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NCT ID: NCT04062721 Not yet recruiting - Clinical trials for Unresectable Colorectal Liver Metastases

Local Immunomodulation After Radiofrequency of Unresectable Colorectal Liver Metastases

LICoRN-01
Start date: June 2021
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to determine feasibility and tolerance of the human body to RFA associated with local immunomodulation carried out using a thermoreversible hydrogel combined with 2 immunomodulators, GMCSF and Mifamurtide. The main endpoint of the study is the feasibility, the frequency and the nature of per and post-operative adverse events of the in situ injection of an immunomodulatory hydrogel after radiofrequency of unresectable colorectal liver metastases. The secondary objective is one-year progression free survival rate.

NCT ID: NCT04053114 Not yet recruiting - Ovarian Cancer Clinical Trials

MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

MOLTHYSO
Start date: September 2019
Phase:
Study type: Observational

Thyroid carcinoma on struma ovarii (TCSO) is a rare ovarian tumor, derivate from monodermic teratomas. It represents about 0.01% of overall ovarian tumours, and 5 to 10% of struma ovarii. The diagnosis is histologic and retrospective after pelvic surgery. Because of its rarity, the treatment of TCSO is not consensual and should be validated in multidisciplinary team involved in rare ovarian carcinoma. TCSO should be taken care of as a thyroid carcinoma, in case of relapse, with systemic treatment, as tyrosine kinase inhibitor (TKI), without any clinical trial proving this benefit. Indeed, molecular profiles and genomic expression is unknown, because of studies with few patients (less than 10) contrary to thyroid carcinomas with the TCGA genomic classification. The study purposes are the outcome of the patients after the first treatment and the comparison of the genomic profil in next generation sequencing (NGS) with TCGA thyroid carcinoma profile. Thus, the treatment could be tailored, confirming the same therapy as in thyroid carcinoma.

NCT ID: NCT04051086 Not yet recruiting - Vasculopathy Clinical Trials

Quantification of Elastin Markers Synthesis in Williams-Beuren Syndrome and 7q11.23 Micro-duplication Syndrome

ELAST7
Start date: October 2019
Phase: N/A
Study type: Interventional

Introduction: Williams-Beuren syndrome is a rare genetic disorder caused by a 7q11.23 microdeletion. The phenotype associates vasculopathy (arterial stenosis, hypertension), dimorphism and intellectual disability. Microdeletion includes several genes: ELN encodes for elastin and the haplo-insufficiency (only 1 functional copy) causes vasculopathy. The primary objective is to quantify plasma and urinary levels of elastin peptides in Williams-Beuren patients and 7q11.23 micro-duplication syndrome patients in order to correlate the levels of these markers with the number of copies of ELN gene (proportional positive relationship "gene copy number - circulating levels of markers) Materials and Methods: This prospective study will be carried out in Lyon at the "Hôpital Femme-Mère-Enfant" for 2 years. 3 groups of patients will be studied: Williams-Beuren patients (N=20), micro-duplication 7q11.23 syndrome patients (N=10) and healthy patients (N=60). Subjects will be followed for 1 day. Clinical examination (weight, height, blood pressure) and biological sample collection (blood and urine sample) will be carry out for Williams Beuren and micro-duplication 7q11.23 patients group. A large majority of visits will be part of patients' usual care. A large part of patients are systematically seen in consultation once a year. For healthy group, only biological sample collection will be carry out. The PE concentrations will be assessed and compared between the three groups of patients.

NCT ID: NCT04046276 Not yet recruiting - Parkinson's Disease Clinical Trials

Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease

AEROPROTECT
Start date: September 2019
Phase: N/A
Study type: Interventional

In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.

NCT ID: NCT04041752 Not yet recruiting - Clinical trials for Healthy Normal Weight

Meal Texture and Satiety

FEED
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.

NCT ID: NCT04027725 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

NEUROFEEDBACK TRAINING FOR OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT: A PILOT STUDY

NEUROFEEDEL
Start date: November 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of SMR neurofeedback training on cognitive performance and electrical brain activity in elderly with cognitive impairment.

NCT ID: NCT04023786 Not yet recruiting - Clinical trials for Mechanical Ventilation

Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

PEEP-TEST
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.

NCT ID: NCT04022330 Not yet recruiting - Clinical trials for Left Ventricular Hypertrophy

Protective Monocytes and Macrophages to Limit Decompensation and Heart Damaging

PROMOMA
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The working hypothesis is that cardiac macrophages specific for the compensated cardiac hypertrophic phase limit the progression toward the decompensated state of heart failure by promoting an inflammatory environment favouring cardiomyocyte survival and preservation of the pump function. The investigators will perform studies in human plasma and monos, cardiac tissues and macrophages to validate this hypothesis.

NCT ID: NCT04020263 Not yet recruiting - Cardiogenic Shock Clinical Trials

Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

LevoHeartShock
Start date: December 1, 2019
Phase: Phase 3
Study type: Interventional

Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

NCT ID: NCT04020120 Not yet recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder in Adults

Assessment of the Professional Difficulties of Adult With Attention Deficit / Hyperactivity Disorder Patients

WORKTDA
Start date: December 2019
Phase:
Study type: Observational

Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired. The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels. The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview. The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.