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Author: Philippe Lehert (75)


Feb
2018

Metformin treatment is associated with a decrease of serum vitamin B12, but whether this reflects tissue B12 deficiency is controversial. We studied the effects of metformin on serum levels of methylmalonic acid (MMA), a biomarker for tissue B12 deficiency, and on onset or progression of neuropathy.
In the HOME trial, 390 insulin-treated patients with type 2 diabetes were treated with metformin or placebo for 52months.

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Nov
2017

The administration of adrenaline is a life-saving intervention for anaphylactic reactions. However, it has been questioned whether the needle length of the autoinjectors is sufficient to achieve genuine intramuscular delivery and optimal bioavailability.
To assess the adequacy of Anapen, which has a relatively short needle length (10.

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Mar
2018

In this trial, 390 insulin-treated patients with type 2 diabetes were randomized to either placebo or metformin. Fasting levels of glucose, insulin and C peptide were determined at baseline, after 4 months and yearly thereafter for 4 years to assess fasting estimates of beta cell function. The primary endpoint was the fasting C peptide-to-glucose ratio (FCPGR) and secondary measures were the disposition index (DI) and the fasting C peptide (FCP).

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Jan
2018

Metformin prevents weight gain in patients with type 2 diabetes (T2D). However, the mechanisms involved are still unknown. In this post hoc analysis of the HOME trial, we aimed to determine whether metformin affects energy intake.

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Dec
1969

Vascular disease remains a leading cause of death. There are several vascular risk factors identified that can mitigate development of disease in ageing. We examine reported rates of modifiable risk factors in women responding to an online health questionnaire advertised by popular media.

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Dec
1969

Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy.
For this randomised, double-blind, placebo-controlled trial we recruited patients with narcolepsy from 16 sleep centres in nine countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia, Turkey, and Ukraine).

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Dec
1969

Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD.

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Oct
2016

Abnormalities in brain structure and function can occur several decades prior to the onset of cognitive decline. It is in the preceding decades that an intervention is most likely to be effective, when informed by an understanding of factors contributing to the disease prodrome. Few studies, however, have sufficient longitudinal data on relevant risks to determine the optimum targets for interventions to improve cognition in aging.

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Dec
1969

Elafibranor is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic steatohepatitis (NASH).

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Jun
2015

CMT1A is the most common inherited peripheral neuropathy. There is currently no approved treatment. We performed a meta-analysis including four randomized, double-blind, Placebo-controlled clinical trials to assess the disease progression after one year under Placebo, Ascorbic Acid (AA) or PXT3003, a combination of three repurposed drugs.

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Jul
2015

To validate the Sustained Attention to Response Task (SART) as a treatment effect measure in narcolepsy, and to compare the SART with the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).
Validation of treatment effect measurements within a randomized controlled trial (RCT).
Ninety-five patients with narcolepsy with or without cataplexy.

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Jul
2015

Sleep disturbance constitutes a major risk factor for drinking relapse after alcohol withdrawal and necessitates regular follow-up. We reported previously that the sum-score of the 4 sleep items of the Hamilton Anxiety and Depression Scales (the Short Sleep Index [SSI]) constitutes a valid and simple sleep measurement tool. The objective of this study was to evaluate the psychometric features of the SSI relative to the lengthier Pittsburgh Sleep Quality Index (PSQI), which is widely used for measuring sleep disturbance in patients with alcohol use disorders during and after alcohol withdrawal.

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Dec
2014

Charcot-Marie-Tooth type 1A disease (CMT1A) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein PMP22, which induces abnormal Schwann cell differentiation and dysmyelination, eventually leading to axonal suffering then loss and muscle wasting. We favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways. In CMT1A patients, we therefore tested the potential of PXT3003, a low-dose combination of three already approved compounds (baclofen, naltrexone and sorbitol).

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Jan
2015

We assessed the predictive value added by Anti-Mullerian Hormone (AMH) to currently validated live birth (LB) prediction models.
Based on recent data from our center, we compared the external validity of the Templeton Model (TM) and its recent improvement (TMA) to select our model of reference. The added predictive value of AMH was assessed in testing the likelihood ratio significance and the Net Reclassification Index (NRI).

