCH ,OXIDATIVE stress ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,FLAVANONES ,PHARMACODYNAMICS ,THERAPEUTICS - Abstract
Elevated levels of reactive oxygen species under diabetic condition lead to vascular complications and inflammation. This study aimed to examine the effects of hesperidin supplement on blood pressure and inflammatory markers in type 2 diabetes. In this research, 64 patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on systolic blood pressure (SBP), diastolic blood pressure, serum total antioxidant capacity (TAC), tumor necrosis factor alpha, interleukin 6 (IL-6), and high-sensitivity C-reactive protein (hs-CRP) were collected at the baseline and at the end of the study. In the hesperidin group, SBP (122.7 ± 8.5 vs. 119.0 ± 7.4; p = .005), mean arterial blood pressure (94.2 ± 5.5 vs. 91.8 ± 5.5; p = .009), IL-6 (8.3 ± 2.1 vs. 7.4 ± 1.8; p = .001), and hs-CRP (1.9 ± 1.2 vs. 1.1 ± 0.9; p < .000) decreased whereas TAC increased (0.74 ± 0.1 vs. 0.82 ± 0.1; p < .000) in comparison to the baseline values. There was a significant difference in mean percent change of SBP, diastolic blood pressure, mean arterial blood pressure, serum TAC, and inflammatory markers (tumor necrosis factor alpha, IL-6, and hs-CRP) between hesperidin and control groups following intervention in adjusted models (p < .05). These results suggest that hesperidin may have antihypertensive and anti-inflammatory effects in type 2 diabetes. [ABSTRACT FROM AUTHOR]
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- 2018
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19. Curcumin nanomicelle improves semen parameters, oxidative stress, inflammatory biomarkers, and reproductive hormones in infertile men: A randomized clinical trial.
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Alizadeh, Fatemeh, Javadi, Maryam, Karami, Ali Akbar, Gholaminejad, Fereshteh, Kavianpour, Maria, and Haghighian, Hossein Khadem
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COMPARATIVE studies ,INFERTILITY ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,SEMEN ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,CURCUMIN ,SPERM count ,THERAPEUTICS - Abstract
At least 50% of infertile couple's problems are related to male factor infertility. This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted in Urology unit of Infertility Clinic on 60 infertile men. Patients were randomly assigned to one of intervention and placebo (n = 30) groups. Finally, 28 subjects in each group completed the study. Participants in the intervention group took daily 80 mg curcumin nanomicelle and those in the placebo group took daily placebo for 10 weeks. Semen analysis, anthropometric, physical activity assessments, total antioxidant capacity, malondialdehyde, inflammatory factors, and reproductive hormones were measured at the baseline and at the end of the study. At the end of study, statistically significant differences were seen in the total sperm count, sperm concentration, and motility in the intervention group to the control group. In treatment group, the total sperm count, sperm concentration, and motility levels were also statistically increased at the end of study compared to the baseline values. Curcumin nanomicelle supplementation also resulted in a statistically significant improvement in plasma levels of total antioxidant capacity, malondialdehyde, C-reactive protein, and tumor necrosis factor a in comparison to the placebo. Medical therapy of asthenoteratospermia with curcumin nanomicelle supplement could improve quality of semen parameters. However, further investigation is suggested in this regard. [ABSTRACT FROM AUTHOR]
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- 2018
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20. Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).
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Katakami, Nobuyuki, Uchino, Junji, Yokoyama, Takuma, Naito, Tateaki, Kondo, Masashi, Yamada, Kouzo, Kitajima, Hiromoto, Yoshimori, Kozo, Sato, Kazuhiro, Saito, Hiroshi, Aoe, Keisuke, Tsuji, Tetsuya, Takiguchi, Yuichi, Takayama, Koichi, Komura, Naoyuki, Takiguchi, Toru, and Eguchi, Kenji
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NON-small-cell lung carcinoma ,CANCER treatment ,PLACEBOS ,RANDOMIZED controlled trials ,ANOREXIA nervosa ,DIAGNOSIS ,DISEASE risk factors ,BODY composition ,CACHEXIA ,COMPARATIVE studies ,LUNG cancer ,LUNG tumors ,RESEARCH methodology ,MEDICAL cooperation ,OLIGOPEPTIDES ,ORGANIC compounds ,RESEARCH ,EVALUATION research ,BLIND experiment ,THERAPEUTICS - Abstract
Background: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.Methods: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.Results: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and -0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients.Conclusions: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. [ABSTRACT FROM AUTHOR]- Published
- 2018
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21. A Ketone Ester Drink Lowers Human Ghrelin and Appetite.
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Stubbs, Brianna J., Cox, Pete J., Evans, Rhys D., Cyranka, Malgorzata, Clarke, Kieran, and de Wet, Heidi
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KETONES ,GHRELIN ,WEIGHT loss ,DIET ,BLOOD sampling ,BEVERAGE analysis ,APPETITE ,CARBOXYLIC acids ,COMPARATIVE studies ,CROSSOVER trials ,HUNGER ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,THERAPEUTICS - Abstract
Objective: The ketones d-β-hydroxybutyrate (BHB) and acetoacetate are elevated during prolonged fasting or during a "ketogenic" diet. Although weight loss on a ketogenic diet may be associated with decreased appetite and altered gut hormone levels, it is unknown whether such changes are caused by elevated blood ketones. This study investigated the effects of an exogenous ketone ester (KE) on appetite.Methods: Following an overnight fast, subjects with normal weight (n = 15) consumed 1.9 kcal/kg of KE, or isocaloric dextrose (DEXT), in drinks matched for volume, taste, tonicity, and color. Blood samples were analyzed for BHB, glucose, insulin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide tyrosine tyrosine (PYY), and a three-measure visual analogue scale was used to measure hunger, fullness, and desire to eat.Results: KE consumption increased blood BHB levels from 0.2 to 3.3 mM after 60 minutes. DEXT consumption increased plasma glucose levels between 30 and 60 minutes. Postprandial plasma insulin, ghrelin, GLP-1, and PYY levels were significantly lower 2 to 4 hours after KE consumption, compared with DEXT consumption. Temporally related to the observed suppression of ghrelin, reported hunger and desire to eat were also significantly suppressed 1.5 hours after consumption of KE, compared with consumption of DEXT.Conclusions: Increased blood ketone levels may directly suppress appetite, as KE drinks lowered plasma ghrelin levels, perceived hunger, and desire to eat. [ABSTRACT FROM AUTHOR]- Published
- 2018
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22. Possible therapeutic effect of carvacrol on asthmatic patients: A randomized, double blind, placebo-controlled, Phase II clinical trial.
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Alavinezhad, Azam, Khazdair, Mohammad Reza, and Boskabady, Mohammad Hossein
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DRUG therapy for asthma ,ANIMAL experimentation ,CLINICAL trials ,COMPARATIVE studies ,HYDROCARBONS ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,PULMONARY function tests ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,THERAPEUTICS - Abstract
The relaxant effects of carvacrol, a phenolic monoterpene, on tracheal smooth muscle and its preventive effect on asthmatic animals were reported. The effect of carvacrol in asthmatic patients was examined in the placebo group (Group P, n = 11) receiving placebo and treatment group (Group C, n = 12), which received carvacrol capsule (1.2 mg/kg/day) for 2 months in a double-blind manner. Pulmonary function tests, respiratory symptoms, hematological indices, and high-sensitivity C-reactive protein (hs-CRP) were measured before, 1 and 2 months after starting treatment. At the end of treatment period, Pulmonary function tests values in Group C were significantly increased (p < .05 to p < .001). Most respiratory symptoms were also significantly reduced in Group C at the end of 2-month treatment (p < .05 to p < .001). Total and differential white blood cell (p < .05 to p < .001), as well as serum levels of hs-CRP in Group C were also significantly reduced after 2-month treatment with carvacrol (p < .001). Mean corpuscular hemoglobin concentration and hematocrit were changed in Group C (p < .05 and p < .01, respectively). However, in Group P, there was no significant changes in the evaluated parameters. Pulmonary function tests were increased but respiratory symptoms, inflammatory cells, and hs-CRP were reduced in asthmatic patients who received carvacrol that indicates its therapeutic effect on asthma. [ABSTRACT FROM AUTHOR]
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- 2018
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23. Effect of continuing care for people with cocaine dependence on criminal justice sentences.
