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Author: Okan Elci (33)


Aug
2017

Phase 1 studies have shown potential benefit of gene replacement in RPE65-mediated inherited retinal dystrophy. This phase 3 study assessed the efficacy and safety of voretigene neparvovec in participants whose inherited retinal dystrophy would otherwise progress to complete blindness.
In this open-label, randomised, controlled phase 3 trial done at two sites in the USA, individuals aged 3 years or older with, in each eye, best corrected visual acuity of 20/60 or worse, or visual field less than 20 degrees in any meridian, or both, with confirmed genetic diagnosis of biallelic RPE65 mutations, sufficient viable retina, and ability to perform standardised multi-luminance mobility testing (MLMT) within the luminance range evaluated, were eligible.

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Jun
2017

The Neonatal Resuscitation Program (NRP) guidelines recommend positive pressure ventilation (PPV) in the first 60s of life to support perinatal transition in non-breathing newborns. Our aim was to describe the incidence and characteristics of newborn PPV using real-time observation in the delivery unit.
Prospective, observational, quality improvement study conducted at a tertiary academic hospital.

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Aug
2017

High-quality cardiopulmonary resuscitation (CPR) is critical to improve survival from cardiac arrest. However, cardiopulmonary resuscitation knowledge and psychomotor skill proficiency are transient. We hypothesized that brief, in situ refresher training will improve chest compression (CC) psychomotor skill retention for bedside providers.

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Jan
2017

Pain of intravenous (IV) catheter insertion can be mitigated with appropriate analgesia, thereby avoiding unnecessary distress. Our objective was to compare the self-reported pain of IV catheter insertion in children when using a vibrating cold device (VCD) versus standard of care 4% topical lidocaine cream (TL).
This was a 2-arm randomized controlled noninferiority trial with a convenience sample of 4- to 18-year-olds requiring nonemergent IV catheter insertion.

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Feb
2017

Patients with a single ventricle experience a high rate of brain injury and adverse neurodevelopmental outcome; however, the incidence of brain abnormalities throughout surgical reconstruction and their relationship with cerebral blood flow, oxygen delivery, and carbon dioxide reactivity remain unknown.
Patients with a single ventricle were studied with magnetic resonance imaging scans immediately prior to bidirectional Glenn (pre-BDG), before Fontan (BDG), and then 3 to 9 months after Fontan reconstruction.
One hundred sixty-eight consecutive subjects recruited into the project underwent 235 scans: 63 pre-BDG (mean age, 4.

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Dec
1969

The authors enrolled 95 patients in a primary care office who presented with a concussion. Of these patients, 63% were sport concussions. The authors matched 90 of these patients to children in the authors' practice presenting for sports physicals or regular check-ups in the following demographics: age, participating in a particular sport, having attention-deficit disorder/attention-deficit hyperactivity disorder, gender, and grade.

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Dec
1969

Immediate cognitive and physical rest in the concussed patient is almost universally recommended in the concussion literature. The authors conducted a prospective observational in a primary care pediatric office to examine the effect of delayed cognitive and physical rest had on recovery time in pediatric concussion. The authors found that patients who started cognitive and physical rest immediately after injury were more likely to recover within 30 days compared to patients who delayed cognitive and physical rest for 1-7 days after their injury (67% vs 35%, P = .

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Dec
1969

Effective interventions for older adults are needed to address lifestyle behaviors linked to chronic illnesses. We implemented a 12-week group behavioral intervention for 118 racially diverse older adults at 6 community-based senior centers to improve eating and physical activity. Assessments were completed pre- and postintervention, with 85.

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Aug
2016

Safety and efficacy have been shown in a phase 1 dose-escalation study involving a unilateral subretinal injection of a recombinant adeno-associated virus (AAV) vector containing the RPE65 gene (AAV2-hRPE65v2) in individuals with inherited retinal dystrophy caused by RPE65 mutations. This finding, along with the bilateral nature of the disease and intended use in treatment, prompted us to determine the safety of administration of AAV2-hRPE65v2 to the contralateral eye in patients enrolled in the phase 1 study.
In this follow-on phase 1 trial, one dose of AAV2-hRPE65v2 (1.

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Aug
2016

Both genetics and physical activity (PA) contribute to bone mineral density (BMD), but it is unknown if the benefits of physical activity on childhood bone accretion depend on genetic risk. We, therefore, aimed to determine if PA influenced the effect of bone fragility genetic variants on BMD in childhood. Our sample comprised US children of European ancestry enrolled in the Bone Mineral Density in Childhood Study (N = 918, aged 5 to 19 years, and 52.

