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NCT ID: NCT02864992 Active, not recruiting - Clinical trials for Lung Adenocarcinoma Stage IIIB/IV

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Start date: September 13, 2016
Phase: Phase 2
Study type: Interventional

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

NCT ID: NCT02864836 Active, not recruiting - Clinical trials for Head and Neck Tumors

Study of Copper Isotope in Head and Neck Cancer

ISOTOPE
Start date: May 15, 2017
Phase:
Study type: Observational

The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals. The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis. Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways. Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum. Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors. The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA). Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors. The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not. In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.

NCT ID: NCT02864797 Active, not recruiting - Gynecologic Cancers Clinical Trials

Feasibility Study of a Prospective and Pragmatic Cohort

GYNEQOL-Pilot
Start date: September 29, 2015
Phase: N/A
Study type: Interventional

Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an important part of the female cancer in France with more than 15 000 new cases in 2012. As considerable progress have been made in diagnostic and therapeutic strategies, an important part of the gynecologic cancers are diagnosed at an early stage and globally, the after treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of evident interest to study health related Quality of Life (QoL) among these patients who will continue to live after their cancer and to consider QoL as a primary end-point, beyond overall survival. The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a working group initiated in Besançon and whose goal is to investigate QoL of gynecologic cancers' patients. It gathers several entities from the hospital of Besançon, namely the Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical practice, with the main objective of longitudinally collecting and analyzing QoL data of these women. The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in September 2015 with the goal of assessing the feasibility of the cohort. The feature of this study is that patients answer to QoL questionnaires using tablets computer and the Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions to collect patient reported outcomes is drastically increasing those last years. It has been underlined that routinely collecting symptoms could increase both QoL and survival among cancer patients. It enables to use these data in real-time in routine practice by presenting QoL scores to physicians in simple graphical histograms for both transversal and longitudinal measurements and it ensures a reliable data collection.

NCT ID: NCT02864004 Active, not recruiting - Parkinson's Disease Clinical Trials

Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)

EARLY-PUMP
Start date: March 3, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.

NCT ID: NCT02863978 Active, not recruiting - Infant, Premature Clinical Trials

Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

Digi-NewB
Start date: November 8, 2016
Phase: N/A
Study type: Interventional

Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

NCT ID: NCT02861989 Active, not recruiting - Osteoporosis Clinical Trials

Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.

QUALIOP
Start date: February 2014
Phase: N/A
Study type: Observational

Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines. The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.

NCT ID: NCT02861885 Active, not recruiting - Neoplasms Clinical Trials

Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon

Lesion SSL
Start date: February 24, 2016
Phase:
Study type: Observational

There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%. Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome. The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI). Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level. The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer

NCT ID: NCT02859649 Active, not recruiting - Neuropsychology Clinical Trials

Gestural Short Term and Working Memory Task

GeSTWoM
Start date: April 2016
Phase: N/A
Study type: Interventional

According to the working memory model, which accounts for the organisation of working memory, the processing of non-meaningful gestures is not clear. Some authors suggest that working memory for non-meaningful gestures has the same characteristics as the phonological loop, made up of a phonological store and of a revival process (articulatory rehearsal). These characteristics are evidenced in memory span tasks, memory span which is itself determined by the duration of the memory trace and the time required to refresh the trace by subvocal rehearsal. The investigators therefore aim to set up a gestural working memory task, which is specific, simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first be an exploratory and descriptive study with healthy subjects.

NCT ID: NCT02858635 Active, not recruiting - Suicidal Behaviour Clinical Trials

Molecular Genetics of Suicidal Behavior

Start date: September 2001
Phase: N/A
Study type: Interventional

Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB. The four goals of this project are in the continuity of previous works team: 1. To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently. 2. To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors. 3. To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction. 4. To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation. The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.

NCT ID: NCT02856971 Active, not recruiting - TKA Infection Clinical Trials

Knee Hinge Prosthesis Following TKA Infection

Start date: December 2015
Phase: N/A
Study type: Observational

Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.