16 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. 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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4. 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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5. 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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6. 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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7. 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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- 2017
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8. 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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9. 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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10. 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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11. 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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12. Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy.
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Hesketh, Paul J., Schnadig, Ian D., Schwartzberg, Lee S., Modiano, Manuel R., Jordan, Karin, Arora, Sujata, Powers, Dan, and Aapro, Matti
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SUBSTANCE P receptors ,CARBOPLATIN ,CANCER chemotherapy ,CANCER treatment ,TACHYKININ receptors ,CYCLOPHOSPHAMIDE ,IMMUNOSUPPRESSIVE agents ,VOMITING prevention ,ANTINEOPLASTIC agents ,CHEMOPREVENTION ,COMPARATIVE studies ,RESEARCH methodology ,HYDROCARBONS ,MEDICAL cooperation ,NAUSEA ,NEUROTRANSMITTER receptors ,RESEARCH ,STATISTICAL sampling ,TUMORS ,VOMITING ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,CHEMICAL inhibitors ,DISEASE complications ,PREVENTION ,THERAPEUTICS - Abstract
Background: Rolapitant, a novel neurokinin-1 receptor antagonist, provided effective protection against chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase 3 trial of patients receiving moderately emetogenic chemotherapy or an anthracycline and cyclophosphamide regimen. The current analysis explored the efficacy and safety of rolapitant in preventing CINV in a subgroup of patients receiving carboplatin.Methods: Patients were randomized 1:1 to receive oral rolapitant (180 mg) or a placebo 1 to 2 hours before chemotherapy administration; all patients received oral granisetron (2 mg) on days 1 to 3 and oral dexamethasone (20 mg) on day 1. A post hoc analysis examined the subgroup of patients receiving carboplatin in cycle 1. The efficacy endpoints were as follows: complete response (CR), no emesis, no nausea, no significant nausea, complete protection, time to first emesis or use of rescue medication, and no impact on daily life.Results: In the subgroup administered carboplatin-based chemotherapy (n = 401), a significantly higher proportion of patients in the rolapitant group versus the control group achieved a CR in the overall phase (0-120 hours; 80.2% vs 64.6%; P < .001) and in the delayed phase (>24-120 hours; 82.3% vs 65.6%; P < .001) after chemotherapy administration. Superior responses were also observed by the measures of no emesis, no nausea, and complete protection in the overall and delayed phases and by the time to first emesis or use of rescue medication. The incidence of treatment-emergent adverse events was similar for the rolapitant and control groups.Conclusions: Rolapitant provided superior CINV protection to patients receiving carboplatin-based chemotherapy in comparison with the control. These results support rolapitant use as part of the antiemetic regimen in carboplatin-treated patients. Cancer 2016;122:2418-2425. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]- Published
- 2016
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13. Effectiveness of an alcohol-free essential oil-containing mouthwash in institutionalised elders receiving long-term care: a feasibility study.
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Chalhoub, Elsy, Emami, Elham, Freijé, Maria, Kandelman, Daniel, Campese, Melanie, St‐Georges, Annie, Voyer, René, Rompré, Pierre, Barbeau, Jean, Leduc, Annie, and Durand, Robert
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MOUTHWASHES ,ANTISEPTICS in dentistry ,ORAL hygiene products ,LONG-term health care ,MEDICAL care ,SICK people ,BACTERIA classification ,THERAPEUTIC use of essential oils ,SALIVA microbiology ,BACTERICIDES ,BACTERIA ,CANDIDA ,COMPARATIVE studies ,DEMOGRAPHY ,DENTAL plaque ,DENTIFRICES ,DENTURES ,ETHANOL ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL records ,RESEARCH ,STATISTICAL sampling ,TOOTH care & hygiene ,TOBACCO ,WATER ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS ,PREVENTION - Abstract
Objectives: To conduct a feasibility study on investigating the effectiveness of an alcohol-free essential oil mouthwash (AF-EOMW) to reduce plaque accumulation and oral pathogen levels in institutionalised elders receiving long-term care and to obtain preliminary results.Background: Although simple, cost-effective strategies to improve oral hygiene in seniors such as the use of mouthwashes have been shown to reduce the risks of respiratory diseases, little information is available on the feasibility of implementing these measures.Methods: Twenty-five elderly participants with significant loss of autonomy were initially recruited and divided into two groups. A test group rinsed with an AF-EOMW twice a day, and a control group rinsed with tap water. Data on demographic characteristics, dental history and tobacco use were collected from a questionnaire. Problems encountered during recruitment and data collection were documented. Plaque index, denture cleanliness and salivary levels of several pathogens were measured at three time points: baseline (T0 ), day 22 (T1 ) and day 45 (T2 ).Results: Eighteen participants completed the study. Several problems were encountered during recruitment and execution of the study protocol. No significant differences in clinical or microbiological measures were found between the test group and controls at three time points (p > 0.05).Conclusion: This pilot study shows that, if sufficient logistical and financial resources are available, it is feasible to conduct randomised clinical trials in a seniors' facility. The use of an AF-EOMW to improve oral hygiene in seniors was not found to be superior to tap water. However, larger controlled clinical studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]- Published
- 2016
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14. Clinical and Microbiologic Evaluation of Scaling and Root Planing per Quadrant and One-Stage Full-Mouth Disinfection Associated With Azithromycin or Chlorhexidine: A Clinical Randomized Controlled Trial.
