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NCT ID: NCT02435030 Completed - Clinical trials for Niemann-Pick Disease, Type C

A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C

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

This is a prospective non-therapeutic observational study in NP-C patients. The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of life data. Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of the study.

NCT ID: NCT02434679 Completed - Bacteriology Clinical Trials

Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns

DAIR3N
Start date: October 2014
Phase:
Study type: Observational

Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are increasing. Among the actions to control resistance, one is an interesting lead: to prevent the emergence of resistant bacteria by limiting possibilities for bacteria to acquire resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few data on the dynamic of acquisition over time. Among the genetic components that disseminate resistance genes, resistance integrons (RI) play a major role in the acquisition and dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the first days of life. It thus appears to be an appropriate model to study the dynamic of resistance acquisition. This project intends to follow the NB of neonatology over time in order to study the dynamic of the digestive acquisition of RI and MRB

NCT ID: NCT02434588 Completed - Small Pupil Clinical Trials

Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)

ADICC-ID
Start date: April 14, 2015
Phase: N/A
Study type: Interventional

During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm. At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device. This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring. Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.

NCT ID: NCT02434120 Completed - Orbital Tumor Clinical Trials

MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

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

Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation. Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers. The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients. For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors. In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.

NCT ID: NCT02433613 Completed - Atrial Fibrillation Clinical Trials

Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance. Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

NCT ID: NCT02433522 Completed - Clinical trials for ANCA-associated Vasculitides

Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab

MAINRITSAN3
Start date: March 31, 2015
Phase: Phase 3
Study type: Interventional

MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data). Right now, no randomized controlled study has been carried in order to evaluate the best duration of the maintenance treatment with rituximab. The investigators objective is to evaluate the efficacy of a long term rituximab treatment to prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase of rituximab maintenance treatment. The investigators will conduct a randomized placebo-controlled trial of a long term rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18 months).

NCT ID: NCT02433379 Completed - Clinical trials for Ventricular Tachycardia

Understanding Outcomes With the EMBLEMâ„¢ S-ICD in Primary Prevention Patients With Low Ejection Fraction

UNTOUCHED
Start date: June 9, 2015
Phase: N/A
Study type: Interventional

This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

NCT ID: NCT02433366 Completed - Atrial Fibrillation Clinical Trials

Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

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

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

NCT ID: NCT02432976 Completed - Quality of Life Clinical Trials

Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients

ExeQOL
Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

A diminution of quality of life is often reported by patients after coronary artery bypass graft (CABG) surgery. A part of this diminution could be explain by postoperative left ventricular (LV) dysfunction. Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. Recent data have suggested that exenatide could improve LV function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. Moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo. The investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in CABG surgery patients.

NCT ID: NCT02432846 Completed - Clinical trials for Renal Cell Carcinoma, Metastatic

Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

MERECA
Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.