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Wimberly, Alexandra S., Hyatt, Jordan M., and McKay, James R.
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SUBSTANCE-induced disorders ,LIFE care communities ,CRIMINAL justice system ,COCAINE ,LOGISTIC regression analysis ,CRIMINAL convictions ,THERAPEUTICS ,SUBSTANCE abuse & psychology ,SUBSTANCE abuse treatment ,COMPARATIVE studies ,CONTINUUM of care ,COUNSELING ,CRIMINOLOGY ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness - Abstract
While continuing care for substance use treatment has been associated with reduced involvement in the criminal justice system, much of this research lacks random assignment to continuing care and so is limited by self-selection bias. This study sought to determine the impact of adding telephone-based continuing care to intensive outpatient programs on criminal justice outcomes for people with cocaine dependence. In three continuing care studies, spanning 1998-2008, participants were randomly assigned to an intensive outpatient program or an intensive outpatient program plus a telephone-based continuing care intervention. Cocaine-dependent participants from these three studies were included in the analyses, with outcomes derived from a dataset of jurisdiction-wide criminal sentences from a state sentencing agency. Multiple logistic regression was employed to examine the odds of a criminal conviction occurring in the 4 years after enrollment in a continuing care study. The results showed that, controlling for a criminal sentence in the previous year, gender, age, and continuing care study, people with cocaine dependence randomized to an intensive outpatient program plus a telephone-based continuing care intervention had 54% lower odds (p = 0.05, odds ratio = 0.46, 95% CI: 0.20-1.02) of a criminal sentence in the 4 years after enrollment in the continuing care study, compared with those randomized to an intensive outpatient program alone. We can conclude that adding telephone monitoring and counseling to intensive outpatient programs is associated with fewer criminal convictions over a 4-year follow-up period compared with intensive outpatient programs alone. [ABSTRACT FROM AUTHOR]
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- 2018
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24. Behavioral Weight Loss Intervention for Migraine: A Randomized Controlled Trial.
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Bond, Dale S., Thomas, J. Graham, Lipton, Richard B., Roth, Julie, Pavlovic, Jelena M., Rathier, Lucille, O'Leary, Kevin C., Evans, E. Whitney, Wing, Rena R., and O'Leary, Kevin C
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MIGRAINE diagnosis ,MIGRAINE ,HEADACHE treatment ,WEIGHT loss ,WOMEN'S health ,MIGRAINE prevention ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS - Abstract
Objective: The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity.Methods: This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI = 25.0-49.9 kg/m2 to 16 weeks of BWL (n = 54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n = 56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models.Results: Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs. + 0.9 [-0.4 to 2.2], P < 0.001) and follow-up (-3.2 [-2.0 to -4.5] vs. + 1.1 [-0.2 to 2.4], P < 0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P = 0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P = 0.378).Conclusions: Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits. [ABSTRACT FROM AUTHOR]- Published
- 2018
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25. Effectiveness of intensive practice nurse counselling versus brief general practitioner advice, both combined with varenicline, for smoking cessation: a randomized pragmatic trial in primary care.
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Rossem, Carolien, Spigt, Mark, Viechtbauer, Wolfgang, Lucas, Annelies E. M., Schayck, Onno C. P., and Kotz, Daniel
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SMOKING cessation ,PRACTICAL nurses ,COUNSELING methodology ,VARENICLINE ,GENERAL practitioners ,CIGARETTE smokers ,PRIMARY care ,HEALTH facilities ,PSYCHOLOGY ,THERAPEUTICS ,TREATMENT effectiveness ,NURSE-patient relationships ,PHYSICIAN-patient relations ,RANDOMIZED controlled trials ,CONFIDENCE intervals ,COUNSELING ,DRUGS ,MEDICAL cooperation ,PATIENT compliance ,PRIMARY health care ,PROBABILITY theory ,RESEARCH ,ODDS ratio - Abstract
Aims To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site ( n = 10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) ( n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% ( n = 48) versus 39.0% [ n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% ( n = 38) versus 28.8% ( n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. [ABSTRACT FROM AUTHOR]
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- 2017
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26. Ultrasound-guided regional blockade for lipoma excision: a new approach to an old technique.
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Tammam, T. F. and Kamhawy, G. A.
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LIPOMA ,DIAGNOSTIC ultrasonic imaging ,ANESTHETICS ,SURGICAL excision ,ANALGESICS ,THERAPEUTICS ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,NERVE block ,RESEARCH ,ULTRASONIC imaging ,EVALUATION research ,RANDOMIZED controlled trials ,SURGERY - Abstract
Background: Local anesthesia for lipoma excision can be feasible with anesthetic injection in the fascial plane between the lipoma and the surrounding soft tissues under real-time ultrasonography [ultrasound- guided lipoma plane (ULP) block]. The advantage of targeting a single anesthetic injection plane under ultrasound guidance may allow for technically easier block placement and long-term analgesic effects.Methods: Forty-eight patients were randomly assigned to receive ULP block, group A (n = 24) or traditional block, group B (n = 24). Primary outcome measure was the number of needle passes required to perform the blockade. The level of procedure pain and the time to first request of analgesia were assessed.Results: Median (interquartile range) needle passes required to complete the blockade was significantly less in the group A 1(1, 1) in comparison with the group B 3 (2.5, 3); P = 0.0001. Group A required fewer needle redirections 1.5 (1, 2) than group B 2 (2, 2.5); P = 0.001. Group A showed significantly less procedure-related pain 2 (2, 3) when compared with group B 4 (3, 4); P = 0.0001. The time to first rescue analgesic was significantly longer in group A (21.3 ± 4.7 h) in comparison with group B (4.4 ± 1.2 h); P = 0.001.Conclusion: Ultrasound-guided lipoma plane blockade reduces the number of needle passes required to complete the block and provides less procedure pain and longer pain relief compared with the traditional block in patients undergoing lipoma excision. [ABSTRACT FROM AUTHOR]- Published
- 2017
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27. A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining.
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Uyl, Tess E., Gladwin, Thomas E., Rinck, Mike, Lindenmeyer, Johannes, Wiers, Reinout W., and den Uyl, Tess E
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ALCOHOLISM risk factors ,PEOPLE with alcoholism ,PSYCHOLOGY of alcoholism ,RANDOMIZED controlled trials ,TRANSCRANIAL magnetic stimulation ,THERAPEUTICS ,MENTAL depression ,ATTITUDE (Psychology) ,ALCOHOLISM treatment ,ALCOHOLISM ,COGNITIVE therapy ,COMBINED modality therapy ,COMPARATIVE studies ,DESIRE ,FRONTAL lobe ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,TREATMENT effectiveness ,BLIND experiment ,TRANSCRANIAL direct current stimulation - Abstract
Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase neuroplasticity and has previously been found to reduce craving. One hundred alcohol-dependent inpatients (91 used for analysis) were randomized into three experimental groups in a double-blind parallel design. The experimental group received four sessions of CBM while receiving 2 mA of anodal tDCS over the dorsolateral prefrontal cortex (DLPFC). There were two control groups: One received sham stimulation during training and one received active stimulation at a different moment. Treatment outcomes were abstinence duration (primary) and relapse after 3 and 12 months, craving and approach bias (secondary). Craving and approach bias scores decreased over time; there were no significant interactions with experimental condition. There was no effect on abstinence duration after three months (χ2(2) = 3.53, p = 0.77). However, a logistic regression on relapse rates after one year (standard outcome in the clinic, but not-preregistered) showed a trend when relevant predictors were included; relapse was lower in the condition receiving active stimulation during CBM only when comparing to sham stimulation (B = 1.52, S.E. = .836, p = .07, without predictors: p = .19). No strong evidence for a specific enhancement effect of tDCS on CBM was found. However, in a post-hoc analysis, tDCS combined with CBM showed a promising trend on treatment outcome. Important limitations are discussed, and replication is necessary to find more reliable effects. [ABSTRACT FROM AUTHOR]
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- 2017
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28. Hesperidin Supplementation Alleviates Oxidative DNA Damage and Lipid Peroxidation in Type 2 Diabetes: A Randomized Double-Blind Placebo-Controlled Clinical Trial.