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Jan
2015

Multiple sclerosis (MS) has a major impact on quality of life (QoL). Coping strategies which may influence QoL have not been identified. Furthermore, there is no coping scale designed to measure coping in MS patients and concise enough for routine medical practice.

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Aug
2014

There is a paucity of longitudinal studies assessing sexual function of women in the late postmenopause.
This study aims to describe sexual function of women in the late postmenopause and to investigate change from early postmenopause.
Cross-sectional analysis of 2012/13 and longitudinal analysis from 2002/04 of the population based, Australian cohort of the Women's Healthy Ageing Project, applying validated instruments: Short Personal Experience Questionnaire (SPEQ), Female Sexual Distress Scale (FSDS), Hospital Anxiety and Depression Scale, Geriatric Depression Scale, and California Verbal Learning Test.

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Jun
2014

To determine the impact of the time interval from the end of sperm preparation (TSP) to intrauterine insemination (IUI) on the outcome.
Prospective multicentre cohort study.
Seven French centers (assisted reproduction group in northeastern France, four academic centers, and three clinics).

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Feb
2014

The potential benefit of adding recombinant human luteinizing hormone (r-hLH) to recombinant human follicle-stimulating hormone (r-hFSH) during ovarian stimulation is a subject of debate, although there is evidence that it may benefit certain subpopulations, e.g. poor responders.

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Nov
2013

Narcolepsy is characterised by excessive daytime sleepiness (EDS) and cataplexy. Histamine neurons are crucial to maintain wakefulness. We assessed the safety and efficacy of pitolisant (previously called BF2.

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Jan
2013

Women having experienced several consecutive failing IVF cycles constitute a critical and particular subset of patients, for which growing perception of irremediable failure, increasing costs and IVF treatment related risks necessitate appropriate decision making when starting or not a new cycle. Predicting chances of LB might constitute a useful tool for discussion between the patient and the clinician. Our essential objective was to dispose of a simple and accurate prediction model for use in routine medical practice.

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Dec
2012

Naftidrofuryl for intermittent claudication.

Cochrane Database Syst Rev 2012 Dec 12;12:CD001368. Epub 2012 Dec 12.
Tine L M de Backer, Robert Vander Stichele, Philippe Lehert, Luc Van Bortel
Lifestyle changes and cardiovascular prevention measures are a primary treatment for intermittent claudication (IC). Symptomatic treatment with vasoactive agents (Anatomic Therapeutic Chemical Classification (ATC) for medicines from the World Health Organisation class CO4A) is controversial.
To evaluate evidence on the efficacy and safety of oral naftidrofuryl (ATC CO4 21) versus placebo on the pain-free walking distance (PFWD) of people with IC by using a meta-analysis based on individual patient data (IPD).

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Jan
2013

Surgical site infection (SSI) is a major concern in colorectal surgery (CRS). It accounts for 60 % of all postoperative complications and has an incidence of between 10 and 30 %. The gentamicin-collagen sponge (GCS) was developed to help avoid SSI.

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Aug
2012

Optimal blood pressure (BP) targets are still controversial in end-stage renal disease. Recent data have highlighted shortcomings of the usual BP hypothesis in other patient populations and emphasized the importance of visit-to-visit variability of BP in predicting cardiovascular events. The Fosinopril in Dialysis Study failed to demonstrate the efficacy of 2-year angiotensin-converting enzyme inhibition with fosinopril versus placebo in 397 hemodialysis patients with left ventricular hypertrophy but provided an opportunity to assess the influence of BP variability on cardiovascular events.

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Jun
2012

Euthyroid goiter is frequent for general practitioners (GPs) and endocrinologists (ENDOs). It may induce complications especially in elderly subjects when it becomes nodular and hyperfunctional whereas in young subjects prevention of iodine deficiency may prevent this evolution. The primary objective of the observational study diagnosis of iodine deficiency induced goiter and national medical practices (DIAGONALE) was to determine the circumstances of diagnosis of euthyroid goiter, its incidence, the patient characteristics and the management.

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Jun
2012

The aim of this paper is to review published literature on the types and prevalences of premenstrual disorders and symptoms, and effects of these on activities of daily life and other parameters of burden of illness. The method involved review of the pertinent published literature. Premenstrual disorders vary in prevalence according to the definition or categorization.

