9 results
Search Results
2. Nutritional intervention and neurodevelopmental outcome in infants with suspected cerebral palsy: the Dolphin infant double-blind randomized controlled trial.
- Author
-
Andrew, Morag J., Montague‐Johnson, Christine, Laler, Karen, Baker, Bonny, Sullivan, Peter B., Parr, Jeremy R., Qi, Cathy, and Montague-Johnson, Christine
- Subjects
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.)
- Published
- 2018
- Full Text
- View/download PDF
3. Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis-Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and II.
- Author
-
Volkmann, Elizabeth R., Tashkin, Donald P., Li, Ning, Roth, Michael D., Khanna, Dinesh, Hoffmann‐Vold, Anna‐Maria, Kim, Grace, Goldin, Jonathan, Clements, Philip J., Furst, Daniel E., and Elashoff, Robert M.
- Subjects
DIAGNOSIS of dyspnea ,CYCLOPHOSPHAMIDE ,MYCOPHENOLIC acid ,TREATMENT effectiveness ,CLINICAL trials ,INTERSTITIAL lung diseases ,LONGITUDINAL method ,PROBABILITY theory ,RESPIRATORY measurements ,STATISTICAL sampling ,SYSTEMIC scleroderma ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,DISEASE complications ,THERAPEUTICS - Abstract
Objective To compare mycophenolate mofetil (MMF) with placebo for the treatment of systemic sclerosis (SSc)-related interstitial lung disease (ILD). Methods We included participants enrolled in the placebo arm of Scleroderma Lung Study (SLS) I and the MMF arm of SLS II. SLS I randomized participants to receive either oral cyclophosphamide (CYC) or placebo for 1 year, while SLS II randomized participants to receive either MMF for 2 years or oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and SLS II were nearly identical. The primary outcome was % predicted forced vital capacity (FVC), and key secondary outcomes included % predicted diffusing capacity for carbon monoxide (DL co), the modified Rodnan skin thickness score (MRSS), and dyspnea. Joint models were created to evaluate the treatment effect on the course of these outcomes over 2 years. Results At baseline, the MMF-treated group in SLS II (n = 69) and the placebo-treated group in SLS I (n = 79) had similar percentages of men and women and similar disease duration, SSc subtype, extent of skin disease, and % predicted FVC. MMF-treated patients in SLS II were slightly older (mean ± SD age 52.6 ± 9.7 years versus 48.1 ± 12.4 years; P = 0.0152) and had higher % predicted DL co (mean ± SD 54.0 ± 11.1 versus 46.2 ± 13.3; P = 0.0002) than placebo-treated patients in SLS I. After adjustment for baseline disease severity, treatment with MMF in comparison with placebo was associated with improved % predicted FVC ( P < 0.0001), % predicted DL co ( P < 0.0001), MRSS ( P < 0.0001), and dyspnea ( P = 0.0112) over 2 years. Conclusion Although there are inherent limitations in comparing participants from different trials, treatment with MMF was associated with improvements in physiologic outcomes and dyspnea compared with placebo, even after accounting for baseline disease severity. These results further substantiate the use of MMF for the treatment of SSc-related ILD. [ABSTRACT FROM AUTHOR]
- Published
- 2017
- Full Text
- View/download PDF
4. Oligofructose decreases serum lipopolysaccharide and plasminogen activator inhibitor-1 in adults with overweight/obesity.
- Author
-
Parnell, Jill A., Klancic, Teja, and Reimer, Raylene A.
