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NCT ID: NCT02489344 Completed - Fabry Disease Clinical Trials

Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease

Start date: July 7, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344). Secondary Objective: To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy endpoints in adult male participants with Fabry disease who previously completed study ACT13739.

NCT ID: NCT02489292 Completed - Clinical trials for Urea Cycle Disorders

Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002)

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients suffering from urea cycle disorders.

NCT ID: NCT02488759 Completed - Clinical trials for Various Advanced Cancer

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

CheckMate358
Start date: October 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: - Anal canal cancer-No longer enrolling this tumor type - Cervical cancer - Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type - Merkel Cell Cancer - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type - Nasopharyngeal Cancer - No longer enrolling this tumor type - Head and Neck Cancer - No longer enrolling this tumor type

NCT ID: NCT02488395 Completed - Parkinson's Disease Clinical Trials

Superior Colliculus Activity in Parkinson Disease: a Potential Marker?

AGIRPARK
Start date: October 7, 2015
Phase:
Study type: Observational

The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker. Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early deficit in visual processing. The investigator's data also suggests that with the evolution of the disease, this structure presents a neuronal re-organisation leading which causes a sensory rebound after the introduction of the treatment. The light responses in the superior colliculus were faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an important question about the superior colliculus functional state in Parkinson's patients. If this structure have a similar neuroplasticity, the investigators could hypothesize that the superior colliculus may also present a sensory rebound when introducing the treatment. If this hypothesis is true, the accelerated and amplified light responses of this structure may explain the difficulties felt by the patients to inhibit reflexive saccades induced by the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the orientation of the head and eye toward any sudden changes in our environment (Wurtz and Albano, 1980) and the light responses of this structure are strongly correlated with the speed of the saccade (Marino et al., 2012). Therefore, the investigators want to test if a similar deficit could be observed in the superior colliculus of newly diagnosed PD patients. Data will be compared to matching controls.

NCT ID: NCT02488369 Completed - Clinical trials for Non-Hodgkin Lymphoma

Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents

TEP-LYMPHOME
Start date: March 31, 2011
Phase: N/A
Study type: Interventional

This is a diagnostic prospective multicenter study. This study will be conducted in 32 centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with conventional imaging time of remission assessment. Histological examination of residual tumor will be conducted whenever practicable in patients with pathologic residual image on conventional imaging and / or PET / CT. A central review of conventional imaging examinations and PET / CT will be performed independently from each other. Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The results of the early PET / CT should not lead to treatment modifications. In case of residual tumor at remission assessment, therapeutics changes as recommended therapeutic protocols will be based on histologic findings and not on the results of PET / CT alone.

NCT ID: NCT02488330 Completed - Solid Tumor Clinical Trials

An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

Start date: August 27, 2015
Phase: Phase 3
Study type: Interventional

This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.

NCT ID: NCT02487836 Completed - Clinical trials for Adenocarcinoma of Head of Pancreas

Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas

PROPAC
Start date: October 2013
Phase: Phase 2
Study type: Interventional

For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt. Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability). However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN. In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder). It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.

NCT ID: NCT02486965 Completed - Fibromyalgia Clinical Trials

Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects

DOUFISPORT
Start date: October 7, 2015
Phase: N/A
Study type: Interventional

Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome. The aim of this study is the evaluation of a specific training program on controls of pain in fibromyalgia patients by balancing the stress axis. The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured during the test of the thermode (difference between the average VAS measured between the 10th and 40th second of P1 and the average VAS measured between the 10th and 40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will be compared in the two groups..Salivary cortisol is also tested.

NCT ID: NCT02486731 Completed - Noonan Syndrome Clinical Trials

Hormonal Sensitivity in Patients With Noonan and LEOPARD Syndromes

NOLEO
Start date: December 16, 2015
Phase:
Study type: Observational

Noonan and LEOPARD syndromes share, with variable severity, different clinical traits, notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers. The main genetic cause of these syndromes is missense mutation of the gene encoding the ubiquitous tyrosine phosphatase Shp2, found in more than half the patients with NS and in 80% of LS cases. Shp2 plays pivotal roles in development, growth, and metabolism by regulating key signalling pathways (Ras/Mitogen activated protein kinase (MAPK), Phosphoinositide-3 Kinases (PI3K)/Akt) in response to growth factors/hormones. Deregulation of these signalling pathways has been causally linked to NS and LS pathophysiology. This project aims at better understanding hormonal sensitivity abnormalities in patients with Noonan syndrome (NS) or LEOPARD syndrome (LS) caused by mutations of the tyrosine phosphatase Shp2. To reach this goal, the investigators will take advantage of different tissues (fibroblasts ± adipocytes) from patients with NS / LS compared to healthy controls. All patients will have a skin biopsy and only patients about to undergo surgery will have a adipose tissue biopsy.

NCT ID: NCT02486341 Completed - Diabetes Clinical Trials

Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin

VARQUOGLY
Start date: March 31, 2016
Phase: N/A
Study type: Interventional

Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients. The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.