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Homayouni, Fatemeh, Haidari, Fatemeh, Hedayati, Mehdi, Zakerkish, Mehrnoosh, and Ahmadi, Kambiz
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ANTIOXIDANT analysis ,FLAVANONES ,BLOOD sugar ,COMPARATIVE studies ,DIET ,DIETARY supplements ,DNA ,RESEARCH methodology ,MEDICAL cooperation ,LIPID peroxidation (Biology) ,TYPE 2 diabetes ,RESEARCH ,STATISTICAL sampling ,MALONDIALDEHYDE ,OXIDATIVE stress ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,DEOXYRIBONUCLEOSIDES ,THERAPEUTICS - Abstract
This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty-four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8-hydroxydeoxyguanosine (8-OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0.16 vs. 0.82 ± 0.18), while serum froctoseamin (5.79 ± 5.86 vs. 5.01 ± 4.95; p = 0.001), 8-OHDG (14.32 ± 6.4 vs. 11.00 ± 7.0; p = 0.000), and MDA (5.78 ± 1.76 vs. 4.60 ± 0.75; p = 0.000) decreased in comparison with the baseline values. There was a significant difference in percent change of TAC (13.35 ± 19.21 vs. 3.13 ± 10.02; p = 0.043), froctoseamin (-10.10 ± 16.84 vs. 4.27 ± 34.646), 8-OHDG (-25.11 ± 28.23 vs. 8.69 ± 35.41; p = 0.000), and MDA (-16.46 ± 18.04 vs. -1.82 ± 22.63; p = 0.007) between hesperidin and control groups following intervention in adjusted models. These results suggest that hesperidin may improve TAC and alleviate serum froctoseamin, 8-OHDG, and MDA levels in type 2 diabetes. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]
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29. The impact of telephone-delivered cognitive behaviour therapy and befriending on mood disorders in people with chronic obstructive pulmonary disease: A randomized controlled trial.
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Doyle, Colleen, Bhar, Sunil, Fearn, Marcia, Ames, David, Osborne, Debra, You, Emily, Gorelik, Alex, and Dunt, David
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COGNITIVE therapy ,BEHAVIOR therapy ,SOCIAL control ,MENTAL depression ,ANXIETY ,AFFECTIVE disorders ,COMPARATIVE studies ,OBSTRUCTIVE lung diseases ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,TELEMEDICINE ,TELEPHONES ,SOCIAL support ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DISEASE complications ,PSYCHOLOGICAL factors ,THERAPEUTICS ,PSYCHOLOGY - Abstract
Objectives: The main objectives of this pragmatic randomized controlled trial were to investigate the impact of cognitive behaviour therapy (CBT) and an active social control (befriending) on depression and anxiety symptoms in people with chronic obstructive pulmonary disease (COPD).Methods: Eligible participants were randomly allocated to receive eight weekly telephone interventions of CBT (n = 54) or befriending (n = 56). Repeated-measures ANOVA was used to assess changes in scores and Cohen's d was used to assess effect sizes.Results: Significant improvement was observed in anxiety symptoms for the befriending group from baseline (T1) to post-intervention assessment (T2) and to 8-week follow-up assessment (T3), with a small to medium effect size (Cohen's d = 0.3). Significant improvement was noted in depression symptoms from T1 to T2 for both groups, but only the CBT group had a significant difference at T3, with a small to medium effect size (Cohen's d = 0.4). For secondary outcomes, there was a significant change in COPD symptoms from T1 to T2 for the befriending group; however, at T3 this change was no longer significant. Finally, there was a significant change in general self-efficacy for both groups between T1 and T2, and T1 and T3.Conclusion: Cognitive behaviour therapy reduced depression symptoms but not anxiety. Befriending reduced depression symptoms in the short term and anxiety symptoms in both the short term and long term. Further research is needed to demonstrate non-inferiority of telephone delivery compared with other formats, and to understand the impact of befriending which has the potential to be a cost-effective support for people with COPD. Statement of contribution What is already known on this subject? Depression and anxiety are common comorbidities in people with chronic obstructive pulmonary disease. Mood disorders are not commonly routinely treated in people with chronic obstructive pulmonary disease. Telephone-administered CBT has been shown to be as effective as face-to-face CBT in reducing depression and anxiety. What does this study add? Telephone-administered CBT can reduce depression symptoms in people with COPD. Telephone-administered befriending can reduce anxiety and depression symptoms in people with COPD. People with COPD who have mood disorders would prefer to have CBT than befriending. [ABSTRACT FROM AUTHOR]- Published
- 2017
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30. Big conductance calcium-activated potassium channel openers control spasticity without sedation.
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Baker, David, Pryce, Gareth, Visintin, Cristina, Sisay, Sofia, Bondarenko, Alexander I, Vanessa Ho, W S, Jackson, Samuel J, Williams, Thomas E, Al ‐ Izki, Sarah, Sevastou, Ioanna, Okuyama, Masahiro, Graier, Wolfgang F, Stevenson, Lesley A, Tanner, Carolyn, Ross, Ruth, Pertwee, Roger G, Henstridge, Christopher M, Irving, Andrew J, Schulman, Jesse, and Powell, Keith
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CANNABINOIDS ,MULTIPLE sclerosis ,CANNABIS (Genus) ,ANANDAMIDE ,SPASTICITY ,MESENTERIC artery physiology ,PHARMACOKINETICS ,VAS deferens physiology ,DRUG therapy ,ANIMAL experimentation ,BENZAMIDE ,CELL receptors ,CHEMISTRY ,COMPARATIVE studies ,DEMYELINATION ,DOGS ,DRUGS ,EPITHELIAL cells ,RESEARCH methodology ,MEDICAL cooperation ,MEMBRANE proteins ,MESENTERIC artery ,MICE ,NEUROTRANSMITTERS ,PRIMATES ,RABBITS ,RATS ,RESEARCH ,RESEARCH funding ,VAS deferens ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,PHARMACODYNAMICS ,THERAPEUTICS - Abstract
Background and Purpose: Our initial aim was to generate cannabinoid agents that control spasticity, occurring as a consequence of multiple sclerosis (MS), whilst avoiding the sedative side effects associated with cannabis. VSN16R was synthesized as an anandamide (endocannabinoid) analogue in an anti-metabolite approach to identify drugs that target spasticity.Experimental Approach: Following the initial chemistry, a variety of biochemical, pharmacological and electrophysiological approaches, using isolated cells, tissue-based assays and in vivo animal models, were used to demonstrate the activity, efficacy, pharmacokinetics and mechanism of action of VSN16R. Toxicological and safety studies were performed in animals and humans.Key Results: VSN16R had nanomolar activity in tissue-based, functional assays and dose-dependently inhibited spasticity in a mouse experimental encephalomyelitis model of MS. This effect occurred with over 1000-fold therapeutic window, without affecting normal muscle tone. Efficacy was achieved at plasma levels that are feasible and safe in humans. VSN16R did not bind to known CB1 /CB2 /GPPR55 cannabinoid-related receptors in receptor-based assays but acted on a vascular cannabinoid target. This was identified as the major neuronal form of the big conductance, calcium-activated potassium (BKCa ) channel. Drug-induced opening of neuronal BKCa channels induced membrane hyperpolarization, limiting excessive neural-excitability and controlling spasticity.Conclusions and Implications: We identified the neuronal form of the BKCa channel as the target for VSN16R and demonstrated that its activation alleviates neuronal excitability and spasticity in an experimental model of MS, revealing a novel mechanism to control spasticity. VSN16R is a potential, safe and selective ligand for controlling neural hyper-excitability in spasticity. [ABSTRACT FROM AUTHOR]- Published
- 2017
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31. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine for treatment of malaria infection in pregnancy in Ghana: an open-label, randomised, non-inferiority trial.