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Dec
2016

Pancreatic enzyme therapy does not normalize dietary fat absorption in patients with cystic fibrosis and pancreatic insufficiency. Efficacy of LYM-X-SORB (LXS), an easily absorbable lipid matrix that enhances fat absorption, was evaluated in a 12-month randomized, double-blinded, placebo-controlled trial with plasma fatty acids (FA) and coefficient of fat absorption (CFA) outcomes. A total of 110 subjects (age 10.

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Mar
2016

Scarce data exist regarding costs of pediatric heart failure-related hospitalizations (HFRH) or how costs have changed over time. Pediatric HFRH costs, due to advances in management, will have increased significantly over time. A retrospective analysis of Healthcare Cost and Utilization Project Kids' Inpatient Database was performed on all pediatric HFRH.

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Apr
2016

Using adult identified bone mineral density (BMD) loci, we calculated genetic risk scores (GRS) to determine if they were associated with changes in BMD during childhood. Longitudinal data from the Bone Mineral Density in Childhood Study were analyzed (N = 798, 54% female, all European ancestry). Participants had up to 6 annual dual energy X-ray scans, from which areal BMD (aBMD) Z-scores for the spine, total hip, and femoral neck were estimated, as well as total body less head bone mineral content (TBLH-BMC) Z-scores.

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Apr
2016

Choline depletion is seen in cystic fibrosis (CF) and pancreatic insufficiency in spite of enzyme treatment and may result in liver, fatty acid, and muscle abnormalities. This study evaluated the efficacy and safety of an easily absorbed choline-rich structured lipid (LYM-X-SORB™ [LXS]) to improve choline status.
Children with CF and pancreatic insufficiency were randomized to LXS or placebo in a 12-month double blind trial.

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Aug
2015

Patients with single ventricle can develop aortic-to-pulmonary collaterals (APCs). Along with systemic-to-pulmonary artery shunts, these structures represent a direct pathway from systemic to pulmonary circulations, and may limit cerebral blood flow (CBF). This study investigated the relationship between CBF and APC flow on room air and in hypercarbia, which increases CBF in patients with single ventricle.

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May
2015

We evaluated safety, antiviral, immunomodulatory and anti-inflammatory properties of aprepitant - a neurokinin 1 receptor antagonist.
Phase IB randomized, placebo-controlled, double-blinded study.
Eighteen patients were randomized (nine to aprepitant and nine to placebo).

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Sep
2015

We aimed to determine if adult bone mineral density (BMD) susceptibility loci were associated with pediatric bone mass and density, and if sex and pubertal stage influenced any association. We analyzed prospective areal BMD (aBMD) and bone mineral content (BMC) data from the Bone Mineral Density in Childhood Study (n = 603, European ancestry, 54% female). Linear mixed models were used to assess if 77 single-nucleotide polymorphisms (SNPs) near known adult BMD susceptibility loci interacted with sex and pubertal stage to influence the aBMD/BMC; adjusting for age, BMI, physical activity, and dietary calcium.

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Jun
2015

The inclusion of dexmedetomidine in the operative and postoperative management of infants with congenital heart defects has lessened the need for opioids that may cause respiratory depression. Our objective was to show that a dexmedetomidine bolus at or about the time of sternal closure is associated with a decrease in the use of mechanical ventilation in the immediate postoperative period.
Retrospective cohort study.

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Mar
2015

Worldwide, 6.6 million children die each year, partly due to a failure to recognize and treat acutely ill children. Programs that improve provider recognition and treatment initiation may improve child survival.

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Dec
2013

Although one in five U.S. adults continue to smoke, healthcare providers often fail to provide basic, effective interventions.

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Jan
2014

In every study involving human immune parameters, large inter-subject variability occurs which can make interpretation of results difficult. The aim of this study was to evaluate whether genetic variants in cytokine receptors could associate with variability in laboratory immune measures. A total of 207 normal volunteers were recruited in this study.

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Dec
2013

To determine if computed tomographic (CT) texture and histogram analysis measurements of the primary mass are independently associated with overall survival in patients with locally advanced squamous cell carcinoma of the head and neck who were previously treated with cisplatin, 5-fluorouracil, and docetaxel (TPF) induction chemotherapy.
This institutional review board-approved retrospective study included 72 patients with locally advanced squamous cell carcinoma of the head and neck who were treated with induction TPF chemotherapy in 2004-2010. CT texture and histogram analysis of the primary mass on the pretherapy CT images were performed by using TexRAD software before and after application of spatial filters at different anatomic scales ranging from fine detail to coarse features.

