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NCT ID: NCT03136874 Completed - Gametes Donors Clinical Trials

Motivations and Psychological Aspects of the Gametes' Donation

DonDon
Start date: September 2016
Phase:
Study type: Observational

The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.

NCT ID: NCT03136627 Completed - Clinical trials for Carcinoma, Renal Cell

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

Start date: March 22, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6 subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6 subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will be considered the MTD. This is a validated trial design for Phase 1 trials. Following completion of the dose-escalation cohorts and determination of MTD, an expansion cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same target population.

NCT ID: NCT03136315 Completed - Clinical trials for Renal Insufficiency, Acute

Evaluation of the Renal Function in an Ultra-endurance Race.

INFERNAL
Start date: September 7, 2017
Phase: N/A
Study type: Interventional

During ultra endurance events, athletes experience extreme physical and mental demands, sometimes at the limits of the adaptive response to human physiology. This is particularly true for the renal function, and some evidence for acute renal failure has already been shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal failure in such ultra endurance races are not clearly elucidated. The aim of our study is to estimate glomerular filtration rate from serum and urinary creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race. Our hypothesis is that during the ultra endurance race, renal function may be injured, with a risk for the athlete.

NCT ID: NCT03136081 Completed - Septic Shock Clinical Trials

Candida Host Defense Response After Septic Shock in the Critically Ill

IMMUNOCANDIDA
Start date: June 2014
Phase: N/A
Study type: Observational

Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

NCT ID: NCT03135769 Completed - Clinical trials for Gestational Trophoblastic Neoplasias (GTN)

Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias

TROPHIMMUN
Start date: February 21, 2017
Phase: Phase 2
Study type: Interventional

Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens. Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles. There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating : - Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells. - Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center. - The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

NCT ID: NCT03135574 Completed - Ophthalmoplegia Clinical Trials

Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia

HYPER-III
Start date: April 16, 2017
Phase:
Study type: Observational

Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology. It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment. In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.

NCT ID: NCT03135496 Completed - Clinical trials for Endothelial Dysfunction

Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

DYVA2
Start date: January 5, 2017
Phase:
Study type: Observational

Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach. To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC. Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC. Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).

NCT ID: NCT03134885 Completed - Suicide, Attempted Clinical Trials

Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters

EVAL-VIGILANS
Start date: September 2016
Phase:
Study type: Observational

VigilanS is an innovative healthcare program. Participants of this program are all patients leaving in the Nord-Pas de Calais region who survived a suicide attempt. General goals of the post hospitalization monitoring system for suicidal attempters are: - Standardize general healthcare's practices by offering alert networks and innovative response procedures in case of suicidal crisis. - Coordinate the various health partners' actions around the patient (GP, psychiatrist, psychologist). - Contribute to reducing mortality and morbidity by suicide (subsequent suicide) in determined territories. The evaluation of VigilanS will be quantitative and qualitative.

NCT ID: NCT03134508 Completed - Clinical trials for Inflammatory Bowel Diseases

Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases

EVASION
Start date: March 2016
Phase: N/A
Study type: Observational

: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.

NCT ID: NCT03134495 Completed - Clinical trials for Community Infections

the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.

UTOPIE
Start date: March 2015
Phase: N/A
Study type: Observational

Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia. Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.