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Osarfo, Joseph, Tagbor, Harry, Cairns, Matthew, Alifrangis, Michael, and Magnussen, Pascal
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MALARIA in pregnancy ,AMODIAQUINE ,INFECTION ,VOMITING ,DIZZINESS ,QUINOLINE ,ANTIMALARIALS ,COMMUNICABLE diseases ,COMPARATIVE studies ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,PREGNANCY complications ,RESEARCH ,RESEARCH funding ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,THERAPEUTICS - Abstract
Copyright of Tropical Medicine & International Health is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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32. Cost-effectiveness of extended release naltrexone to prevent relapse among criminal justice-involved individuals with a history of opioid use disorder.
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Murphy, Sean M., Polsky, Daniel, Lee, Joshua D., Friedmann, Peter D., Kinlock, Timothy W., Nunes, Edward V., Bonnie, Richard J., Gordon, Michael, Chen, Donna T., Boney, Tamara Y., and O'Brien, Charles P.
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DRUG abuse treatment ,OPIOID abuse ,MEDICAL care of criminals ,NALTREXONE ,SUBSTANCE abuse relapse ,MEDICAL care costs ,THERAPEUTICS ,CRIMINALS ,CONFIDENCE intervals ,CONTROLLED release preparations ,MEDICAL cooperation ,RESEARCH ,SUBSTANCE abuse ,DISEASE relapse ,RANDOMIZED controlled trials ,QUALITY-adjusted life years - Abstract
Background and Aims Criminal justice-involved individuals are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended-release naltrexone (XR-NTX; Vivitrol
® ) in preventing opioid relapse among criminal justice-involved US adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life and downstream cost-offsets. Our aims were to (1) estimate the incremental cost per quality-adjusted life-year (QALY) gained for XR-NTX versus treatment as usual (TAU) and evaluate it relative to generally accepted value thresholds; and (2) estimate the incremental cost per additional year of opioid abstinence. Design Economic evaluation of the aforementioned trial from the taxpayer perspective. Participants were randomized to 25 weeks of XR-NTX injections or TAU; follow-up occurred at 52 and 78 weeks. Setting Five study sites in the US Northeast corridor. Participants A total of 308 participants were randomized to XR-NTX ( n = 153) or TAU ( n = 155). Measurements Incremental costs relative to incremental economic and clinical effectiveness measures, QALYs and abstinent years, respectively. Findings The 25-week cost per QALY and abstinent-year figures were $162 150 and $46 329, respectively. The 78-week figures were $76 400/QALY and $16 371/abstinent year. At 25 weeks, we can be 10% certain that XR-NTX is cost-effective at a value threshold of $100 000/QALY and 62% certain at $200 000/QALY. At 78 weeks, the cost-effectiveness probabilities are 59% at $100 000/QALY and 76% at $200 000/QALY. We can be 95% confident that the intervention would be considered 'good value' at $90 000/abstinent year at 25 weeks and $500/abstinent year at 78 weeks. Conclusions While extended-release naltrexone appears to be effective in increasing both quality-adjusted life-years (QALYs) and abstinence, it does not appear to be cost-effective using generally accepted value thresholds for QALYs, due to the high price of the injection. [ABSTRACT FROM AUTHOR]- Published
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33. Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial.
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Stark, Dan P., Cook, Adrian, Brown, Julia M., Brundage, Michael D., Embleton, Andrew C., Kaplan, Richard S., Raja, Fharat A., Swart, Ann Marie W., Velikova, Galina, Qian, Wendi, and Ledermann, Jonathan A.
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VASCULAR endothelial growth factor receptors ,OVARIAN cancer ,DISEASE relapse ,CANCER chemotherapy ,QUALITY of life ,ANTINEOPLASTIC agents ,HETEROCYCLIC compounds ,PROTEIN kinase inhibitors ,CANCER relapse ,DRUG therapy ,CLINICAL trials ,COMPARATIVE studies ,EPITHELIAL cell tumors ,RESEARCH methodology ,MEDICAL cooperation ,OVARIAN tumors ,PACLITAXEL ,QUESTIONNAIRES ,RESEARCH ,RESEARCH funding ,EVALUATION research ,RANDOMIZED controlled trials ,DISEASE remission ,BLIND experiment ,CARBOPLATIN ,THERAPEUTICS - Abstract
Background: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.Methods: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.Results: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.Conclusions: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. [ABSTRACT FROM AUTHOR]- Published
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34. Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid.
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Diamond, Ivan R., Grant, Robert C., Pencharz, Paul B., de Silva, Nicole, Feldman, Brian M., Fitzgerald, Peter, Sigalet, David, Dicken, Bryan, Turner, Justine, Marchand, Valerie, Ling, Simon C., Moore, Aideen M., Avitzur, Yaron, and Wales, Paul W.
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INTESTINAL disease treatment ,LIVER disease treatment ,PHOSPHOLIPIDS ,SOY oil ,INTRAVENOUS fat emulsions ,EMULSIONS ,BILIRUBIN ,COMPARATIVE studies ,INTESTINES ,INTESTINAL diseases ,LIVER diseases ,RESEARCH methodology ,MEDICAL cooperation ,PARENTERAL feeding ,RESEARCH ,STATISTICAL sampling ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DISEASE complications ,THERAPEUTICS - Abstract
Background: To examine whether SMOFlipid prevents progression of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent infants with early IFALD (conjugated bilirubin 17-50 µmol/L, 1-3 mg/dL).Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin.Results: Twenty-four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment ( P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, -59 µmol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 µmol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups.Conclusions: Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195. [ABSTRACT FROM AUTHOR]- Published
- 2017
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35. Intravenous midazolam-droperidol combination, droperidol or olanzapine monotherapy for methamphetamine-related acute agitation: subgroup analysis of a randomized controlled trial.
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Yap, Celene Y. L., Taylor, David McD, Knott, Jonathan C., Taylor, Simone E., Phillips, Georgina A., Karro, Jonathan, Chan, Esther W., Kong, David C. M., and Castle, David J.
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METHAMPHETAMINE abuse ,MIDAZOLAM ,DROPERIDOL (Drug) ,OLANZAPINE ,PSYCHOMOTOR disorders ,TREATMENT effectiveness ,THERAPEUTICS ,ANESTHESIA ,DRUG therapy ,COMBINATION drug therapy ,CONFIDENCE intervals ,EMERGENCY medical services ,INTRAVENOUS therapy ,MEDICAL cooperation ,METHAMPHETAMINE ,RESEARCH ,AGITATION (Psychology) ,RANDOMIZED controlled trials ,BLIND experiment ,DESCRIPTIVE statistics ,ODDS ratio - Abstract
Aim To examine the efficacy and safety of (1) midazolam-droperidol versus droperidol and (2) midazolam-droperidol versus olanzapine for methamphetamine-related acute agitation. Design and setting A multi-centre, randomized, double-blind, controlled, clinical trial was conducted in two Australian emergency departments, between October 2014 and September 2015. Participants Three hundred and sixty-one patients, aged 18-65 years, requiring intravenous medication sedation for acute agitation, were enrolled into this study. We report the results of a subgroup of 92 methamphetamine-affected patients. Intervention and comparator Patients were assigned randomly to receive either an intravenous bolus of midazolam 5 mg-droperidol 5 mg combined, droperidol 10 mg or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg or olanzapine 5 mg, respectively. Measurements The primary outcome was the proportion of patients sedated adequately at 10 minutes. Odds ratios with 95% confidence intervals (ORs, 95% CI) were estimated. Findings The baseline characteristics of patients in the three groups were similar. At 10 minutes, significantly more patients in the midazolam-droperidol group [29 of 34 (85.3%)] were sedated adequately compared with the droperidol group [14 of 30 (46.7%), OR = 6.63, 95% CI = 2.02-21.78] or with the olanzapine group [14 of 28 (50.0%), OR 5.80, 95% CI = 1.74-19.33]. The number of patients who experienced an adverse event (AE) in the midazolam-droperidol, droperidol and olanzapine groups was seven of 34, two of 30 and six of 28, respectively. The most common AE was oxygen desaturation. Conclusion A midazolam-droperidol combination appears to provide more rapid sedation of patients with methamphetamine-related acute agitation than droperidol or olanzapine alone. [ABSTRACT FROM AUTHOR]
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36. Seven versus 10 days antibiotic therapy for culture-proven neonatal sepsis: A randomised controlled trial.
