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Birth Weight and Diabetic Retinopathy: Results From the Population-Based Gutenberg Health Study (GHS).

2020

Purpose: This study investigates the relationship between diabetic retinopathy (DR) and birth weight (BW) in diabetic subjects sampled from the general population. Methods: The Gutenberg Health Study (GHS) is a population-based, observational cohort study in participants aged from 35 to 74 years. Criteria for diabetes diagnosis were HbA1c ≥6.5% at study entry, a doctor-diagnosis of diabetes, or diabetes medication. The presence of DR was determined by evaluating fundus photographs. BW was assessed by self-reports. GHS participants were divided into three different BW groups (low: <2500 g; normal: 2500–4000 g; high:>4000 g). Logistic regression analysis was conducted as uni- and multiv…

The INMA INfancia y Medio Ambiente-(Environment and Childhood) project: More than 10 years contributing to environmental and neuropsychological resea…

2017

Background: In 2003 the INMA—INfancia y Medio Ambiente (Environment and Childhood) project, a Spanish national network of birth cohorts including more than 3500 participants, was set up with the aim to assess the health impacts of pre- and postnatal environmental exposures on children. The project has published more than 60 papers on maternal and environmental factors related to neuropsychological development in children, one of the main research interests within the project. With the present review, we evaluate the evidence provided by the INMA project on this topic and discuss how the data can contribute to cover the challenges that children’s environmental health research will face in th…

Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder

2015

Importance Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD. Objective To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo. Design, Setting, and Participants Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessmen…

2014

BACKGROUND: Preterm birth, low birth weight, and infant catch-up growth seem associated with an increased risk of respiratory diseases in later life, but individual studies showed conflicting results. OBJECTIVES: We performed an individual participant data meta-analysis for 147,252 children of 31 birth cohort studies to determine the associations of birth and infant growth characteristics with the risks of preschool wheezing (1-4 years) and school-age asthma (5-10 years). METHODS: First, we performed an adjusted 1-stage random-effect meta-analysis to assess the combined associations of gestational age, birth weight, and infant weight gain with childhood asthma. Second, we performed an adjus…

Comparison of the ability of alternative birthweight and fetal weight standards to identify preterm newborns at increased risk of perinatal death

2013

Objective To compare prediction of perinatal deaths among preterm infants based on fetal weight standards versus a new subpopulation-based birthweight standard. Design Population-based cohort study. Setting France. Population A total of 9100 preterm singletons, born between 24 and 36 weeks of gestation in 2000–09, in Burgundy (France). Methods We first classified all newborns as either small for gestational age (SGA) or not, based on alternative fetal weight or birthweight standards, including a new birthweight standard that excludes infants born to mothers with disease related to the weight of a fetus. Based on discrepancies between the different classifications, we then divided the newbor…

Parental informed consent in pediatric cancer trials: A population-based survey in Germany

2012

In Germany, nearly every child afflicted by a malignant dis-ease or a central nervous system tumor is enrolled in a clinicaltrial during treatment. Many of these children are under the age of5 years when they are first diagnosed [1]. The decision whether ornot to participate in a clinical trial is normally made by theparents on behalf of their child. Therefore, ensuring adequatelyinformed parental consent is essential to ethical practice in pedi-atric oncology.However, many empirical studies have revealed difficultieswith the informed consent process when parents are faced withthe decision to enroll their child in a clinical trial. Previous studyfindings have indicated that recalling signing th…

Coronary artery bypass graft versus percutaneous coronary intervention with drug-eluting stent implantation for diabetic patients with unprotected le…

2013

textabstractAims: Data regarding the impact on clinical outcomes of PCI with DES implantation vs. CABG to treat unprotected left main coronary artery (ULMCA) disease in diabetic patients are still insufficient. The present study evaluated the short-term and long-term results of percutaneous and surgical revascularisation in diabetic patients with ULMCA disease in a large population. Methods and results: A total of 826 diabetic patients with ULMCA stenosis who received DES (n=520) or underwent CABG (n=306) were selected and analysed from the DELTA registry. In-hospital MACCE was significantly higher in the CABG group, mainly driven by a higher incidence of MI. At four-year follow-up, freedom…

Five-year outcomes following timely primary percutaneous intervention, late primary percutaneous intervention, or a pharmaco-invasive strategy in ST-…

2019

Abstract Aims ST-segment elevation myocardial infarction (STEMI) guidelines recommend primary percutaneous coronary intervention (pPCI) as the default reperfusion strategy when feasible ≤120 min of diagnostic ECG, and a pharmaco-invasive strategy otherwise. There is, however, a lack of direct evidence to support the guidelines, and in real-world situations, pPCI is often performed beyond recommended timelines. To assess 5-year outcomes according to timing of pPCI (timely vs. late) compared with a pharmaco-invasive strategy (fibrinolysis with referral to PCI centre). Methods and results The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) programme c…

Diagnostic accuracy of clinical parameters to monitor peri-implant conditions: A matched case-control study

2018

International audience; Background: The aim of this case-control study was to estimate the diagnostic accuracy of the standard clinical parameters in diagnosing healthy peri-implant tissues, peri-implant mucositis, and peri-implantitis.Methods: A case-control study was designed to compare the clinical parameters used in the diagnosis of peri-implant diseases such as: probingdepth (PD), bleeding on probing (BOP), mucosal redness (MR), suppuration (SUP), and plaque index (PI). Furthermore, the influence of patient-(sex, age) and implant-related variables (implant neck configuration, time in function after loading) were evaluated to investigate the association with the clinical findings. The i…

A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic ha…

2021

BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who re…