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Fonseca, Douglas Campideli, Cortelli, José Roberto, Cortelli, Sheila Cavalca, Miranda Cota, Luís Otávio, Machado Costa, Lidiane Cristina, Moreira Castro, Marcos Vinicius, Oliveira Azevedo, Andréa Mara, and Costa, Fernando Oliveira
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DENTAL scaling ,TOOTH root planing ,AZITHROMYCIN ,CHLORHEXIDINE ,RANDOMIZED controlled trials ,PERIODONTITIS ,POLYMERASE chain reaction ,PERIODONTAL probe ,BACTERICIDES ,COMPARATIVE studies ,GRAM-negative bacteria ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,PERIODONTAL pockets ,PERIODONTICS ,RESEARCH ,STATISTICAL sampling ,STERILIZATION (Disinfection) ,EVALUATION research ,THERAPEUTICS - Abstract
Background: Conflicting data about the protocol of choice for non-surgical periodontal therapy with adjuvant use are still reported. This study aims to evaluate, through clinical and microbiologic parameters, the systemic use of azithromycin (AZ) and chlorhexidine (CHX) as adjuvants to non-surgical periodontal treatment performed by one-stage full-mouth disinfection (FMD) within 24 hours or conventional quadrant scaling (QS) in four weekly sections.Methods: In this randomized controlled trial, 85 patients diagnosed with chronic periodontitis underwent different treatment protocols, in six groups: three FMD groups and three QS groups, each with no adjuvants, with CHX, and with AZ. Clinical periodontal parameters were recorded, and total and quantitative bacterial counts of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, and Streptococcus oralis were measured with real-time polymerase chain reaction at baseline and 90 and 180 days after treatment.Results: In all groups, a significant reduction was observed in the percentage of periodontal diseased sites, gingival index, plaque index, and clinical attachment level gain at 90 days, demonstrating effectiveness of the treatment, independently of the adjuvant. The FMD with CHX group showed higher reduction in probing depth and percentage of periodontal diseases sites, as well as lower total bacterial count, than all the other groups at 180 days.Conclusions: The adjuvant use of AZ did not provide any significant benefit, independently of the treatment protocol. The adjuvant use of CHX showed a more expressive and significant improvement in clinical and microbiologic parameters, especially in the FMD protocol, followed by QS. [ABSTRACT FROM AUTHOR]- Published
- 2015
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15. Maintenance of serum potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a phase 3 randomized, double-blind, placebo-controlled trial.
