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NCT ID: NCT02894996 Completed - Anesthesia Clinical Trials

Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?

PEDIFLUID
Start date: September 28, 2016
Phase: N/A
Study type: Interventional

To predict fluid responsiveness in anesthetized pediatric patient is not an easy task although anesthesia provider has to deal with this question on their daily practices. Today, very few parameters can help anesthesia provider to predict fluid responsiveness in the pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge with high volume of fluid boluses to see if patient were fluid responsive or not. This could lead to fluid overload and it's associated morbidity. We would like to investigate if the cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric anesthetized patients.

NCT ID: NCT02894827 Completed - Nutritional Status Clinical Trials

The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years

MEDICANUT2
Start date: n/a
Phase: N/A
Study type: Observational

Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a medication and digestive tolerance are ensured, the medication can be taken a long time from meals to reduce its side-effects. Despite numerous studies that have investigated links between medication and malnutrition, none have assessed the influence of the time the drug is taken on the evolution of the nutritional status of elderly hospitalized persons. So as to identify the best nutritional criterion in hospitalized persons, a retrospective pilot study will be conducted in about thirty patients. Their medication will be recorded and their nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form. This preliminary study will allow us to choose the best nutritional criterion to compare the impact of two strategies for taking medication (post prandial versus pre-prandial) on improving the nutritional status of malnourished elderly hospitalized patients taking multiple drugs.

NCT ID: NCT02894801 Completed - Colorectal Cancer Clinical Trials

Multistate Relative Survival Model

MRS
Start date: January 2013
Phase: N/A
Study type: Observational

Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in men to 60% in women. About one third of patients diagnosed with CRC will develop a metachronous recurrence during the following years. It is of paramount importance to accurately identify factors associated with the increased risk of progression and death, in order to develop effective follow-up and treatment strategies. However, to accurately assess the role of patients' specific characteristics in the progression of cancer several methodological challenges need to be overcome. One difficulty, common to prognostic studies of cancer, concerns the need to separate the effects of prognostic factors on different clinical endpoints, such as disease recurrence vs recurrence-free death. Another difficulty, encountered in prognostic studies, is that the cause of death is not available or not accurately coded. Yet, some patients are likely to die of causes not related to the disease of primary interest, especially in cancers with longer survival and in those that affect older subjects. Until recently, the existing statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to account for (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown causes of death. However, this challenge has been addressed by the recent development of the Markov relative survival model (MRS) , which extends the Markov multi-state model to incorporate relative survival modelling. Simulations demonstrate that MRS is able to accurately estimate different effects of prognostic factors on the risk of each of several events, including separate effects on disease-specific vs other causes of death. To date, the MRS had not been applied in clinical or epidemiological studies. The aim of this study was to assess the potential advantages of the new multi-state relative survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this end, we compared the MRS results with those obtained with two more conventional analyses, based on Cox's proportional hazards model, and the multi-state Markov model proposed by Alioum and Commenges (2001). The three models were applied to explore the impact of prognostic factors on cancer-specific mortality and recurrence, in a large population-based French registry of colorectal cancer, with up to 25 years of follow-up.

NCT ID: NCT02894775 Completed - Digestive Cancer Clinical Trials

Factors Influencing Inclusion in Digestive Cancer Clinical Trials

INDICT
Start date: January 2013
Phase: N/A
Study type: Observational

Since the early 1990s, evidence-based medicine has played an increasingly important role in decision-making for the treatment of patients with cancer. The highest level of evidence is attributed to the results of randomized comparative studies, and the public health authorities require proof from randomized therapeutic trials before authorizing the use of new treatments. Patients included in therapeutic trials benefit either from the best current treatment (control group) or from a treatment supposed to present a better or similar efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize the fight against cancer, French public health policies have led to the progressive implementation of successive nationwide "Cancer Plans" since 2003. One of the objectives is to increase the proportion of patients included in clinical research trials. Thus, the fraction enrolled in France has progressively increased but remained low at around 8% in 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a context of socio-economic inequalities that concern resources, residence and access to services, identifying factors that determine inclusion in trials will in turn highlight the reasons for non-inclusion. The aim of this study was to determine, at a population level, the influence of demographic characteristics and socio-economic status of patients with digestive cancer on inclusion in a clinical trial. Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.

NCT ID: NCT02894710 Completed - Clinical trials for Carcinologic Ear, Nose, and Throat (ENT) Surgery

Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)

ELICO
Start date: December 2016
Phase: Phase 3
Study type: Interventional

Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption. This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours. Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.

NCT ID: NCT02894632 Completed - Heart Disease Clinical Trials

MR Compatible Accelerometer for Respiratory MOTion Measurement

MARMOT
Start date: July 2013
Phase: N/A
Study type: Interventional

A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation.

NCT ID: NCT02894619 Completed - Cystic Fibrosis Clinical Trials

Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO)

PerineoMuco
Start date: January 2017
Phase:
Study type: Observational

This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

NCT ID: NCT02894580 Completed - Clinical trials for Chronic Heart Failure

Primary Prevention of Sudden Cardiac Death (PREV-DEATH)

PREV-DEATH
Start date: January 2015
Phase: N/A
Study type: Observational

The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10 years ago and implantation's conditions tend to change.

NCT ID: NCT02894437 Completed - Clinical trials for Spinal Cord Injuries

Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord

QUALIPREPS
Start date: November 2015
Phase:
Study type: Observational

The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.

NCT ID: NCT02894424 Completed - Clinical trials for Macular Hole Surgery

Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery

MICROCOL
Start date: February 23, 2017
Phase:
Study type: Observational

The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years. This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery. This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models. It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.