- Subjects
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
- Full Text
- View/download PDF
5. Efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation and heart failure: insights from ENGAGE AF-TIMI 48.
- Author
-
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
- Subjects
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
- Full Text
- View/download PDF
6. Injection frequency of botulinum toxin A for spastic equinus: a randomized clinical trial.
- Author
-
Hastings‐Ison, Tandy, Blackburn, Christine, Rawicki, Barry, Fahey, Michael, Simpson, Pam, Baker, Richard, and Graham, Kerr
- Subjects
EQUINUS deformity ,BOTULINUM A toxins ,CHILDREN with cerebral palsy ,HEALTH outcome assessment ,GAIT in humans ,CLINICAL drug trials ,HEALTH ,THERAPEUTICS ,BOTULINUM toxin ,MUSCLE relaxants ,CEREBRAL palsy ,COMPARATIVE studies ,FUNCTIONAL assessment ,GAIT disorders ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,NEUROLOGIC examination ,NEUROLOGICAL disorders ,QUALITY of life ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,DISEASE complications ,PSYCHOLOGY - Abstract
Aim: We compared two botulinum toxin A (BoNT-A) injection frequency regimens, 12-monthly versus 4-monthly, for spastic equinus in a randomized clinical trial. The primary outcome measure was passive ankle dorsiflexion.Method: Forty-two ambulant children with spastic equinus, secondary to cerebral palsy (23 males and 19 females; mean age 3y 6mo, SD 13mo; GMFCS levels I [n=20], II [n=19], III [n=3]) were randomized to receive either 12-monthly or 4-monthly BoNT-A injections to the calf, over a 26-month period. Twenty-one children had spastic hemiplegia, 21 children had spastic diplegia. A fixed 6U/kg dose of Botox was injected into the gastrocnemius muscle of both limbs in children with diplegia and the gastrocsoleus of the affected limb in children with hemiplegia, under mask anaesthesia.Results: Forty-two children entered the trial with 21 participants randomized to each group. There were three withdrawals and two children received serial casting midway through the trial. There was no significant difference in passive dorsiflexion between 12-monthly and 4-monthly regimens (p=0.41). There were also no significant between group differences on secondary outcome measures. There were no serious adverse events - the rate was 1.2 adverse events per child per year in the 12-monthly group and 2.2 adverse events per child per year in the 4-monthly group. Subgroup analysis revealed a significant difference in passive dorsiflexion between children with hemiplegia and diplegia (p=0.01).Interpretation: There was no significant difference between 12-monthly and 4-monthly injection regimens on passive dorsiflexion or secondary outcome measures. BoNT-A injections for spastic equinus may be recommended on a 12-monthly basis. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
7. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials.
- Author
-
Jankowska, Ewa A., Tkaczyszyn, Michał, Suchocki, Tomasz, Drozd, Marcin, von Haehling, Stephan, Doehner, Wolfram, Banasiak, Waldemar, Filippatos, Gerasimos, Anker, Stefan D., and Ponikowski, Piotr
- Subjects
INTRAVENOUS therapy ,THERAPEUTIC use of iron ,IRON deficiency ,HEART failure patients ,META-analysis ,RANDOMIZED controlled trials ,THERAPEUTICS ,CARDIOVASCULAR disease related mortality ,HEART disease complications ,TRACE elements ,CAUSES of death ,DEFICIENCY diseases ,HOSPITAL care ,IRON ,MORTALITY ,QUALITY of life ,DISEASE progression ,EXERCISE tolerance ,ODDS ratio ,DISEASE complications - Abstract
Aims: The aim of this study was to assess the net clinical and prognostic effects of intravenous (i.v.) iron therapy in patients with systolic heart failure (HF) and iron deficiency (ID).Methods and Results: We performed an aggregate data meta-analysis (random effects model) of randomized controlled trials that evaluated the effects of i.v. iron therapy in iron-deficient patients with systolic HF. We searched electronic databases up to September 2014. We identified five trials which fulfilled the inclusion criteria (509 patients received i.v. iron therapy in comparison with 342 controls). Intravenous iron therapy has been shown to reduce the risk of the combined endpoint of all-cause death or cardiovascular hospitalization [odds ratio (OR) 0.44, 95% confidence interval (CI) 0.30-0.64, P < 0.0001], and the combined endpoint of cardiovascular death or hospitalization for worsening HF (OR 0.39, 95% CI 0.24-0.63, P = 0.0001). Intravenous iron therapy resulted in a reduction in NYHA class (data are reported as a mean net effect with 95% CIs for all continuous variables) (-0.54 class, 95% CI -0.87 to -0.21, P = 0.001); an increase in 6-min walking test distance (+31 m, 95% CI 18-43, P < 0.0001); and an improvement in quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ) score +5.5 points, 95% CI 2.8-8.3, P < 0.0001; European Quality of Life-5 Dimensions (EQ-5D) score +4.1 points, 95% CI 0.8-7.3, P = 0.01; Minnesota Living With Heart Failure Questionnaire (MLHFQ) score -19 points, 95% CI:-23 to -16, P < 0.0001; and Patient Global Assessment (PGA) +0.70 points, 95% CI 0.31-1.09, P = 0004].Conclusion: The evidence indicates that i.v. iron therapy in iron-deficient patients with systolic HF improves outcomes, exercise capacity, and quality of life, and alleviates HF symptoms. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
8. Teaching reading to children with neurofibromatosis type 1: a clinical trial with random assignment to different approaches.