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Anker, Stefan D., Kosiborod, Mikhail, Zannad, Faiez, Piña, Ileana L., McCullough, Peter A., Filippatos, Gerasimos, van der Meer, Peter, Ponikowski, Piotr, Rasmussen, Henrik S., Lavin, Philip T., Singh, Bhupinder, Yang, Alex, and Deedwania, Prakash
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HEART failure patients ,CARDIOTONIC agents ,PHYSIOLOGICAL effects of potassium ,ZIRCONIUM compounds ,CYCLOSILICATES ,PHYSIOLOGICAL effects of sodium ,PLACEBOS ,RANDOMIZED controlled trials ,THERAPEUTICS ,SILICATES ,COMPARATIVE studies ,HEART failure ,RESEARCH methodology ,MEDICAL cooperation ,POTASSIUM ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,BLIND experiment ,HYPERKALEMIA - Abstract
Aims: Hyperkalaemia in heart failure patients limits use of cardioprotective renin-angiotensin-aldosterone system inhibitors (RAASi). Sodium zirconium cyclosilicate (ZS-9) is a selective potassium ion trap, whose mechanism of action may allow for potassium binding in the upper gastrointestinal tract as early as the duodenum following oral administration. ZS-9 previously demonstrated the ability to reduce elevated potassium levels into the normal range, with a median time of normalization of 2.2 h and sustain normal potassium levels for 28 days in HARMONIZE--a Phase 3, double-blind, randomized, placebo-controlled trial. In the present study we evaluated management of serum potassium with daily ZS-9 over 28 days in heart failure patients from HARMONIZE, including those receiving RAASi therapies.Methods and Results: Heart failure patients with evidence of hyperkalaemia (serum potassium ≥5.1 mmol/L, n = 94) were treated with open-label ZS-9 for 48 h. Patients (n = 87; 60 receiving RAASi) who achieved normokalaemia (potassium 3.5-5.0 mmol/L) were randomized to daily ZS-9 (5, 10, or 15 g) or placebo for 28 days. Mean potassium and proportion of patients maintaining normokalaemia during days 8-29 post-randomization were evaluated. Despite RAASi doses being kept constant, patients on 5 g, 10 g, and 15 g ZS-9 maintained a lower potassium level (4.7 mmol/L, 4.5 mmol/L, and 4.4 mmol/L, respectively) than the placebo group (5.2 mmol/L; P<0.01 vs. each ZS-9 group); greater proportions of ZS-9 patients (83%, 89%, and 92%, respectively) maintained normokalaemia than placebo (40%; P < 0.01 vs. each ZS-9 group). The safety profile was consistent with previously reported overall study population.Conclusion: Compared with placebo, all three ZS-9 doses lowered potassium and effectively maintained normokalaemia for 28 days in heart failure patients without adjusting concomitant RAASi, while maintaining a safety profile consistent with the overall study population. [ABSTRACT FROM AUTHOR]- Published
- 2015
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16. Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets During Maintenance Therapy Using Diode Laser: A Randomized Clinical Trial.
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Nguyen, Naomi‐Trang, Byarlay, Matthew R., Reinhardt, Richard A., Marx, David B., Meinberg, Trudy A., and Kaldahl, Wayne B.
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PERIODONTAL disease prevention ,LASER therapy ,COMBINED modality therapy ,COMPARATIVE studies ,DENTAL scaling ,EXUDATES & transudates ,INTERLEUKIN-1 ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,PERIODONTAL disease ,PERIODONTAL pockets ,PERIODONTITIS ,RESEARCH ,STATISTICAL sampling ,TOOTH root planing ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,PREVENTION - Abstract
Background: Numerous studies have documented the clinical outcomes of laser therapy for untreated periodontitis, but very few have reported on lasers treating inflamed pockets during maintenance therapy. The aim of this study is to compare the effectiveness of scaling and root planing (SRP) plus the adjunctive use of diode laser therapy to SRP alone on changes in the clinical parameters of disease and on the gingival crevicular fluid (GCF) inflammatory mediator interleukin-1β (IL-1β) in patients receiving regular periodontal maintenance therapy.Methods: This single-masked and randomized, controlled, prospective study includes 22 patients receiving regular periodontal maintenance therapy who had one or more periodontal sites with a probing depth (PD) ≥ 5 mm with bleeding on probing (BOP). Fifty-six sites were treated with SRP and adjunctive laser therapy (SRP + L). Fifty-eight sites were treated with SRP alone. Clinical parameters, including PD, clinical attachment level (CAL), and BOP, and GCF IL-1β levels were measured immediately before treatment (baseline) and 3 months after treatment.Results: Sites treated with SRP + L and SRP alone resulted in statistically significant reductions in PD and BOP and gains in CAL. These changes were not significantly different between the two therapies. Similarly, differences in GCF IL-1β levels between SRP + L and SRP alone were not statistically significant.Conclusion: In periodontal maintenance patients, SRP + L did not enhance clinical outcomes compared to SRP alone in the treatment of inflamed sites with ≥ 5 mm PD. [ABSTRACT FROM AUTHOR]- Published
- 2015
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