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Rohatgi, Smriti, Dewan, Pooja, Faridi, Mohammad Moonis Akbar, Kumar, Ashwani, Malhotra, Rajeev Kumar, and Batra, Prerna
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ANTIBIOTICS ,NEONATAL sepsis ,DRUG efficacy ,PERINATAL care ,HEALTH outcome assessment ,THERAPEUTICS ,COMPARATIVE studies ,DRUG administration ,DOSE-effect relationship in pharmacology ,INTRAVENOUS therapy ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,MICROBIAL sensitivity tests ,RESEARCH ,RISK assessment ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,SEVERITY of illness index ,HOSPITAL mortality - Abstract
Aim: Optimal duration of parenteral antibiotics for treating neonatal sepsis ranges from 7-14 days. We compared the efficacy of 7 versus 10 days duration of intravenous antibiotics for neonatal septicaemia.Methods: We randomised blood culture-proven septic neonates (≥32 weeks and birth weight ≥1.5 kg) to receive either 7 or 10 days duration of intravenous antibiotics. We followed up neonates upto 28 days after stopping antibiotics for treatment failure defined by reappearance of clinical sepsis with a blood culture growing the same organism as cultured earlier, or in the absence of a positive culture, the presence of C-reactive protein and as adjudicated by an expert committee.Results: A total of 132 neonates were randomised to receive either 7 (n = 66) or 10 (n = 66) days duration of antibiotic therapy. Out of 128 neonates (64 per group) followed up, two (one per group) were regarded as 'treatment failure', and two were labelled as fresh episodes of sepsis (both in 10-day group). The risk (95% confidence interval) for treatment failure in the 7-day group was (1.0 (0.064-15.644) was not significantly higher. Neonates in both groups had comparable need for oxygen, inotropic support and blood products, duration of oxygen therapy and time to attainment of full feeds. The duration of hospitalisation was significantly longer in the 10-day group.Conclusion: A 7-day course of intravenous antibiotics may be sufficient to treat neonatal sepsis with the advantage of shorter hospital stay, but a larger meta-analysis would be required to state this with a degree of certainty. [ABSTRACT FROM AUTHOR]- Published
- 2017
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37. Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.
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Smith, Steven R., Garvey, W. Timothy, Greenway, Frank L., Zhou, Sharon, Fain, Randi, Pilson, Robert, Fujioka, Ken, and Aronne, Louis J.
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PHENTERMINE (Drug) ,ANTIOBESITY agents ,REGULATION of body weight ,DRUG tolerance ,DISEASE incidence ,AMPHETAMINES ,COMPARATIVE studies ,HETEROCYCLIC compounds ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,WEIGHT loss ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,PHARMACODYNAMICS ,THERAPEUTICS - Abstract
Objective: To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine.Methods: This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported.Results: N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P < 0.0001 vs. LOR BID) patients.Conclusions: Phentermine added to lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. [ABSTRACT FROM AUTHOR]- Published
- 2017
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38. Development of the Platelet Efficacy Score (PEscore) to predict the efficacy of platelet transfusion in oncohematologic patients.
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Quaglietta, Anna, Saverio, Maura, Lucisano, Giuseppe, Accorsi, Patrizia, and Nicolucci, Antonio
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MEDICAL care ,DISEASES ,COHORT analysis ,LOGISTIC regression analysis ,LYMPHOMAS ,BLOOD platelet transfusion ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RISK assessment ,EVALUATION research ,RANDOMIZED controlled trials ,PREDICTIVE tests ,HEMATOLOGIC malignancies ,THERAPEUTICS - Abstract
Background: Despite the prophylactic use of platelet transfusion, hemorrhagic complications still represent an important cause of morbidity and mortality in patients with hematologic malignancies. Patient-related factors and characteristics of the transfused product can affect transfusion efficacy.Study Design and Methods: The aim of this study was to develop and validate the Platelet Efficacy Score (PEscore), based on patient and product characteristics, to predict the likelihood of a satisfactory platelet transfusion (absolute increment ≥10.5 × 109 /L). This study utilized data relative to 16,265 platelet transfusions performed in 1592 oncohematologic patients. The whole sample was divided into two random samples: a training set, in which different patient-related and transfusion-related characteristics were included in a predictive model to develop the PEscore; and a validation set, in which the predictive properties of the PEscore were confirmed. In the training set, multilevel logistic regression analysis was performed in which the likelihood of attaining a satisfactory transfusion was modeled.Results: The predictive score ranged between 0 and 30. Predictive properties of the PEscore were confirmed by the observed rates of satisfactory transfusions in the validation sample; the probability of a satisfactory transfusion was less than 10% for a score less than 12 and exceeded 50% if the score was 22 or higher. The likelihood of a satisfactory transfusion increased by 29% for a 1-unit increase in the PEscore (odds ratio, 1.29; 95% confidence interval, 1.27-1.31).Conclusion: The availability of a prediction score can increase transfusion efficacy, help the transfusion medicine specialist in the choice of the best product for the individual patient, and avoid waste of resources. [ABSTRACT FROM AUTHOR]- Published
- 2017
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39. Internet-delivered obesity treatment improves symptoms of and risk for depression.
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Naparstek, Jacob, Wing, Rena R., Xu, Xiaomeng, and Leahey, Tricia M.
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MENTAL depression risk factors ,WEIGHT loss ,OBESITY ,METABOLIC disorders ,NUTRITION disorders ,TYPE 2 diabetes ,METABOLIC syndrome ,THERAPEUTICS ,OBESITY & psychology ,OBESITY treatment ,COMPARATIVE studies ,MENTAL depression ,HEALTH promotion ,INTERNET ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,RESIDENTIAL patterns ,SOCIAL support ,EVALUATION research ,LIFESTYLES ,RANDOMIZED controlled trials ,TREATMENT effectiveness - Abstract
Objective: In-person lifestyle interventions for obesity treatment yield significant improvements in depression. These improvements may be attributed to the excellent weight losses produced by in-person interventions. In contrast, Internet programs yield more modest weight losses, and their effect on depression is unknown. This study is the first to examine whether Internet-delivered obesity treatment impacts depressive symptoms.Methods: Participants (N = 136) were randomized to either a community campaign plus Internet behavioral weight loss (IBWL) or community campaign alone (Control). IBWL did not include online social support components. A measure of depressive symptoms was administered, and weight was objectively assessed.Results: Of the total sample, 24% met the clinical cutoff for elevated depression risk at baseline. IBWL participants lost more weight during treatment (P = 0.005) and experienced significantly greater improvements in depressive symptoms (P = 0.02). Among participants who met the clinical cutoff for elevated risk for depression at baseline, those assigned to IBWL had greater improvements in depressive symptoms during treatment compared to Control (P = 0.033). Consequently, at post-treatment, a smaller percentage of IBWL participants were at elevated risk for depression.Conclusions: This study is the first to show that Internet-delivered obesity treatment improves depression risk and depressive symptoms in individuals with overweight or obesity. [ABSTRACT FROM AUTHOR]- Published
- 2017
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40. Oligofructose decreases serum lipopolysaccharide and plasminogen activator inhibitor-1 in adults with overweight/obesity.
