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NCT ID: NCT03720444 Not yet recruiting - Low Back Pain Clinical Trials

"Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"

Mc-SubLomb
Start date: January 1, 2019
Phase:
Study type: Observational

The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain. Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain. The main objective of this study will be to evaluate the pain of patients managed by the MDT method. The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases. This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.

NCT ID: NCT03718078 Not yet recruiting - Hepatocarcinoma Clinical Trials

Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

PERSEE
Start date: March 2019
Phase: N/A
Study type: Interventional

This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

NCT ID: NCT03716986 Not yet recruiting - Glioma Clinical Trials

Multimodal Imaging of Hypoxia in Gliomas

GLIOXYMAGE
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg). Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI. This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO. The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET. The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2). This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.

NCT ID: NCT03702972 Not yet recruiting - Burns Second Degree Clinical Trials

Thermal Imaging and Pediatric Burns

FLIRPED
Start date: October 2018
Phase:
Study type: Observational

The need to cover a burn with a skin graft is determined primarily by its depth. In fact only burns of the second deep degree or the third degree are likely to be grafted. However, if the diagnosis is obvious in the case of third degree burns, second degree burns are often "mixed" with more or less deep areas, especially in pediatrics. Clinical experience and daily observation of the burn since its occurrence currently determine the indication for surgery. In practice, it is rare to be able to determine with certainty whether a second degree mixed burn will require a graft before the 10-12th day of evolution. There are currently devices that can help refine the diagnosis such as laser Doppler, but they are expensive devices, and not 100% reliable. The thermal camera Flir-one® attaches to a smartphone or tablet and allows thanks to a free application, to obtain a thermogram of the pointed area. This is a device used to detect insulation deficits in the building sector. Knowing that a deep burn, by devascularization, will have an external temperature lower than a superficial burn, a thermogram would thus make it possible to better identify the deep zones and the superficial zones of the burn. One study showed a good sensitivity and specificity of the device but it was a population of adult patients. This determined that a difference in skin temperature between a deep burned area and healthy skin should be at least 1.15 ° C in favor of healthy skin, to retain a burn as deep, and not to operate so-called superficial burn if this difference was below this threshold. However, further studies would be needed to demonstrate the validity of this method in clinical practice.

NCT ID: NCT03694964 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Severe Chronic Respiratory Failure and Citrulline

Start date: January 2019
Phase: N/A
Study type: Interventional

Because of its very high bioavailability and its specific and direct action on protein synthesis, the investigators hypothesize that citrulline supplementation would be an innovative nutritional strategy to improve the peripheral muscle mass and strength in COPD patients with severe chronic respiratory failure. This supplementation would be more effective if the pathology is severe and the chronic systemic inflammation important. The benefits of this supplementation could help the most severe patients break out of the cycle of inactivity and thus optimize their quality of life. The main objective of this study is to evaluate the impact of 45-day nutritional supplementation with Citrulline (10 g / day) on the body composition (lean body mass) in malnourished COPD patients with severe chronic respiratory failure.

NCT ID: NCT03694795 Not yet recruiting - Functional Autonomy Clinical Trials

Effets of a Serious Game With Elderly People

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.

NCT ID: NCT03690830 Not yet recruiting - Clinical trials for Recurrent Pregnancy Loss

Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization

ENDOMETAB
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility. The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.

NCT ID: NCT03686774 Not yet recruiting - Neuropathic Pain Clinical Trials

Memantine and Post-mastectomy Neuropathic Pain

CLEMANTINE
Start date: February 15, 2019
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.

NCT ID: NCT03681834 Not yet recruiting - Vascular Surgery Clinical Trials

Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

RECORVA
Start date: September 2018
Phase:
Study type: Observational

The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.

NCT ID: NCT03681379 Not yet recruiting - Acute Heart Failure Clinical Trials

Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

PALMAréa
Start date: October 1, 2018
Phase:
Study type: Observational

To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)