Clinical Trials Logo

Filter by:
NCT ID: NCT02736188 Terminated - GNE Myopathy Clinical Trials

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

NCT ID: NCT02735109 Terminated - Clinical trials for Vulvar Intraepithelial Neoplasia

Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors

Start date: April 2015
Phase: N/A
Study type: Interventional

The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin. This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology. The aim of the study is to describe the characteristics reproducibly for confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma. The patients seen in consultation with vulvar lesions suspicious looking will be included. The results will be compared systematically to the histological results of biopsies of lesions (gold standard).

NCT ID: NCT02734615 Terminated - Clinical trials for Advanced or Metastatic ER+ Breast Cancer

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Start date: June 14, 2016
Phase: Phase 1
Study type: Interventional

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.

NCT ID: NCT02734589 Terminated - Ulcerative Colitis Clinical Trials

Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

NCT ID: NCT02734017 Terminated - Re-hospitalization Clinical Trials

Impact of a Medication Review on Hospital Readmission: (ConcReHosp)

ConcReHosp
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups: 1. group receiving a pharmacist-led standardized medication review (experimental group); and 2. group not receiving the medication review (control group). The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization. Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.

NCT ID: NCT02730091 Terminated - Breast Cancer Clinical Trials

A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

VICTORIANE
Start date: February 24, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer without resistance to Aromatase Inhibitors (AI).

NCT ID: NCT02728167 Terminated - Liver Metastasis Clinical Trials

Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

HIFU-AR
Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.

NCT ID: NCT02726672 Terminated - Multiple Sclerosis Clinical Trials

Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

AIRSEP
Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.

NCT ID: NCT02725372 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

INOvation-1
Start date: April 2016
Phase: Phase 3
Study type: Interventional

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

NCT ID: NCT02721888 Terminated - Type 2 Diabetes Clinical Trials

Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

LIRA-NAFLD/LIP
Start date: July 10, 2012
Phase: Phase 4
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be associated with lipid abnormalities (such as hypertriglyceridemia and decreased HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type 2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between 3 and 5%). Animal studies have shown that liraglutide is able to decrease liver fat content, but the effect of liraglutide on liver fat content in patients with diabetes remains unknown. In addition, human studies with liraglutide have shown significant modification of plasma lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the mechanisms responsible for these liraglutide induced lipid modifications are not yet known. Because increased in liver fat content and hypertriglyceridemia are associated in patients with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver fat content assessment and kinetic study with stable isotope to study lipoprotein metabolism). This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide therapy (1.2 mg/day). Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day hospitalization For the main study, 3 visits will be performed: - a first visit at T0, before starting the treatment with liraglutide, including clinical and biological measurements and liver fat content assessment by proton-spectroscopy - a visit at 3 months including clinical and biological measurements - and a visit at 6 months including clinical and biological measurements and liver fat content assessment by proton-spectroscopy For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will been performs during a 48h-hospitalization before starting the treatment with liraglutide and after 6 month-treatment with liraglutide