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Parnell, Jill A., Klancic, Teja, and Reimer, Raylene A.
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FRUCTOOLIGOSACCHARIDES ,FIBRINOLYTIC agents ,OVERWEIGHT teenagers ,OBESITY risk factors ,LIPOPOLYSACCHARIDE structure ,HEALTH ,OBESITY complications ,BLOOD coagulation factors ,COMPARATIVE studies ,INFLAMMATION ,INFLAMMATORY mediators ,INTERLEUKINS ,OLIGOSACCHARIDES ,RESEARCH methodology ,MEDICAL cooperation ,OBESITY ,RESEARCH ,RESEARCH funding ,TUMOR necrosis factors ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PREBIOTICS ,BLIND experiment ,ADIPONECTIN ,LIPOPOLYSACCHARIDES ,DISEASE complications ,THERAPEUTICS - Abstract
Objective: To determine the effect of prebiotic supplementation on metabolic endotoxemia and systemic inflammation in adults with overweight and obesity.Methods: Samples from a previously conducted randomized, double-blind, placebo-controlled trial were used for analysis. Participants were randomized to 21 g of oligofructose (n = 20; BMI 30.4 kg/m2 ) or a maltodextrin placebo (n = 17; BMI 29.5 kg/m2 ) for 12 weeks. A total of 37 participants had samples available for the current analysis. Resistin, adiponectin, plasminogen activator inhibitor-1 (PAI-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and macrophage chemoattractant protein-1 (MCP-1) were quantified using MILLIPLEX® assays. Lipopolysaccharide (LPS) was measured using PyroGene™ Recombinant Factor C Assay.Results: Plasma LPS concentrations were reduced by 40% in the oligofructose group over 12 weeks compared to a 48% increase in the placebo group (P = 0.04). PAI-1, a risk factor for thrombosis, was reduced to a greater extent in the oligofructose group (-17.3 ± 2.6 ng/ml) compared to the placebo group (-9.7 ± 1.8 ng/ml; P = 0.03). Oligofructose did not affect IL-6, TNF-α, MCP-1, adiponectin, or resistin.Conclusions: Oligofructose reduces metabolic endotoxemia and PAI-1. Incorporating prebiotics into the diet through supplements or functional foods may help mitigate some markers of obesity-associated inflammation. [ABSTRACT FROM AUTHOR]- Published
- 2017
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41. Glass-ceramics bonding in geriatric patients: comparison with young teeth.
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Türk, Ayşe Gözde, Cal, Ebru, Unal, Sena, Güneri, Pelin, Ulusoy, Mübin, Ozden, Meltem, Türk, Ayşe Gözde, Güneri, Pelin, and Ulusoy, Mübin
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DENTAL bonding ,GERIATRIC dentistry ,GLASS-ceramics ,DENTAL adhesives ,DENTAL cements ,OLDER patients ,THERAPEUTIC use of biomedical materials ,AGE distribution ,BIOMECHANICS ,COMPARATIVE studies ,DENTAL veneers ,DENTISTRY ,RESEARCH methodology ,MEDICAL cooperation ,MOLARS ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,SURFACE properties ,THERAPEUTICS - Abstract
Objective: The aim of the study was to assess whether in geriatric patients, the shear bond strength (SBS) of glass-ceramics differed when compared to young controls.Background: In the need of aesthetic restorations for geriatric patients, reliable bonding of glass-ceramics should be accomplished; however, glass-ceramics bonding on aged tooth structures is still unclear.Materials and Methods: Sixty extracted molars from young and geriatric patients [18-25 (Y), and 65-80 (O)] were cut buccolingually to prepare enamel (E) and dentin (D) surfaces. Both surfaces were randomly divided into three groups according to the resin cements: Variolink II (V); Superbond (S); and Clearfil Esthetic Cement (C) (n = 10). Disc-shaped glass-ceramics (IPS E-max Press) (n = 120) were prepared. Specimens were bonded and subjected to thermocycling. SBS test was performed using a universal testing machine (0.5 mm/min). After debonding, the surfaces were examined using stereomicroscope and scanning electron microscope. Data were statistically analysed with Kolmogorov-Smirnov, Levene, anova and Bonferroni tests (p = 0.05).Results: There were no significant differences between the old and young teeth surfaces. V showed the highest SBS [MPa(SD)] on both enamel and dentin [36.7 (6.5) (YE), 23.2 (13.2) (YD), 32.1 (16.2) (OE), 25.5 (8.6) (OD), respectively]. Significant differences were observed between resin cements (p < 0.05). The failure types were 43% adhesive between tooth and cement, 48% mix, 9% adhesive between cement and ceramic, regardless of cement type.Conclusion: In geriatric patients, the shear bond strength of glass-ceramics did not differ when compared to that of young controls. On the dentin surface, etch-rinse resin cements appear to be more appropriate for glass-ceramics bonding. [ABSTRACT FROM AUTHOR]- Published
- 2017
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42. Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial.
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Alberico, S, Erenbourg, A, Hod, M, Yogev, Y, Hadar, E, Neri, F, Ronfani, L, Maso, G, and GINEXMAL Group
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GESTATIONAL diabetes ,PREGNANCY complications ,DELIVERY (Obstetrics) ,MATERNAL mortality ,CESAREAN section ,COMPARATIVE studies ,INFANT mortality ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,DURATION of pregnancy ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS - Abstract
Objective: To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term.Design: Multicentre open-label randomised controlled trial.Setting: Eight teaching hospitals in Italy, Slovenia, and Israel.Sample: Singleton pregnancy, diagnosed with gestational diabetes by the International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC), between 38+0 and 39+0 weeks of gestation, without other maternal or fetal conditions.Methods: Patients were randomly assigned to induction of labour or expectant management and intensive follow-up. Data were analysed by 'intention to treat'.Main Outcome Measures: The primary outcome was incidence of caesarean section. Secondary outcomes were maternal and perinatal mortality and morbidity.Results: A total of 425 women were randomised to the study groups. The incidence of caesarean section was 12.6% in the induction group versus 11.7% in the expectant group. No difference was found between the two groups (relative risk, RR 1.06; 95% confidence interval, 95% CI 0.64-1.77; P = 0.81). The incidence of non-spontaneous delivery, either by caesarean section or by operative vaginal delivery, was 21.0 and 22.3%, respectively (RR 0.94; 95% CI 0.66-1.36; P = 0.76). Neither maternal nor fetal deaths occurred. The few cases of shoulder dystocia were solved without any significant birth trauma.Conclusions: In women with gestational diabetes, without other maternal or fetal conditions, no difference was detected in birth outcomes regardless of the approach used (i.e. active versus expectant management). Although the study was underpowered, the magnitude of the between-group difference was very small and without clinical relevance.Tweetable Abstract: Immediate delivery or expectant management in gestational diabetes at term? [ABSTRACT FROM AUTHOR]- Published
- 2017
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43. Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial.