- Author
-
Barquero, Laura A, Sefcik, Angela M, Cutting, Laurie E, and Rimrodt, Sheryl L
- Subjects
NEUROFIBROMATOSIS 1 ,NEUROFIBROMATOSIS in children ,REMEDIAL reading teaching ,CLINICAL trials ,VISUAL perception ,KINESTHETIC method (Education) ,COMPARATIVE studies ,DYSLEXIA ,RESEARCH methodology ,MEDICAL cooperation ,READING ,RESEARCH ,RESEARCH funding ,SPECIAL education ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DISEASE complications ,THERAPEUTICS - Abstract
Aim: Neurofibromatosis type 1 (NF1) is a genetic disorder with a cognitive profile that includes visual-spatial perception deficits and a high incidence of reading disability. There is a paucity of information about how this cognitively complex population responds to mainstream reading interventions. The clinical trial goals were to determine whether children and adolescents with NF1 and reading deficits (NF+RD) benefit from mainstream remedial reading programs and whether responsiveness varies with differences in program-related visual-spatial demands.Method: Forty-nine participants (28 males, 21 females; aged 8-14y) with either NF+RD (n=17, 11 males, six females) or idiopathic reading deficit (IRD) (n=32, 17 males, 15 females) were randomly assigned to intensive remedial teaching using one of two multisensory reading programs: one with greater kinesthetic demands and the other with greater visual-spatial demands. Two control groups - wait-list IRD (n=14, 11 males, three females) and typically developing readers (n=26, 13 males, 13 females) - received no treatment. Repeated measures and multivariate ANOVA analyses compared each group's growth in reading achievement from pre- to post-testing.Results: Treated groups showed significant growth whereas untreated groups did not. Comparing treated groups, the IRD group responded equally well to both interventions, whereas the NF+RD group showed a better response to the more kinesthetic approach.Interpretation: Results suggest that multisensory remedial reading teaching that emphasizes kinesthetic demands more than visual-spatial demands is suitable for students with NF+RD. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
9. Effects of the DASH Diet and Walking on Blood Pressure in Patients With Type 2 Diabetes and Uncontrolled Hypertension: A Randomized Controlled Trial.
- Author
-
Paula, Tatiana P., Viana, Luciana V., Neto, Alessandra T. Z., Leitão, Cristiane B., Gross, Jorge L., and Azevedo, Mirela J.
- Subjects
THERAPEUTICS ,TYPE 2 diabetes treatment ,TYPE 2 diabetes complications ,AMBULATORY blood pressure monitoring ,BLOOD pressure ,BLOOD pressure measurement ,COMPARATIVE studies ,CREATININE ,DIET ,FOOD habits ,HYPERTENSION ,RESEARCH methodology ,MEDICAL cooperation ,TYPE 2 diabetes ,RESEARCH ,WALKING ,EVALUATION research ,BODY mass index ,LIFESTYLES ,RANDOMIZED controlled trials ,DISEASE complications - Abstract
Data on the potential beneficial effects of combining diet and exercise on blood pressure (BP) are still scarce. A 4-week randomized controlled clinical trial was undertaken in 40 hypertensive patients with type 2 diabetes with uncontrolled blood pressure (BP) in office and daytime ambulatory BP monitoring (ABPM). Patients were assigned to follow a Dietary Approaches to Stop Hypertension (DASH) diet associated with advice to increase walking using a pedometer (intervention group) or a diet based on the American Diabetes Association recommendations (control group). The lifestyle intervention caused a greater ABPM (mm Hg) reduction in systolic 24-hour, diastolic 24-hour, nighttime systolic, daytime systolic, and daytime diastolic measurements than observed in the control group. In the intervention group there was a decrease in urinary sodium and an increase in urinary potassium, plasma aldosterone, and the number of steps per day (P<.05). The DASH diet and increased walking were associated with clinically significant reductions in ABPM values in hypertensive patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]
- Published
- 2015
- Full Text
- View/download PDF
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.