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NCT ID: NCT02781961 Terminated - Obesity Clinical Trials

Identification of In-vivo Probe Based Confocal Laser Endomicroscopy Cellular Characteristics in Obese Women

Start date: June 2016
Phase:
Study type: Observational

Previous studies have shown that histological changes in the gastric mucosa between obese and non-obese individuals do exist. Understanding these histological differences (between obese and non-obese individuals) might elucidate obesity pathophysiology. However, the data is scarce and even contradictory. Even less is known about the histological characteristics of the duodenal mucosa in obesity and lean states, but several studies already performed hint for some differences. These differences might influence gut hormones composition and function and play a crucial role in the development of obesity and metabolic syndrome. To our best knowledge, in-vivo, human, real-time cellular level comparison of gastric and duodenal mucosa has never been done. This can be now accomplished with pCLE. pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This optic fiber is then inserted through the working channel of a standard endoscope, bringing the microscope at the tip of the fiber to close proximity with the tissue. The system applies a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein, once) provides a cellular-level, in-vivo, real time images: the concept of so called "optical biopsies". The system has been used as an auxiliary tool in GI-endoscopy in recent years. This technology has been shown to be useful in identifying objective histological features and even intramucosal bacteria in different tissues.

NCT ID: NCT02767596 Terminated - Clinical trials for Diabetes Mellitus Type 2

Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

Start date: July 12, 2016
Phase: Phase 4
Study type: Interventional

The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting GLP-1 analog. Patients who fail to achieve significant improvement in diabetes control on basal insulin and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The primary outcomes will be changes in HBA1C and weight.

NCT ID: NCT02745145 Terminated - Clinical trials for Systemic Sclerosis-associated Interstitial Lung Disease

Abituzumab in SSc-ILD

Start date: May 31, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

NCT ID: NCT02736318 Terminated - Clinical trials for Talus Osteochondral Defect

OD-PHOENIX in Talus Osteochondral Lesion

TBF3
Start date: January 27, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.

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: 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: 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: NCT02715804 Terminated - Clinical trials for Pancreatic Ductal Carcinoma

A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Start date: March 14, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

NCT ID: NCT02711241 Terminated - Gastroenteritis Clinical Trials

Optimal Analgesia in Acute Gastroenteritis

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study

NCT ID: NCT02697136 Terminated - Clinical trials for Familial Hypoalphalipoproteinemia

CER-001 Therapy as a Novel Approach to Treat Genetic Orphan Diseases

TANGO
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.