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Johannessen, HH, Wibe, A, Stordahl, A, Sandvik, L, Mørkved, S, Johannessen, H H, and Mørkved, S
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FECAL incontinence ,PELVIC floor ,DEFECATION disorders ,PHYSIOLOGICAL therapeutics ,ULTRASONIC imaging ,TREATMENT of fecal incontinence ,LABOR complications (Obstetrics) ,ANUS ,COMPARATIVE studies ,DELIVERY (Obstetrics) ,EXERCISE therapy ,MANOMETERS ,RESEARCH methodology ,MEDICAL cooperation ,MUSCLES ,PUERPERIUM ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,SEVERITY of illness index ,THERAPEUTICS ,WOUNDS & injuries - Abstract
Objective: To evaluate the effect of pelvic floor muscle exercises (PFME) for postpartum anal incontinence (AI).Design: A parallel two-armed randomised controlled trial stratified on obstetrical anal sphincter injury with primary sphincter repair and hospital affinity.Setting: Ano-rectal specialist out-patient clinics at two hospitals in Norway.Population: One hundred and nine postpartum women with AI at baseline.Methods: The intervention group received 6 months of individual physiotherapy-led PFME and the control group written information on PFME. Changes in St. Mark's scores and predictors of post-intervention AI were assessed by independent samples t-tests and multiple linear regression analyses, respectively. The study was not blind.Main Outcome Measures: The primary outcome measure was change in AI symptoms on the St. Mark's score from baseline to post-intervention. Secondary outcome measures were manometry measures of anal sphincter length and strength, endoanal ultrasound (EAUS) defect score and voluntary pelvic floor muscle contraction.Results: There was a significant difference in the reduction of St. Mark's scores from baseline to post-intervention in favour of the PFME group (-2.1 versus -0.8 points, P = 0.040). No differences in secondary outcome measures were found between groups. Baseline St. Mark's, PFME group affinity and EAUS defect score predicted post-intervention St. Mark's score in the imputed intention-to-treat analyses. The analysis on un-imputed data showed that women performing weekly PFME improved their AI scores more than women in the control group did.Conclusions: Our results indicate that individually adapted PFME reduces postpartum AI symptoms.Tweetable Abstract: Performing regular pelvic floor muscle exercises may be an effective treatment for postpartum anal incontinence. [ABSTRACT FROM AUTHOR]- Published
- 2017
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44. An randomized controlled trial of Post-it® notes did not increase postal response rates in older depressed participants.
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Lewis, Helen, Keding, Ada, Bosanquet, Katharine, Gilbody, Simon, and Torgerson, David
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HEALTH care reminder systems ,THERAPEUTICS ,MENTAL depression ,GERIATRIC assessment ,CONFIDENCE intervals ,MEDICAL cooperation ,QUESTIONNAIRES ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,HEALTH self-care ,TIME ,LOGISTIC regression analysis ,STATISTICAL power analysis ,RANDOMIZED controlled trials ,HUMAN research subjects ,PROPORTIONAL hazards models ,DATA analysis software ,KAPLAN-Meier estimator ,ODDS ratio ,OLD age - Abstract
Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER
+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]- Published
- 2017
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45. The Impact of Resveratrol Supplementation on Blood Glucose, Insulin, Insulin Resistance, Triglyceride, and Periodontal Markers in Type 2 Diabetic Patients with Chronic Periodontitis.
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Zare Javid, Ahmad, Hormoznejad, Razie, Yousefimanesh, Hojat allah, Zakerkish, Mehrnoosh, Haghighi ‐ zadeh, Mohammad Hosein, Dehghan, Parvin, and Ravanbakhsh, Maryam
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BLOOD sugar ,CHRONIC diseases ,COMPARATIVE studies ,INSULIN ,INSULIN resistance ,RESEARCH methodology ,MEDICAL cooperation ,PERIODONTITIS ,RESEARCH ,STILBENE ,TRIGLYCERIDES ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,IMPACT of Event Scale ,THERAPEUTICS - Abstract
The aim of this study was to investigate the impact of resveratrol supplementation along with non-surgical periodontal treatment on blood glucose, insulin, insulin resistance, triglyceride (TG), and periodontal markers in patients with type 2 diabetes with periodontal disease. In this double-blind clinical trial study, 43 patients with diabetes with chronic periodontitis were participated. Subjects were randomly allocated to intervention and control groups. The intervention and control groups received either 480 mg/day of resveratrol or placebo capsules (two pills) for 4 weeks. Fasting blood glucose, insulin, insulin resistance (homeostasis model assessment of insulin resistance), TGs, and pocket depth were measured in all subjects' pre-intervention and post-intervention. The mean serum levels of fasting insulin and insulin resistance (homeostasis model assessment of insulin resistance) were significantly lower in the intervention group compared with control group (10.42 ± 0.28 and 10.92 ± 0.9; 3.66 ± 0.97 and 4.49 ± 1.56, respectively). There was a significant difference in the mean pocket depth between intervention and control groups (2.35 ± 0.6 and 3.38 ± 0.5, respectively) following intervention. No significant differences were observed in the mean levels of fasting blood glucose and TGs between two groups' post-intervention. It is recommended that resveratrol supplementation may be beneficial as adjuvant therapy along with non-surgical periodontal treatment in insulin resistance and improving periodontal status among patients with diabetes with periodontal disease. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]
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- 2017
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46. A health advocacy intervention for adolescents with intellectual disability: a cluster randomized controlled trial.
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Lennox, Nicholas, McPherson, Lyn, Bain, Chris, O'Callaghan, Michael, Carrington, Suzanne, and Ware, Robert S
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INTELLECTUAL disabilities ,HEALTH education ,HEALTH promotion ,MENTAL health of teenagers ,RANDOMIZED controlled trials ,THERAPEUTICS ,COMPARATIVE studies ,HEALTH status indicators ,RESEARCH methodology ,MEDICAL cooperation ,PEOPLE with intellectual disabilities ,HEALTH outcome assessment ,PAMPHLETS ,POCKET computers ,PREVENTIVE health services ,RESEARCH ,SCHOOL health services ,EVALUATION research - Abstract
Aim: Adolescents with intellectual disability experience poorer heath than their peers in the general population, partially due to communication barriers and knowledge gaps in their health history. This study aimed to test a health intervention package against usual care for a range of health promotion and disease detection outcomes.Method: A parallel-group cluster randomized controlled trial was conducted with Australian adolescents with intellectual disability living in the community. Randomization occurred at school level. The intervention package consisted of classroom-based health education, a hand-held personalized health record, and a health check. Evidence of health promotion, disease prevention, and case-finding activities were extracted from general practitioners' records for 12 months post-intervention.Results: Clinical data was available for 435 of 592 (73.5%) participants from 85 schools. Adolescents allocated to receive the health intervention were more likely to have their vision (odds ratio [OR] 3.3; 95% confidence interval [CI] 1.8-6.1) and hearing (OR 2.7; 95% CI 1.0-7.3) tested, their blood pressure checked (OR 2.4; 95% CI 1.6-3.7), and weight recorded (OR 4.8; 95% CI 3.1-7.6). There was no difference between health intervention and usual care for identification of new diseases.Interpretation: The school-based intervention package increased healthcare activity in adolescents with intellectual disability living in the community. [ABSTRACT FROM AUTHOR]- Published
- 2016
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47. Triphala, a New Herbal Mouthwash for the Treatment of Gingivitis: A Randomized Controlled Clinical Trial.
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Pradeep, A.R., Suke, Deepak Kumar, Martande, Santosh S., Singh, Sonender Pal, Nagpal, Kanika, and Naik, Savitha B.