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Jun
2012

Sleep disturbance symptom (SDS) is commonly reported in alcoholic patients. Polysomnography studies suggested that acamprosate decreased SDS. We assessed this hypothesis by using data of a randomized controlled trial.

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Sep
2011

To determine patterns of premenstrual symptom experiences across the reproductive age range, and the effects of other factors on premenstrual symptoms.
Global cross-sectional survey. Sample A total of 7226 women aged 15-49 recruited by random sampling with approximately 400 each from France, Germany, Hungary, Italy, Spain, UK, Brazil, Mexico, Hong Kong, Pakistan and Thailand.

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Sep
2011

To determine cross-cultural and other effects on women's experiences of premenstrual symptoms and their impact on activities of daily life (ADL).
Cross-sectional survey. Sample A total of 7226 women aged 15-49 recruited by random sampling with approximately 400 each from France, Germany, Hungary, Italy, Spain, UK, Brazil, Mexico, Hong Kong, Pakistan and Thailand.

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Mar
2012

It is unknown whether women derive comparable benefits and have a similar safety and tolerability profile as men from acamprosate, a widely prescribed drug for the maintenance of abstinence in alcohol dependence. The objective of this study was to assess sex-specific differences in the efficacy, safety, and tolerability of acamprosate in the treatment of women and men with alcohol dependence.
A sex-specific meta-analysis was conducted based on individual patient data (IPD).

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Sep
2011

Racecadotril is an antidiarrhoeal drug with intestinal antisecretory mechanism of action.
To assess racecadotril efficacy as an adjunct to oral rehydration solution, against oral rehydration solution alone or with placebo in childhood acute gastroenteritis.
Individual patient data meta-analysis following multilevel mixed models testing the significance of the treatment effect adjusted for baseline covariates.

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Dec
2010

The aim of this paper is to assess the effects of premenstrual symptoms on quality of life as measured by the impact symptoms have on women's activities of daily life (ADL).
Cross-sectional survey. Population-based, face-to-face interview with 1202 women aged 15-49 years recruited by random sampling in cities of Hong Kong, Pakistan and Thailand.

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Dec
2010

This paper aims to explore women's experiences of premenstrual symptoms in three Asian countries and the factors affecting the prevalence of these symptoms.
Cross-sectional survey. A sample of 1202 women aged 15-49 years were recruited by random sampling in Hong Kong, Pakistan and Thailand.

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Dec
2010

To examine the predictors and correlates of depression in alcoholic patients following detoxification and during outpatient treatment, and the role of acamprosate.
The international research program of acamprosate has involved 6500 patients in randomized, placebo-controlled trials. Extensive baseline and follow-up data were documented for each patient.

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Sep
2010

Human menopausal gonadotrophins and recombinant human follicle stimulating hormone are the two main gonadotrophin products utilized for controlled ovarian stimulation in assisted reproductive technologies. In this meta-analysis, the number of oocytes was designated as the most relevant endpoint directly resulting from ovarian stimulation, and therefore where the drug effect may be estimated with the best sensitivity.
All published randomized controlled trials on ovarian stimulation comparing the two gonadotrophin products were evaluated.

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Sep
2010

Alcohol dependence is among the main leading health risk factors in most developed and developing countries. Therapeutic success of psychosocial programs for relapse prevention is moderate, but could potentially be increased by an adjuvant treatment with the glutamate antagonist acamprosate.
To determine the effectiveness and tolerability of acamprosate in comparison to placebo and other pharmacological agents.

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Oct
2010

The aim of this study is to assess the influence of early and late compliance of acamprosate on attendance and abstinence duration in the treatment of alcohol dependence.
Individual patient data of 2,305 patients from 11 randomized controlled trials comparing acamprosate (n = 1,128) with placebo (n = 1,177) were used to predict early and late compliance and to study the effect of early and late compliance on attendance and abstinence duration using regression analysis and structural equation modeling.
Early compliance was predicted by baseline motivation to become fully abstinent and baseline abstinence (R(2) = .

