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NCT ID: NCT02378688 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD) - To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

NCT ID: NCT02378532 Completed - Clinical trials for Glioblastoma Multiforme

The Addition of Chloroquine to Chemoradiation for Glioblastoma

CHLOROBRAIN
Start date: August 2016
Phase: Phase 1
Study type: Interventional

Patients with a glioblastoma (GBM) have a poor prognosis with a median survival of 14.6 months after maximal treatment with a resection and chemoradiation. Since the pivotal trial evaluating the effect of temozolomide (TMZ), overall survival has not increased. Treatment of GBM xenografts in vivo with chloroquine (CQ), an antimalarial agent, has been shown to reduce the hypoxic fraction and sensitizes tumors to radiation. Epidermal growth factor receptor (EGFR) amplification or mutation is regularly observed GBM and is thought to be a major contributor to radioresistance. The most common EGFR mutation in GBM (EGFRvIII) is present in 50-60% of patients whose tumor shows amplification of EGFR. EGFR provides cells with a survival advantage through autophagy when exposed to stresses such as hypoxia and nutrient starvation. This effect is even more pronounced in EGFRvIII overexpressing tumors. Previously, the potential effect CQ has been demonstrated in a small randomized controlled trial in GBM treated with radiotherapy and carmustine, which showed a trend towards increased overall survival. However, as the intracellular effects of chloroquine are dose-dependent the maximum tolerated dose for CQ in combination with concurrent radiotherapy with daily temozolomide needs to be established.

NCT ID: NCT02377934 Completed - Clinical trials for Pulmonary Hypertension

Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study

MRI-HART
Start date: September 2012
Phase:
Study type: Observational

In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis. The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.

NCT ID: NCT02377648 Completed - Clinical trials for Cardiac Allograft Vasculopathy

Safety and Efficacy of Everolimus - Eluting Bioresorbable Vascular Scaffold for Cardiac Allograft Vasculopathy

CART
Start date: January 2015
Phase: Phase 4
Study type: Interventional

The CART Pilot study was designed to provide preliminary observations (about performance and safety) and generate hypotheses for future studies . The primary goal of the study is to evaluate the performance at one year of second-generation ABSORB Bioresorbable Vascular Scaffold (BVS)(Abbott Vascular, Santa Clara, CA , USA), the Everolimus Eluting Bioresorbable Vascular Scaffold, in heart transplant recipients affected by cardiac allograft vasculopathy (CAV) and significative coronary stenosis. The secondary objectives are: - to collect data about the procedural and clinical outcomes post-procedure , 30 days, 180 days and at 1,2 and 3-year follow-up, of patients who underwent ABSORB BVS implantation in order to investigate the safety of the device in CAV population; - to evaluate the progression of the disease and the its interactions with the study device by using data derived from multi-imaging invasive techniques. The vascular reparative therapy and in particular the BVS technology showing important advantages in terms of endothelial preservation, adequate vasomotion, and restoration of the media and adventitia of the vessel wall, could represent a new and more effective therapeutic option, compared to bare-metal and drug-eluting stent technologies, for transplanted patients, since all these mechanisms may, at least in part, counteract the detrimental changes leading to CAV, namely constrictive remodeling and rapid atherosclerosis progression. Subjects enrolled into the clinical study will be male or female derived from the heart transplant recipients population of every participating center. The clinical study will enroll 30 subjects. Subjects, who underwent the yearly expected coronary angiography follow-up after heart transplant surgery, meeting the general and angiographic inclusion and exclusion criteria (eligibility will be assessed by Heart Team consensus) will be asked to sign an informed consent form. Subjects who do not meet inclusion and exclusion criteria are subject to the standard follow-up of heart transplant (HTx) recipients and will undergo to an invasive evaluation after 365 ± 28 days. The study comprises two distinct phases: - the enrollment phase which starts with the recruitment of the first subject and it is planned to last one year; - the follow-up phase which is planned to last three years from the enrollment of the last patient. The total duration of the study will be of four years, including both the enrollment and the follow-up phases

NCT ID: NCT02376738 Completed - Clinical trials for Coronary Artery Disease

Regional Activation of Leukocytes in Coronary Artery Disease

REAL-CAD
Start date: July 2007
Phase: N/A
Study type: Observational

This study aims to evaluate the role of leukocyte activation in coronary artery disease

NCT ID: NCT02376309 Completed - Muscle Atrophy Clinical Trials

The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

Le-Na
Start date: August 2015
Phase: N/A
Study type: Interventional

A decrease in muscle mass can have a profound impact on quality of life, as it can lead to decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this study we investigate whether ingesting leucine or getting a ND injection will reduce the loss of muscle mass and strength.

NCT ID: NCT02376270 Completed - Healthy Elderly Clinical Trials

Pectin, Aging and Intestinal Barrier Function

Start date: March 2015
Phase: Phase 4
Study type: Interventional

The population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. intestinal barrier function, immune function and microbial composition. As intestinal barrier function may be compromised in the elderly we will investigate whether the effects of pectin on selected parameters of gut health differ between young vs. older individuals. The primary objective of this study is to investigate the effects of aging on pectin-induced changes in intestinal permeability. Furthermore, this study has seven secondary objectives. This study conforms to a randomized, double-blind and placebo-controlled design including two parallel arms.The study population consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30 kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before and after the supplementation period, several measurements will take place. The main study parameter is the change in urinary sugar excretion ratio before and after the intervention period.

NCT ID: NCT02375945 Completed - Lymphedema Clinical Trials

Comparison Between a Non-elastic Falcro Device and Current Method After Total Knee Arthroplasty

Start date: March 2015
Phase: Phase 4
Study type: Interventional

Swelling is a common problem after knee arthroplasty often leading to delayed wound healing, lasting functional impairment and hematoma. Due to this complications, sometimes the risk for deep venous thrombosis is raised. This study investigates a new self adjustable device to reduce swelling more effective postoperatively. The investigators compare the new device to the current general practice by using a standard class 1 elastic stocking

NCT ID: NCT02375204 Active, not recruiting - Germ Cell Tumor Clinical Trials

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Start date: August 5, 2015
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

NCT ID: NCT02373904 Completed - Clinical trials for Humerus Pathological Fracture

A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

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

The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.