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MOUTHWASHES ,GINGIVITIS ,HERBAL medicine ,DENTAL plaque ,PLACEBOS ,CHLORHEXIDINE ,ORAL microbiology ,FOLLOW-up studies (Medicine) ,THERAPEUTICS ,PREVENTION ,THERAPEUTIC use of plant extracts ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,PERIODONTICS ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials - Abstract
Background: An antiplaque agent with minimal side effects that can be used as an effective adjunct to mechanical plaque control is needed. The current study is designed to evaluate efficacy of triphala (TRP) mouthwash in reduction of plaque and gingivitis.Methods: Ninety individuals with chronic generalized gingivitis were randomly assigned to three groups: 1) group I, placebo mouthwash; 2) group II, TRP mouthwash; and 3) group III, chlorhexidine (CHX) mouthwash. All individuals were instructed to rinse with their respective mouthwash twice daily. 1) Plaque index (PI); 2) gingival index (GI); 3) oral hygiene index-simplified (OHI-S); and 4) microbiologic colony counts were recorded at baseline and at 7, 30, and 60 days.Results: All three groups showed gradual reduction in PI, GI, and OHI-S levels from baseline to 7, 30, and 60 days. There was also significant reduction in microbial counts in all groups at all time intervals except in group I. A significant difference was noticed with respect to reduction in PI, GI, OHI-S, and microbiologic counts in group I compared with groups II and III. However, no significant differences were found between groups II and III for any parameters at any time intervals.Conclusions: TRP mouthwash was found to decrease inflammatory parameters from baseline to follow-up intervals. Because improvement in gingivitis was comparable with that of CHX mouthwash, TRP mouthwash can be considered a potential therapeutic agent in the treatment of gingivitis. [ABSTRACT FROM AUTHOR]- Published
- 2016
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48. Local Minocycline Effect on Inflammation and Clinical Attachment During Periodontal Maintenance: Randomized Clinical Trial.
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Killeen, Amy C., Harn, Jennifer A., Erickson, Leah M., Yu, Fang, and Reinhardt, Richard A.
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PERIODONTICS ,MINOCYCLINE ,INFLAMMATION ,PERIODONTAL pockets ,DENTAL scaling ,TOOTH root planing ,PERIODONTAL probe ,INTERLEUKIN-1 ,ANTIBIOTICS ,COMPARATIVE studies ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,PERIODONTAL disease ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS - Abstract
Background: Minocycline microspheres (MMs) are being used to treat residual inflamed periodontal pockets during periodontal maintenance therapy (PMT), but evidence for efficacy from randomized clinical trials is lacking. The purpose of this study is to evaluate the effect of MMs plus scaling and root planing (SRP) on these sites.Methods: Sixty patients with chronic periodontitis on 6-month PMT intervals to be followed for 1 year were randomized (51 completed the study) into two statistically similar groups, SRP + MM (aged 66.8 years) and SRP alone (aged 67 years), to treat a ≥5 mm posterior interproximal pocket during PMT with a history of bleeding on probing (BOP). Group treatments were applied to the site at baseline and 6 months. Clinical attachment levels (CALs; primary outcome), probing depths (PDs), plaque, and BOP also were recorded at baseline and 6 and 12 months. In addition, gingival crevicular fluid was analyzed for an inflammation index ratio of interleukin (IL)-1β/IL-1 receptor antagonist (ra) using enzyme-linked immunosorbent assays.Results: All clinical parameters improved significantly (P <0.005) from baseline in both groups with no differences between groups at any time point. CAL decreased 17% (0.9 ± 0.8 mm) and 13% (0.7 ± 0.9 mm) in SRP + MM and 11% (0.7 ± 1.1 mm) and 21% (1.2 ± 0.9 mm) in SRP at 6 and 12 months, respectively. The odds of having BOP decreased 90% (down to 38% of patients) and 95% (26%) in SRP + MM and 82% (42%) and 82% (41%) in SRP at 6 and 12 months, respectively. IL-1β/IL-1ra decreased a significant 61% (P = 0.009) only in SRP + MM at 6 months.Conclusions: SRP of inflamed moderate pockets during 6-month PMT, with or without MMs, improves CALs, along with PDs and BOP over a 1-year period. The use of MMs did not result in an additional benefit over SRP alone. [ABSTRACT FROM AUTHOR]- Published
- 2016
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49. Efficacy of a Nasal Spray from Citrus limon and Cydonia oblonga for the Treatment of Hay Fever Symptoms-A Randomized, Placebo Controlled Cross-Over Study.
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Hoffmann, A., Klein, S. D., Gründemann, C., Garcia ‐ Käufer, M., Wolf, U., and Huber, R.
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ANTIHISTAMINES ,INTRANASAL medication ,AEROSOLS ,CITRUS ,COMPARATIVE studies ,CROSSOVER trials ,SEASONAL variations of diseases ,ALLERGIC rhinitis ,RESEARCH methodology ,MEDICAL cooperation ,PLANTS ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS - Abstract
Nasal spray from lemon and quince (LQNS) is used to treat hay fever symptoms and has been shown to inhibit histamine release from mast cells in vitro. Forty-three patients with grass pollen allergy (GPA) were randomized to be treated either with placebo or LQNS for one week, respectively, in a cross-over study. At baseline and after the respective treatments patients were provoked with grass pollen allergen. Outcome parameters were nasal flow measured with rhinomanometry (primary), a nasal symptom score, histamine in the nasal mucus and tolerability. In the per protocol population absolute inspiratory nasal flow 10 and 20 min after provocation was higher with LQNS compared to placebo (-37 ± 87 mL/s; p = 0.027 and -44 ± 85 mL/s; p = 0.022). The nasal symptom score showed a trend (3.3 ± 1.8 in the placebo and 2.8 ± 1.5 in the LQNS group; p = 0.070) in favor of LQNS; the histamine concentration was not significantly different between the groups. Tolerability of both, LQNS and placebo, was rated as very good. LQNS seems to have an anti-allergic effect in patients with GPA. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]
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- 2016
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50. Efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation and heart failure: insights from ENGAGE AF-TIMI 48.
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Magnani, Giulia, Giugliano, Robert P., Ruff, Christian T., Murphy, Sabina A., Nordio, Francesco, Metra, Marco, Moccetti, Tiziano, Mitrovic, Veselin, Shi, Minggao, Mercuri, Michele, Antman, Elliott M., and Braunwald, Eugene
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THIAZOLES ,WARFARIN ,DRUG therapy ,HEART failure treatment ,ATRIAL fibrillation treatment ,VITAMIN K ,DRUG efficacy ,MEDICATION safety ,THERAPEUTICS ,VITAMIN therapy ,ANTICOAGULANTS ,PYRIDINE ,STROKE prevention ,ATRIAL fibrillation ,COMPARATIVE studies ,HEART failure ,HEMORRHAGE ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,STATISTICAL sampling ,STROKE ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PROPORTIONAL hazards models ,BLIND experiment ,DISEASE complications - Abstract
Aims: In the ENGAGE AF-TIMI 48 trial, edoxaban, a factor Xa inhibitor, was not found to be inferior to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with atrial fibrillation (AF) and was associated with significantly less bleeding. The higher-dose edoxaban regimen (HDER; 60 mg dose-reduced to 30 mg once daily) has been approved in various countries in Europe, the USA, and Japan. Among patients treated with vitamin K antagonists (VKAs), symptomatic heart failure (HF) is an independent risk factor for lower time-in-therapeutic range, which reduces the efficacy and safety of VKA therapy. We evaluated the efficacy and safety of edoxaban compared with warfarin across the spectrum of HF severity in the ENGAGE AF-TIMI 48 trial.Methods and Results: Of 14 071 patients randomized to well-controlled warfarin or the HDER, 5926 (42%) had no history of HF, 6344 (45%) were in New York Heart Association (NYHA) class I-II, and 1801 (13%) were in NYHA class III-IV. The efficacy of edoxaban compared with warfarin in preventing stroke/SEE was similar in patients without and with HF regardless of the severity of HF; [HDER vs. warfarin: No-HF: hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.69-1.11; NYHA class I-II: HR 0.88, 95% CI 0.69-1.12; NYHA class III-IV: HR 0.83, 95% CI 0.55-1.25; Pinteraction = 0.97]. Compared with warfarin, HDER was consistently associated with lower risk of major bleeding (No-HF: HR 0.82, 95% CI 0.68-0.99; NYHA class I-II: HR 0.79, 95% CI 0.65-0.96; NYHA class III-IV: HR 0.79, 95% CI 0.54-1.17; Pinteraction = 0.96).Conclusion: The relative efficacy and safety of HDER compared with well-managed warfarin in AF patients with HF were similar to those without HF. [ABSTRACT FROM AUTHOR]- Published
- 2016
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