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May
2010

To study the effects of metformin on the incidence of vitamin B-12 deficiency (<150 pmol/l), low concentrations of vitamin B-12 (150-220 pmol/l), and folate and homocysteine concentrations in patients with type 2 diabetes receiving treatment with insulin.
Multicentre randomised placebo controlled trial.
Outpatient clinics of three non-academic hospitals in the Netherlands.

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May
2010

This secondary analysis of the first U.S. acamprosate trial (N = 601) for alcohol dependence examines the effects of subsyndromal psychiatric symptoms or history of severe psychopathology on alcoholism treatment outcomes and any mitigating effects of acamprosate.

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Mar
2010

To evaluate the impact of premenstrual symptoms on activities of daily life (ADL) of Korean women, and their knowledge and treatment seeking regarding premenstrual syndromes (PMSs).
A population-based online survey regarding premenstrual symptoms was conducted in 1000 Korean women aged 15-49 years. Symptoms were classified according to their intensity, persistence each cycle, and impairment of ADL.

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Sep
2009

Determine women's experiences of premenstrual symptoms.
Cross-sectional survey. Sample In all, 4085 women aged 14-49 years recruited by random telephone digit dialing in France, Germany, Hungary, Italy, Spain, UK, Brazil and Mexico.

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Sep
2009

: To evaluate the effect of current smoking and lifetime illicit drug use on alcoholism treatment outcomes and to assess whether these factors influence acamprosate efficacy.
: This is a secondary analysis of data from the intention-to-treat population (N = 601) in a 6-month, randomized, placebo-controlled US trial of acamprosate (2 or 3 g/d). Patients met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria for alcohol dependence and no other dependence disorders other than nicotine or cannabis, although patients with recent substance use were included.

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Aug
2010

To assess impact of premenstrual symptoms on activities of women's daily lives (ADL).
Cross-sectional population-based survey.
Market research company.

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Jun
2009

Limited published data address the impact of low sexual desire and interest on multiple domains of women's partnered relationships.
To investigate associations between sexual interest and attitudes toward and frequency of partner interactions in women with reduced sexual desire.
A cross-sectional study was conducted using market research databases to recruit women from the general community in the United States, Germany, and Italy.

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Mar
2009

We investigated whether metformin hydrochloride has sustained beneficial metabolic and (cardio) vascular effects in patients with type 2 diabetes mellitus (DM2).
We studied 390 patients treated with insulin in the outpatient clinics of 3 hospitals in a randomized, placebo-controlled trial with a follow-up period of 4.3 years.

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Mar
2009

Across a woman's lifetime, variations in hormone levels are known to influence mood and well-being. Whether absolute or changes in hormone levels over time are associated with depression among postmenopausal women remains unclear.
The Melbourne Women's Midlife Health Project is a longitudinal population-based study of women who were followed through the menopausal transition.

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Oct
2008

Previous, population-based studies investigating the risk factors for sexual distress have not drawn on longitudinal data.
Determine the prevalence of sexual distress and dysfunction, explore factors associated with/predictive of sexual distress, and describe changes in sexual function over a decade in a population-based sample of mid-aged women.
Eleven-year prospective study of Australian-born women, aged 45-55 years, and menstruating at baseline.

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Apr
2008

Narcolepsy is characterized by excessive daytime sleepiness (EDS), cataplexy, direct onsets of rapid eye movement (REM) sleep from wakefulness (DREMs) and deficiency of orexins, neuropeptides that promote wakefulness largely via activation of histamine (HA) pathways. The hypothesis that the orexin defect can be circumvented by enhancing HA release was explored in narcoleptic mice and patients using tiprolisant, an inverse H(3)-receptor agonist. In narcoleptic orexin(-/-) mice, tiprolisant enhanced HA and noradrenaline neuronal activity, promoted wakefulness and decreased abnormal DREMs, all effects being amplified by co-administration of modafinil, a currently-prescribed wake-promoting drug.

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Jan
2008

Two pharmacological agents have repeatedly been shown to be efficacious for relapse prevention in alcohol dependence: The putative glutamate-antagonist acamprosate and the opioid-antagonist naltrexone. Clinical evidence for both drugs is based on various outcome criteria. Whereas for acamprosate primarily abstinence maintenance has been demonstrated, studies with naltrexone have mostly emphasised the prevention of heavy drinking.

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