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NCT ID: NCT03008135 Completed - Frail Elderly Clinical Trials

Reliability and Validity of the Elderly Mobility Scale, French Version

Start date: March 21, 2017
Phase: N/A
Study type: Observational

This study evaluates the reliability of the French version of the "elderly mobility scale" and its correlation with the "frailty elderly scale "

NCT ID: NCT03008070 Completed - Clinical trials for Non-Alcoholic Steatohepatitis (NASH)

Phase 2b Study in NASH to Assess IVA337

NATIVE
Start date: February 7, 2017
Phase: Phase 2
Study type: Interventional

Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.

NCT ID: NCT03007277 Completed - Clinical trials for Mental Health Wellness 1

Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines

PANJO
Start date: October 2016
Phase: N/A
Study type: Interventional

The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.

NCT ID: NCT03007108 Completed - Healthy Infants Clinical Trials

Age-dependency of Thrombin Generation Using a New Standardized Assay

TGT
Start date: January 10, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesiaâ„¢" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults > 18 years old).

NCT ID: NCT03007095 Completed - Preterm Children Clinical Trials

Preterm Birth and Social Cognition

TERM-COG
Start date: July 20, 2017
Phase: N/A
Study type: Interventional

The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

NCT ID: NCT03006926 Completed - Clinical trials for Hepatocellular Carcinoma

A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma

Start date: February 13, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

NCT ID: NCT03006016 Completed - Clinical trials for Morbid Obesity D009765

Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis

Omegobese
Start date: April 12, 2017
Phase: N/A
Study type: Interventional

Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on ultrasounds. The aim of this study is to determine whether a 4-week preoperative course with omega-3 without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume and its fat content, rendering thus surgery easier. The primary end point is the reduction of the volume of the left liver lobe as measured by magnetic resonance imaging. Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver injuries during surgery, and duration of surgery, the evolution of liver tests as well as the correlation between preoperative MRI data and intraoperative liver biopsy for the quantification of liver steatosis. Study design: This is an interventional, prospective, multicentric, randomized, double blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients in 12 months. Study time schedule: At the time of the enrollment visit two visits are scheduled, the first before the beginning of the study and the last at the end. Surgery is scheduled no more than 7 days after the end of the treatment. At time of these two visits a clinical examination is performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein) and a MRI to evaluate the volume and the fat content of the liver. At time of surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is performed. The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a reduction in the volume of the left liver lobe of 20 %. Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in a significant reduction of liver volume and steatosis before bariatric surgery, it may be recommended as a systematic preoperative treatment.

NCT ID: NCT03005652 Completed - Clinical trials for Cognitive Dysfunction

Effects Of An 8-Weeks Mindfulness-based Intervention In Individuals With Subjective Cognitive Decline

SCD-WELL
Start date: April 21, 2017
Phase: N/A
Study type: Interventional

The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition. It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD. The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

NCT ID: NCT03005626 Completed - Clinical trials for Congenital Heart Diseases

Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

Start date: January 2017
Phase: N/A
Study type: Interventional

The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

NCT ID: NCT03004924 Completed - Clinical trials for Bacterial Conjunctivitis

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.