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Dec
1969

Marathon training is both physically and psychologically stressful, both of which can lead to altered immunity. The purpose of this study was to determine if the overall immunoregulatory changes associated with the physical stress of marathon training are affected by psychological stress.
Nineteen recreational marathoners completed the Perceived Stress Scale (PSS), State-Trait Anxiety Inventory (STAI) and Penn State Worry Questionnaire (PSWQ), and had levels of T cell subpopulations and cytokine (IFNγ, IL4 and IL10) production determined 4 weeks before (baseline), 24-48 h before (prerace) and 1 week after (recovery) participation in a marathon.

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Jul
2012

The purpose of this study was to assess children's comprehension of a new assent booklet, (K(id)S(ent)), which uses pictures and written information.
A randomized, crossover study evaluated the comprehension of assent documents by children, 7 to 11 years of age at a local elementary school. The two types of documents tested were the standard assent form and the K(id)S(ent) Assent Booklet.

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Dec
2013

Integral components of behavioral weight-loss treatment include self-monitoring of diet and physical activity along with feedback to participants regarding their behaviors. While providing feedback has been associated with weight loss, no studies have examined the impact of feedback frequency on weight loss or the mediating role of self-monitoring adherence in this relationship.
This study examined the effect of participant feedback frequency on weight loss and determined if this effect was mediated by adherence to self-monitoring in a behavioral weight-loss trial conducted in the USA.

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Dec
1969

Interpretation of laboratory immune data in healthy human subjects is often challenging due to wide inter-subject variability. Since endocrine and immune mediators have been mutually interlinked, a potential explanation for the significant variability seen in immune data even when controlled for technical variability and demographics is differences in the binding affinity of ligand with hormone receptors on the surface of immune cells, which can be associated with single nucleotide polymorphisms (SNP).
We categorized immunoregulatory cellular profiles from PBMC of 207 healthy volunteers according to glucocorticoid receptor (GR: Bcl1, TthIIII, and A3669G) and β₂-adrenergic receptor (β2AR: Gly16Arg and Gln27Glu) polymorphisms.

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Apr
2011

Self-monitoring has traditionally been done using a paper record, which can be tedious and burdensome. A personal digital assistant (PDA) with dietary software can provide an alternative to a paper record. The study aimed to describe the differences in dietary changes at 6 months between participants randomly assigned to use a paper record or PDA for self-monitoring in a clinical trial of weight-loss treatment.

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Aug
2011

Weight loss has been associated with higher physical activity (PA) levels and frequent dietary self-monitoring. Less is known about how PA self-monitoring affects adherence to PA goals, PA levels, and weight change.
The SMART Trial is a clinical weight loss trial in which 210 overweight adults were randomized equally to one of three arms: 1) paper record (PR), 2) personal digital assistant with self-monitoring software (PDA), and 3) PDA with daily tailored feedback message (PDA + FB).

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Feb
2011

Technology may improve self-monitoring adherence and dietary changes in weight loss treatment. Our study aimed to investigate whether using a personal digital assistant (PDA) with dietary and exercise software, with and without a feedback message, compared to using a paper diary/record (PR), results in greater weight loss and improved self-monitoring adherence. Healthy adults (N = 210) with a mean BMI of 34.

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Nov
2009

To describe participants' adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases.
A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions.

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Jan
2010

Few studies have reported longitudinal relationships between physical activity (PA) and cardiometabolic risk factors over time using repeated assessments in overweight or obese adults. We conducted a longitudinal study in 127 participants (81% with body mass index > 30 kg/m(2)) who completed a 12-month behavioral intervention for weight loss between 2003 and 2005 in Pittsburgh, PA, USA. Using absolute change scores from baseline to each time point (i.

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Nov
2009

The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA).

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Sep
2007

A vegetarian diet may lead to numerous health benefits, including weight loss.
We examined the joint effects of personal preference of dietary treatment and a calorie-restricted, low-fat lactoovovegetarian diet (LOV-D) compared with a standard calorie-restricted, low-fat omnivorous diet (STD-D) on changes in weight, total cholesterol, ratio of LDL to HDL cholesterol (LDL:HDL cholesterol), triacylglycerols, insulin resistance, and macronutrient intake during an 18-mo study.
This was a randomized clinical trial of 176 overweight and obese adults who were recruited and randomly assigned first to 1 of 2 preference conditions (yes or no).

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